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A Study of the Effectiveness and Safety of Sustained-release Hydromorphone (a Strong Opioid) in Patients With Chronic Noncancer Pain.

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ClinicalTrials.gov Identifier: NCT00261495
Recruitment Status : Completed
First Posted : December 5, 2005
Results First Posted : December 24, 2012
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutica N.V., Belgium

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: OROS hydromorphone HCl
Drug: Oxycodone
Enrollment 504
Recruitment Details Study conducted in 11 countries (Czech Republic, Denmark, France, Germany, Italy, Norway, Poland, Slovakia, Slovenia, Sweden, and Switzerland). 63 study centres randomized subjects and 1 centre screened 1 subject but did not randomize. Recruitment period: 15 March 2006 (first patient in) to 31 March 2007 (last patient in).
Pre-assignment Details  
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase) Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Period Title: Titration Phase (Weeks 0 to 4)
Started 254 250
Completed 206 185
Not Completed 48 65
Reason Not Completed
Adverse Event             28             36
Withdrawal by Subject             6             11
Lack of Efficacy             8             8
Physician Decision             3             1
Non-compliance             2             5
Protocol Violation             1             4
Period Title: Maintenance Phase (Weeks 4 to 24)
Started 206 185
Completed 140 137
Not Completed 66 48
Reason Not Completed
Adverse Event             29             20
Lack of Efficacy             14             10
Withdrawal by Subject             6             5
Non-compliance             1             5
Protocol Violation             5             2
Other             6             5
Physician Decision             1             1
Treatment completed, no follow-up             2             0
Lost to Follow-up             2             0
Period Title: Extension Phase (Weeks 24 to 52)
Started 60 [1] 52 [2]
Completed 50 47
Not Completed 10 5
Reason Not Completed
Other             4             2
Adverse Event             4             1
Lack of Efficacy             0             1
Withdrawal by Subject             0             1
Non-compliance             1             0
Lost to Follow-up             1             0
[1]
Number started is different to number completed maintenance phase owing to drop outs (80 subjects).
[2]
Number started is different to number completed maintenance phase owing to drop outs (85 subjects).
Arm/Group Title OROS Hydromorphone HCl Oxycodone Total
Hide Arm/Group Description Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase) Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase) Total of all reporting groups
Overall Number of Baseline Participants 254 250 504
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 254 participants 250 participants 504 participants
57.1  (13.06) 58.0  (12.82) 57.5  (12.93)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 254 participants 250 participants 504 participants
Female
142
  55.9%
152
  60.8%
294
  58.3%
Male
112
  44.1%
98
  39.2%
210
  41.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 254 participants 250 participants 504 participants
Czech Republic 34 18 52
Denmark 19 20 39
France 22 18 40
Germany 83 80 163
Italy 17 21 38
Norway 18 18 36
Poland 28 34 62
Slovakia 11 11 22
Slovenia 3 5 8
Sweden 14 19 33
Switzerland 5 6 11
1.Primary Outcome
Title Change From Baseline in Brief Pain Inventory (BPI) Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Per Protocol [PP] Population)
Hide Description Assessment of non-inferiority of OROS hydromorphone compared with sustained release (SR) oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 "pain right now" score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
PP population (all randomized subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 115 108
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.8  (2.04) -3.2  (2.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments

Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.

Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.

Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power).

Type of Statistical Test Non-Inferiority or Equivalence
Comments Tested using 95% confidence interval approach. The non-inferiority margin was 1.
Statistical Test of Hypothesis P-Value 0.011
Comments Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means & error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).
Method ANCOVA
Comments If the right side of CI<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.29
Confidence Interval 95%
-0.27 to 0.84
Estimation Comments LS mean difference has been presented, which was calculated as hydromorphone minus oxycodone.
2.Primary Outcome
Title Change From Baseline in BPI Questionnaire Item 6 "Pain Right Now" Score at Week 24 (Intent to Treat [ITT] Population)
Hide Description Assessment of non-inferiority of OROS hydromorphone compared with SR oxycodone with regard to pain control by measuring the change from baseline in pain severity, using BPI item 6 "pain right now" score at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 233 223
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.1  (2.43) -2.1  (2.41)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments

Null hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was less than or equal to 1.

