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Tapentadol IR vs Oxycodone IR vs Placebo in Acute Pain From Vertebral Compression Fracture Associated With Osteoporosis

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ClinicalTrials.gov Identifier: NCT00771758
Recruitment Status : Completed
First Posted : October 13, 2008
Results First Posted : April 7, 2011
Last Update Posted : May 9, 2014
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Ortho-McNeil Janssen Scientific Affairs, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Back Pain
Interventions Drug: oxycodone IR
Drug: placebo
Drug: tapentadol IR
Enrollment 108
Recruitment Details

The recruitment period for this outpatient, multicenter study occurred between August 28, 2008 and December 9, 2009.

The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects.

Pre-assignment Details The study consisted of a screening/randomization period (one day) and a double blind active treatment period (10 days).
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg. 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg. 1 capsule every 4 - 6 hr as needed for up to 10 days
Period Title: Overall Study
Started 44 43 21
Completed 36 31 19
Not Completed 8 12 2
Reason Not Completed
Adverse Event             2             8             1
Lack of Efficacy             0             2             1
Lost to Follow-up             1             0             0
Protocol Violation             1             0             0
Withdrawal by Subject             1             0             0
Other             3             2             0
Arm/Group Title Tapentadol IR Oxycodone IR Placebo Total
Hide Arm/Group Description 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg. 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg. 1 capsule every 4 - 6 hr as needed for up to 10 days Total of all reporting groups
Overall Number of Baseline Participants 44 43 21 108
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 43 participants 21 participants 108 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
15
  34.1%
11
  25.6%
7
  33.3%
33
  30.6%
>=65 years
29
  65.9%
32
  74.4%
14
  66.7%
75
  69.4%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 44 participants 43 participants 21 participants 108 participants
69.8  (12.28) 69.3  (13.26) 69.6  (12.36) 69.5  (12.58)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 44 participants 43 participants 21 participants 108 participants
Female
30
  68.2%
32
  74.4%
14
  66.7%
76
  70.4%
Male
14
  31.8%
11
  25.6%
7
  33.3%
32
  29.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
USA Number Analyzed 44 participants 43 participants 21 participants 108 participants
44 43 21 108
1.Primary Outcome
Title Sum of Pain Intensity Difference Over 3 Days (SPID72)
Hide Description

Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.

The study was terminated prematurely due to slow enrollment after 108 of 600 subjects enrolled. Valid statistical conclusions cannot be made due to the low number of subjects.