Alternative hypothesis: Difference in change from baseline with OROS hydromorphone compared with SR oxycodone was greater than 1.

Sample size needed to detect a clinically significant difference of 1 was 151 per treatment arm (standard deviation = 2.4, significance level 0.025 one-sided, based on 90% power).

Type of Statistical Test Non-Inferiority or Equivalence
Comments Tested using 95% confidence interval approach. The non-inferiority margin was 1.
Statistical Test of Hypothesis P-Value <0.001
Comments Statistical significance level was 0.05. Two-sided 95% CI of the treatment difference based on LS means & error terms obtained from ANCOVA (covariate: baseline; factors: country, previous pain treatment, underlying disease, and treatment).
Method ANCOVA
Comments If the right side of CI<1 then the null hypothesis was rejected in favour of the alternative, and non-inferiority of OROS hydromorphone was concluded.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.12
Confidence Interval 95%
-0.53 to 0.29
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
3.Primary Outcome
Title Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (PP Population)
Hide Description If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.
Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 115 108
Mean (Standard Deviation)
Unit of Measure: mg per day
18.9  (9.44) 48.3  (22.4)
4.Primary Outcome
Title Equi-analgesic Dosage of OROS Hydromorphone Once-daily and SR Oxycodone Twice-daily (ITT Population)
Hide Description If non-inferiority of OROS hydromorphone was established, the daily dose of OROS hydromorphone and SR oxycodone that induced the same pain control was to be calculated (average dose used at week 24). Relative equi-analgesic dose was defined as mean dose/allowed maximum dose*100. Allowed maximum doses were 32mg OROS hydromorphone and 80mg SR oxycodone respectively.
Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: mg per day
18.4  (9.92) 43.8  (23.12)
5.Primary Outcome
Title Equi-analgesic Dose at Steady-state (PP Population)
Hide Description Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.
Time Frame week 4 to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
PP population (all subjects who took the study medication at least once, who had post-baseline efficacy data, and who were without major protocol violation)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 115 108
Mean (Standard Deviation)
Unit of Measure: mg per day
18.95  (9.223) 47.82  (21.663)
6.Primary Outcome
Title Equi-analgesic Dose at Steady State (ITT Population)
Hide Description Dose of OROS hydromorphone and SR oxycodone that induced the same pain control at steady state, defined as the mean dose from week 4 to week 24.
Time Frame week 4 to week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: mg per day
19.50  (9.584) 48.41  (21.835)
7.Secondary Outcome
Title Change From Baseline in BPI Pain Severity Sub-score "Pain at Its Worst" (BPI Item 3) at Week 24 (ITT Population)
Hide Description Change from baseline to week 24 in BPI pain severity, pain at its worst (BPI item 3) assessed using the BPI questionnaire. Score values ranges from 0 (no pain) to 10 (pain as bad as you can imagine). Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its worst".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.9  (2.20) -1.9  (2.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments

Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.

Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.706
Comments A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure was stopped here, subsequent tests were exploratory in nature.
Method ANCOVA
Comments Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.08
Confidence Interval 95%
-0.32 to 0.47
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
8.Secondary Outcome
Title Change From Baseline in Sleep Quality at Week 24
Hide Description Change from baseline in sleep quality was assessed using the Medical Outcomes Study (MOS) questionnaire at week 24, specifically the sleep subscale index I. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improved sleep quality.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-8.8  (18.44) -6.2  (18.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments

Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.

Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.065
Comments A two-sided significance level of 0.05 was used. A closed hierarchical testing procedure was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.
Method ANCOVA
Comments Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.87
Confidence Interval 95%
-5.94 to 0.19
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
9.Secondary Outcome
Title Change From Baseline in Subject Diary Evening Mean Pain Score "Pain Right Now" at Week 24
Hide Description Change from baseline to week 24 in subject diary evening mean pain score "pain right now". Subjects rated the severity of "pain right now" on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score "pain right now".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.2  (2.08) -2.0  (2.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments

Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.

Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.348
Comments A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.
Method ANCOVA
Comments Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.20
Confidence Interval 95%
-0.62 to 0.22
Estimation Comments Mean difference was calculated: hydromorphone minus oxycodone
10.Secondary Outcome
Title Change From Baseline in Subject Diary Morning Mean Pain Score "Pain Right Now" at Week 24
Hide Description Change from baseline to week 24 in subject diary morning mean pain score "pain right now". Subjects rated the severity of "pain right now" on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary evening mean pain score "pain right now".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.0  (2.33) -2.0  (2.20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments

Null hypothesis: Difference in change from baseline between hydromorphone and oxycodone was equal to zero.

Alternative hypothesis: Difference in change from baseline between hydromorphone and oxycodone was not equal to zero.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.616
Comments A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Procedure has been stopped, test is exploratory in nature.
Method ANCOVA
Comments Superiority of OROS hydromorphone compared to SR oxycodone was evaluated.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.11
Confidence Interval 95%
-0.54 to 0.32
Estimation Comments Mean difference was calculated: hydromorphone minus oxycodone
11.Secondary Outcome
Title Number of Subjects With Dose Escalation
Hide Description Number of subjects with dose increase in study medication.
Time Frame week 4 and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 203 182
Measure Type: Number
Unit of Measure: Subjects
Yes 27 34
No 176 148
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments

Null hypothesis: There is no association between study medication and dose escalation.

Alternative hypothesis: There is an association between study medication and dose escalation.

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.249
Comments A two-sided significance level of 0.05 was used. A closed hierarchical testing approach was used to control the overall Type I error. Hierarchical testing procedure has been stopped, test is exploratory in nature.
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel Chi-squared statistic stratified for country was used.
12.Secondary Outcome
Title Change From Baseline in BPI Severity Score "Pain Right Now" (BPI Item 6) at Week 4
Hide Description Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain right now" (BPI item 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain right now".
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.2  (2.34) -2.6  (2.26)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
Comments 0.05 two-sided testing, exploratory comparison
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.42
Confidence Interval 95%
-0.00 to 0.84
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
13.Secondary Outcome
Title Change From Baseline in BPI Pain Severity Score "Pain at Its Least" (BPI Item 4) at Week 4
Hide Description Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain at its least" (BPI item 4) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its least".
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.3  (2.03) -1.8  (2.33)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.105
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.30
Confidence Interval 95%
-0.06 to 0.67
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
14.Secondary Outcome
Title Change From Baseline in BPI Pain Severity "Pain at Its Worst" (BPI Item 3) at Week 4
Hide Description Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain at its worst" (BPI item 3) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its worst".
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.8  (2.14) -2.1  (1.98)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.058
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.39
Confidence Interval 95%
-0.01 to 0.79
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
15.Secondary Outcome
Title Change From Baseline in BPI Pain Severity "Average Pain" (BPI Item 5) at Week 4
Hide Description Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "average pain" (BPI item 5) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "average pain".
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.9  (1.89) -2.1  (2.10)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.210
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.23
Confidence Interval 95%
-0.13 to 0.59
Estimation Comments Mean difference calculated: hdromorphone minus oxycodone
16.Secondary Outcome
Title Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 4
Hide Description Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 4. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
13.8  (25.15) 15.2  (26.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.941
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.18
Confidence Interval 95%
-4.87 to 4.52
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
17.Secondary Outcome
Title Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 4
Hide Description Change from baseline in BPI pain severity was assessed using the BPI questionnaire (mean of BPI items 3 to 6) at week 4. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in pain severity.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.7  (1.76) -2.0  (1.90)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.073
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.31
Confidence Interval 95%
-0.03 to 0.65
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
18.Secondary Outcome
Title Change From Baseline in BPI Pain Severity "Pain at Its Least" (BPI Item 4) at Week 24
Hide Description Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "pain at its least" (BPI item 4) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "pain at its least".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.3  (2.23) -1.4  (2.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.431
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.15
Confidence Interval 95%
-0.52 to 0.22
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
19.Secondary Outcome
Title Change From Baseline in BPI Pain Severity "Average Pain" (BPI Item 5) at Week 24
Hide Description Change from baseline in pain severity was assessed using the BPI questionnaire, specifically "average pain" (BPI item 5) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative change from baseline scores indicate improvement in "average pain".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.8  (2.07) -1.7  (2.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.835
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.04
Confidence Interval 95%
-0.40 to 0.33
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
20.Secondary Outcome
Title Change From Baseline in BPI Pain Relief Score (BPI Item 8) at Week 24
Hide Description Change from baseline in pain severity was assessed using the BPI questionnaire, specifically pain relief (BPI item 8) at week 24. Scores could have ranged from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
8.6  (29.32) 11.5  (28.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.837
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.51
Confidence Interval 95%
-5.36 to 4.35
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
21.Secondary Outcome
Title Change From Baseline in BPI Pain Severity Score (Mean of BPI Items 3 to 6) at Week 24
Hide Description Change in pain severity was assessed using the BPI questionnaire, specifically average (mean) score of BPI items 3 to 6 (worst pain, least pain, average pain, and pain right now) at week 24. Scores could have ranged from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. Negative scores indicate improvement in pain severity.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.6  (1.91) -1.7  (2.05)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.832
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.04
Confidence Interval 95%
-0.38 to 0.31
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
22.Secondary Outcome
Title Change From Baseline in BPI Interference Score "Interfered With General Activity" (BPI Item 9a) at Week 4
Hide Description Change from baseline in interference of pain was assessed using the BPI questionnaire, specifically BPI item 9a "pain interfered with general activity" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with general activity".
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.6  (2.14) -1.9  (2.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.143
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.30
Confidence Interval 95%
-0.10 to 0.71
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
23.Secondary Outcome
Title Change From Baseline in Pain Interference "Pain Interfered With Mood" (BPI Item 9b) at Week 4
Hide Description Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b "pain interfered with mood" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with mood".
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.7  (2.32) -1.9  (2.57)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.345
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.21
Confidence Interval 95%
-0.23 to 0.64
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
24.Secondary Outcome
Title Change From Baseline in Pain Interference "Pain Interfered With Walking Ability" (BPI Item 9c) at Week 4
Hide Description Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c "pain interfered with walking ability" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with walking ability".
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.2  (2.63) -1.5  (2.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.552
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.14
Confidence Interval 95%
-0.33 to 0.61
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
25.Secondary Outcome
Title Change From Baseline in Pain Interference "Pain Interfered With Normal Work" (BPI Item 9d) at Week 4
Hide Description Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d "pain interfered with normal work" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with normal work".
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.4  (2.40) -2.0  (2.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.042
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.47
Confidence Interval 95%
0.02 to 0.93
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
26.Secondary Outcome
Title Change From Baseline in Pain Interference "Pain Interfered With Relations With Other People" (BPI Item 9e) at Week 4
Hide Description Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9e "pain interfered with relations with other people" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with relations with other people".
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.1  (2.56) -1.4  (2.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.171
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.33
Confidence Interval 95%
-0.14 to 0.81
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
27.Secondary Outcome
Title Change From Baseline in Pain Interference "Pain Interfered With Sleep" (BPI Item 9f) at Week 4
Hide Description Change from baseline in pain interference was assessed using BPI questionnaire, specifically BPI item 9f "pain interfered with sleep" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 - completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with sleep".
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.1  (2.34) -2.3  (3.07)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.475
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.17
Confidence Interval 95%
-0.31 to 0.65
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
28.Secondary Outcome
Title Change From Baseline in Pain Interference "Pain Interfered With Enjoyment of Life" (BPI Item 9g) at Week 4
Hide Description Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g "pain interfered with enjoyment of life" at week 4. Scores could have ranged from 0 to 10, where 0 = does not interfere and 10 = interferes completely. Negative change from baseline scores indicate improvement in "pain interfered with enjoyment of life".
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.6  (2.62) -1.9  (2.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.359
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.23
Confidence Interval 95%
-0.26 to 0.72
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
29.Secondary Outcome
Title Change From Baseline in Pain Interference "Pain Interfered With General Activity" (BPI Item 9a) at Week 24
Hide Description Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9a "pain interfered with general activity" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with general activity".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.6  (2.42) -1.6  (2.46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.611
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.11
Confidence Interval 95%
-0.52 to 0.30
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
30.Secondary Outcome
Title Change From Baseline in Pain Interference "Pain Interfered With Mood" (BPI Item 9b) at Week 24
Hide Description Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9b "pain interfered with mood" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with mood".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.4  (2.85) -1.3  (2.88)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.526
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.15
Confidence Interval 95%
-0.60 to 0.31
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
31.Secondary Outcome
Title Change From Baseline in Pain Interference "Pain Interfered With Walking Ability" (BPI Item 9c) at Week 24
Hide Description Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9c "pain interfered with walking ability" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with walking ability".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.1  (2.75) -1.2  (2.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.769
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.06
Confidence Interval 95%
-0.49 to 0.36
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
32.Secondary Outcome
Title Change From Baseline in Pain Interference "Pain Interfered With Normal Work" (BPI Item 9d) at Week 24
Hide Description Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9d "pain interfered with normal work" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with normal work".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.3  (2.63) -1.4  (2.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.843
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.04
Confidence Interval 95%
-0.40 to 0.49
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
33.Secondary Outcome
Title Change From Baseline in Pain Interference "Pain Interfered With Relations With Other People" (BPI Item 9e) at Week 24
Hide Description Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9e "pain interfered with relations with other people" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with relations with other people".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.7  (2.92) -0.9  (2.75)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.977
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.01
Confidence Interval 95%
-0.45 to 0.44
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
34.Secondary Outcome
Title Change From Baseline in Pain Interference "Pain Interfered With Sleep" (BPI Item 9f) at Week 24
Hide Description Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9f "pain interfered with sleep" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with sleep".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.4  (2.76) -1.5  (3.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.977
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.01
Confidence Interval 95%
-0.47 to 0.49
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
35.Secondary Outcome
Title Change From Baseline in Pain Interference "Pain Interfered With Enjoyment of Life" (BPI Item 9g) at Week 24
Hide Description Change from baseline in pain interference was assessed using the BPI questionnaire, specifically BPI item 9g "pain interfered with enjoyment of life" at week 24. Scores could have ranged from 0 to 10, where 0 = does not interfere to 10 = completely interferes. Negative change from baseline scores indicate improvement in "pain interfered with enjoyment of life".
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.2  (2.91) -1.3  (3.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.902
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.03
Confidence Interval 95%
-0.51 to 0.45
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
36.Secondary Outcome
Title Change From Baseline in BPI Pain Severity, Relief and Interference Scores (Extension Phase)
Hide Description Change from baseline in pain severity, pain relief, and pain interference was assessed using the BPI questionnaire at week 52. BPI items 3 to 6, score range 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine; BPI items 9a to 9g, score range from 0 to 10, where 0 = does not interfere and 10 = completely interferes. Negative change from baseline scores indicate improvement in pain severity and pain interference. BPI item 8, score range from 0 to 100, where 0 = no relief and 100 = complete relief. Positive change from baseline scores indicate improvement in pain relief.
Time Frame baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Pain severity, BPI items 3 to 6 -2.4  (1.67) -2.4  (2.13)
Pain relief, BPI item 8 17.7  (26.36) 23.6  (25.46)
Pain right now, BPI item 6 -2.9  (2.07) -2.8  (2.16)
Pain at its worst, BPI item 3 -2.8  (2.07) -2.4  (2.29)
Pain at its least, BPI item 4 -1.9  (2.14) -2.3  (2.59)
Average pain, BPI item 5 -2.6  (1.78) -2.6  (2.21)
Pain interfered general activity, BPI item 9a -2.5  (2.28) -2.6  (2.40)
Pain interfered mood, BPI item 9b -2.3  (2.42) -2.7  (3.12)
Pain interfered walking ability, BPI item 9c -2.3  (2.10) -2.5  (2.89)
Pain interfered normal work, BPI item 9d -2.9  (2.64) -3.2  (2.63)
Pain interfered relation other people, BPI item 9e -1.6  (2.56) -1.9  (3.34)
BPI pain interfered sleep, BPI item 9f -2.4  (2.61) -3.0  (3.02)
BPI pain interfered enjoyment of life, BPI item 9g -2.4  (2.63) -2.6  (3.32)
37.Secondary Outcome
Title Change From Baseline in Sleep Quality (MOS Index I) at Week 4
Hide Description Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items; MOS sleep scale index I (average of item 1, 3, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-10.6  (17.61) -8.7  (18.83)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.169
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.36
Confidence Interval 95%
-5.74 to 1.02
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
38.Secondary Outcome
Title Change From Baseline in Sleep Quality (MOS Index II) at Week 4
Hide Description Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 4. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-10.5  (16.40) -9.0  (17.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.245
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.89
Confidence Interval 95%
-5.09 to 1.31
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
39.Secondary Outcome
Title Change From Baseline in Sleep Quality (MOS Index II) at Week 24
Hide Description Change from baseline in sleep quality was assessed using the sleep subscales of the MOS questionnaire, which consists of 12 items. MOS index II (average of items 1, 3, 4, 5, 6, 7, 8, 9, and 12) was assessed at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep quality.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-8.9  (17.28) -6.5  (16.73)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.64
Confidence Interval 95%
-5.51 to 0.23
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
40.Secondary Outcome
Title Change From Baseline in Sleep Quality, Sleep Disturbance at Week 24
Hide Description Change from baseline in sleep quality (sleep disturbance) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep disturbance.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-13.1  (22.77) -11.7  (22.95)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.297
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.03
Confidence Interval 95%
-5.85 to 1.80
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
41.Secondary Outcome
Title Change From Baseline in Sleep Quality, Snoring at Week 24
Hide Description Change from baseline in sleep quality (snoring) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in snoring.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.0  (22.04) -4.1  (21.93)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.205
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.41
Confidence Interval 95%
-1.32 to 6.14
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
42.Secondary Outcome
Title Change From Baseline in Sleep Quality, Sleep Shortness of Breath or Headache at Week 24
Hide Description Change from baseline in sleep quality (sleep shortness of breath or headache) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep shortness of breath or headache.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-5.3  (28.44) -0.1  (24.27)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.107
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -3.35
Confidence Interval 95%
-7.43 to 0.73
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
43.Secondary Outcome
Title Change From Baseline in Sleep Quality, Sleep Adequacy at Week 24
Hide Description Change from baseline in sleep quality (sleep adequacy) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep adequacy.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
9.1  (28.10) 7.3  (26.63)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.475
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 1.60
Confidence Interval 95%
-2.80 to 6.00
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
44.Secondary Outcome
Title Change From Baseline in Sleep Quality, Sleep Somnolence at Week 24
Hide Description Change from baseline in sleep quality (sleep somnolence) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = best sleep quality and 100 = worst sleep quality. Negative change from baseline scores indicate improvement in sleep somnolence.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-1.6  (21.70) 3.0  (20.91)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -4.16
Confidence Interval 95%
-7.67 to -0.65
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
45.Secondary Outcome
Title Change From Baseline in Sleep Quality, Sleep Quantity at Week 24
Hide Description Change from baseline in sleep quality (sleep quantity) was assessed using the MOS questionnaire at week 24. Score range 0 to 100, where 0 = worst sleep quality and 100 = best sleep quality. Positive change from baseline scores indicate improvement in sleep quantity.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.4  (1.86) 0.5  (1.51)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.880
Comments 0.05 two-sided test
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.02
Confidence Interval 95%
-0.30 to 0.26
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
46.Secondary Outcome
Title Number of Subjects Indicating That They Had Optimal Sleep at Week 24
Hide Description Number of subjects indicating that they had optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 24. Optimal sleep was defined as 7 to 8 hours sleep per night.
Time Frame baseline and week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 249 242
Measure Type: Number
Unit of Measure: Subjects
Yes 83 71
No 166 171
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.320
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
47.Secondary Outcome
Title Change From Baseline in Sleep Quality at Week 52
Hide Description Change from baseline in sleep quality was assessed using the MOS questionnaire at week 52. Score range 0 to 100. For disturbance, snoring, shortness of breath or headache, and somnolence, 0 = best sleep quality and 100 = worst sleep quality; negative change from baseline scores indicate improvement in sleep quality for these measures. For adequacy and quantity, 0 = worst sleep quality and 100 = best sleep quality; positive change from baseline scores indicate improvement in sleep quality for these measures.
Time Frame baseline and week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
MOS sleep disturbance -17.6  (22.44) -20.1  (23.17)
MOS snoring -2.5  (23.01) -4.7  (23.86)
MOS sleep shortness of breath or headache -8.4  (19.89) -7.8  (21.94)
MOS sleep adequacy 12.3  (27.06) 11.9  (30.74)
MOS sleep somnolence -6.5  (20.49) 1.8  (21.54)
MOS sleep quantity 0.5  (2.27) 0.5  (1.25)
48.Secondary Outcome
Title Number of Subjects Indicating Optimal Sleep at Week 52
Hide Description Number of subjects who experienced optimal sleep was assessed based on the number of hours of sleep reported on the MOS questionnaire at week 52. Optimal sleep was defined as 7-8 hours sleep per night.
Time Frame week 52
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 55 49
Measure Type: Number
Unit of Measure: Subjects
Yes 27 19
No 28 30
49.Secondary Outcome
Title Change From Baseline in Subject Diary Mean Pain Evening, Morning, and All Day Scores at Week 24
Hide Description Change from baseline to week 24 in subject diary evening, morning and all day mean pain scores for pain right now, at its worst, at its least, and average. Subjects rated the severity of pain on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain scores.
Time Frame baseline and week 24
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Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Evening worst pain -2.2  (2.32) -2.1  (2.31)
Evening least pain -1.6  (2.28) -1.4  (2.36)
Evening average pain -2.0  (2.12) -1.8  (2.22)
Morning worst pain -1.9  (2.38) -2.1  (2.34)
Morning least pain -1.5  (2.44) -1.2  (2.44)
Morning average pain -1.7  (2.20) -1.8  (2.30)
All day worst pain -2.1  (2.11) -2.1  (2.09)
All day least pain -1.5  (2.21) -1.3  (2.22)
All day average pain -1.8  (2.00) -1.8  (2.08)
All day pain right now -2.1  (2.05) -2.0  (2.20)
50.Secondary Outcome
Title Change From Baseline in Subject Diary Mean Pain Score for "Pain at Its Worst" From Morning to Evening at Weeks 4, 8, 12, 16, 20, and 24
Hide Description Change from baseline in subject diary mean pain score "pain at its worst" from morning to evening at weeks 4, 8, 12, 16, 20, and 24. Subjects rated the severity of "pain right now" on a 10 point numeric scale, with 0 being the least pain and 10 being the most pain. Negative change from baseline scores indicate improvement in subject diary mean pain score "pain at its worst".
Time Frame baseline and weeks 4, 8, 12, 16, 20, and 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Baseline 0.7  (1.93) 0.4  (1.88)
Week 4 0.5  (1.30) 0.4  (1.22)
Week 8 0.4  (1.23) 0.4  (1.42)
Week 12 0.3  (1.23) 0.3  (1.26)
Week 16 0.2  (1.08) 0.2  (1.28)
Week 20 0.3  (1.13) 0.2  (1.14)
Week 24 0.3  (1.23) 0.3  (1.07)
51.Secondary Outcome
Title Number of Subjects With Dose Escalation at Week 4 (ITT Population)
Hide Description The number of subjects with dose increase in study medication was assessed at week 4.
Time Frame week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Measure Type: Number
Unit of Measure: Subjects
Yes 175 166
No 79 84
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.575
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
52.Secondary Outcome
Title Number of Subjects With Dose Escalation at Week 24 (ITT Population)
Hide Description The number of subjects with dose increase in study medication was assessed at week 24.
Time Frame week 24
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 203 182
Measure Type: Number
Unit of Measure: Subjects
Yes 146 145
No 57 37
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.807
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
53.Secondary Outcome
Title Change From Baseline in Quality of Life (QoL) "Bodily Pain" at Week 4
Hide Description Change from baseline in QoL was assessed using the Short Form (SF)-36 QoL questionnaire, specifically the SF-36 bodily pain index. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in bodily pain.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
13.7  (18.10) 16.7  (18.43)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.118
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.61
Confidence Interval 95%
-5.88 to 0.67
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
54.Secondary Outcome
Title Change From Baseline in QoL "General Health Perceptions" at Week 4
Hide Description Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 general health perceptions score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in general health perceptions.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
3.9  (14.43) 5.0  (16.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.956
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.08
Confidence Interval 95%
-3.08 to 2.91
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
55.Secondary Outcome
Title Change From Baseline in QoL "Health Transition" at Week 4
Hide Description Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 health transition score at week 4. Scores could range from 0 to 100, with higher scores indicating a better QoL. Positive change from baseline scores indicate improvement in health transition.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.4  (1.08) -0.5  (0.99)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.299
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.09
Confidence Interval 95%
-0.08 to 0.26
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
56.Secondary Outcome
Title Change From Baseline in QoL "Mental Health" at Week 4
Hide Description Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 mental health score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in mental health score.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
6.2  (15.76) 6.6  (17.17)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.471
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.13
Confidence Interval 95%
-4.20 to 1.95
Estimation Comments Mean difference calculated: hydromorphone minus oxymorphone
57.Secondary Outcome
Title Change From Baseline in QoL "Physical Functioning" at Week 4
Hide Description Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 physical functioning score at week 4. Scores could range from 0 to 100, with high scores indicating a better QoL. Positive change from baseline scores indicate improvement in physical functioning.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
8.7  (17.05) 5.4  (16.80)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.025
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.84
Confidence Interval 95%
0.48 to 7.19
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
58.Secondary Outcome
Title Change From Baseline in QoL "Role Emotional" at Week 4
Hide Description Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 "role emotional" score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in "role emotional".
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
9.9  (43.25) 4.7  (48.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.556
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 2.40
Confidence Interval 95%
-5.61 to 10.42
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
59.Secondary Outcome
Title Change From Baseline in QoL "Role Physical" at Week 4
Hide Description Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 role physical score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in role physical.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
13.2  (36.84) 16.9  (36.08)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.551
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.12
Confidence Interval 95%
-9.11 to 4.88
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
60.Secondary Outcome
Title Change From Baseline in QoL "Social Functioning" at Week 4
Hide Description Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 social functioning score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in social functioning.
Time Frame baseline and week 4
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population (all randomized subjects who took the study medication at least once, excluding subjects who had no post-baseline efficacy data)
Arm/Group Title OROS Hydromorphone HCl Oxycodone
Hide Arm/Group Description:
Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
Overall Number of Participants Analyzed 254 250
Mean (Standard Deviation)
Unit of Measure: Units on a scale
10.5  (25.33) 12.9  (26.39)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection OROS Hydromorphone HCl, Oxycodone
Comments Exploratory comparison
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.207
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.98
Confidence Interval 95%
-7.63 to 1.66
Estimation Comments Mean difference calculated: hydromorphone minus oxycodone
61.Secondary Outcome
Title Change From Baseline in QoL "Vitality" at Week 4
Hide Description Change from baseline in QoL was assessed using the SF-36 QoL questionnaire, specifically SF-36 vitality score at week 4. Scores could range from 0 to 100, with a high score indicating a better QoL. Positive change from baseline scores indicate improvement in vitality.
Time Frame baseline and week 4
Hide Outcome Measure Data