Time Frame 3 Days (72 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
The modified Intent-to-Treat(mITT) population was defined as all randomized patients who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
139.0  (132.57) 129.4  (115.76) 114.2  (99.87)
2.Secondary Outcome
Title 30% Responder Rate on Day 3.
Hide Description The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the Interactive Voice Response (IVR) system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Measure Type: Number
Unit of Measure: percentage of participants
36.1 39.0 50.0
3.Secondary Outcome
Title 50% Responder Rate on Day 3.
Hide Description The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM).
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Measure Type: Number
Unit of Measure: percentage of participants
25.0 24.4 25.0
4.Secondary Outcome
Title 30% Responder Rate on Day 5.
Hide Description The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Measure Type: Number
Unit of Measure: percentage of participants
44.4 48.8 35.0
5.Secondary Outcome
Title 50% Responder Rate on Day 5.
Hide Description The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 5 (average of Day 5 PM and Day 6 AM).
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Measure Type: Number
Unit of Measure: percentage of participants
25.0 26.8 25.0
6.Secondary Outcome
Title 30% Responder Rate on Day 10.
Hide Description The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Measure Type: Number
Unit of Measure: percentage of participants
52.8 39.0 55.0
7.Secondary Outcome
Title 50% Responder Rate on Day 10.
Hide Description The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 10 (average of Day 9 PM and Day 10 AM).
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Measure Type: Number
Unit of Measure: percentage of participants
30.6 26.8 30.0
8.Secondary Outcome
Title Sum of Pain Intensity Difference Over 2 Days (SPID48)
Hide Description Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.
Time Frame 2 Days (48 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
82.1  (92.13) 86.5  (69.46) 67.1  (66.66)
9.Secondary Outcome
Title Sum of Pain Intensity Difference Over 5 Days (SPID120)
Hide Description Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID120 was calculated as the time-weighted Sum of PID scores over 120 hours. The range of SPID120 is from -1200 to 1200. The higher value in SPID indicates greater pain relief.
Time Frame 5 Days (120 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
252.7  (208.91) 227.1  (200.66) 198.4  (177.76)
10.Secondary Outcome
Title Sum of Pain Intensity Difference Over 10 Days
Hide Description Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. Sum of Pain Intensity Difference Over 10 Days was calculated as the time-weighted Sum of PID scores up to Day 10, 8 AM. The range is from -2160 to 2160. The higher value in Sum of Pain Intensity Difference indicates greater pain relief.
Time Frame 10 Days (216 Hours)
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
505.0  (373.00) 422.9  (382.78) 389.9  (343.31)
11.Secondary Outcome
Title Total Pain Relief (TOTPAR) Over 2 Days
Hide Description Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.
Time Frame 2 Days (48 Hours)
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
84.7  (38.79) 92.3  (42.42) 89.5  (44.55)
12.Secondary Outcome
Title Total Pain Relief (TOTPAR) Over 3 Days
Hide Description Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.
Time Frame 3 Days (72 Hours)
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
126.5  (57.98) 138.3  (61.02) 125.8  (66.12)
13.Secondary Outcome
Title Total Pain Relief (TOTPAR) Over 5 Days
Hide Description Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 120. The range of TOTPAR over 5 days is from 0 to 480. A higher value in TOTPAR indicated greater pain relief.
Time Frame 5 Days (120 Hours)
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
216.8  (97.36) 232.6  (102.87) 220.7  (106.00)
14.Secondary Outcome
Title Total Pain Relief (TOTPAR) Over 10 Days
Hide Description Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 10, 8 AM. The range of TOTPAR over 10 days is from 0 to 864. A higher value in TOTPAR indicated greater pain relief.
Time Frame 10 Days (216 Hours)
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
378.8  (167.27) 414.4  (190.38) 391.7  (184.35)
15.Secondary Outcome
Title Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 2 Days
Hide Description The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.
Time Frame 2 Days
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
168.6  (109.56) 178.9  (97.04) 158.9  (87.52)
16.Secondary Outcome
Title Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 3 Days
Hide Description The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.
Time Frame 3 Days
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
265.5  (162.13) 267.7  (152.74) 240.0  (130.29)
17.Secondary Outcome
Title Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 5 Days
Hide Description The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 5 days is from -1200 to 1680. A higher value in SPRID indicated greater pain relief.
Time Frame 5 Days
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
469.5  (270.72) 459.7  (266.29) 419.1  (229.41)
18.Secondary Outcome
Title Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) Over 10 Days
Hide Description The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 10 days is from -2160 to 3024. A higher value in SPRID indicated greater pain relief.
Time Frame 10 Days
Hide Outcome Measure Data
Hide Analysis Population Description
modified Intent-to-Treat (mITT) population defined as all randomized participants who took at least one dose of study drug and had a baseline pain intensity assessment via the IVR system with score ≥5 on an 11-point NRS.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 36 41 20
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
883.8  (482.19) 837.3  (509.07) 781.7  (442.17)
19.Secondary Outcome
Title Change From Baseline in Physical Performance: Measured Walk - Change in Distance Walked in the End of Study
Hide Description The participants were assessed whether were able to walk for 4 meters at each visit. For those subjects who were unable to walk 4 meters, the distance walked would be recorded. For those completed the walk, 4 meters were recorded. The change in distance walked at the end of study was derived using the distance walked at baseline minus the distance walked at the end of study (Day 10). The range of change in distance walked is from -4 to 4. A negative value indicated better performance.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat subjects.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Mean (Standard Deviation)
Unit of Measure: meters
-0.1  (0.32) 0.4  (2.31) 0.0  (0.00)
20.Secondary Outcome
Title Change From Baseline in Physical Performance: Measured Walk - Change in Time Taken Per Meter to Take Walk in the End of Study
Hide Description The time for the subject to walk for 4 meters was measured at baseline and the end of study. Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat subjects.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Mean (Standard Deviation)
Unit of Measure: seconds
0.6  (2.10) 3.5  (18.24) 0.6  (1.72)
21.Secondary Outcome
Title Change From Baseline in Physical Performance: Chair Stand - Change in Number of Chair Stands Completed in the End of Study
Hide Description The participants were assessed whether were able to rise from a chair 5 times at each visit. For those subjects who were unable to complete all 5 rises, the number of rises would be recorded. For those completed the 5 rises, 5 were recorded. The change in number of chair stands at the end of study was derived using the number of chair stands at baseline minus the number of chair stands at the end of study (Day 10). The range of change in number of chair stands is from -5 to 5. A negative value indicated better performance.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat subjects.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Mean (Standard Deviation)
Unit of Measure: chair stands
-0.1  (0.23) -0.0  (0.16) 0.0  (0.00)
22.Secondary Outcome
Title Change From Baseline in Physical Performance: Chair Stand - Change in Time Taken to Complete Chair Stands in the End of Study
Hide Description

The time for the subject to rise from a chair 5 times was measured at baseline and the end of study.

Change = baseline - end of study. For the change in each treatment group, only subjects who were assessed at both baseline and end of study were summarized. A positive value of Change indicated performance improved.

Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat subjects.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Mean (Standard Deviation)
Unit of Measure: second
3.1  (9.51) 3.6  (11.08) 2.6  (9.22)
23.Secondary Outcome
Title Summary of Subject Satisfaction With Treatment on Day 2
Hide Description Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.
Time Frame Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.5  (1.58) 3.0  (1.69) 3.6  (2.23)
24.Secondary Outcome
Title Summary of Subject Satisfaction With Treatment on Day 3
Hide Description Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.3  (1.69) 2.8  (1.71) 3.3  (1.70)
25.Secondary Outcome
Title Summary of Subject Satisfaction With Treatment on Day 5
Hide Description Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.5  (1.72) 2.6  (1.27) 3.7  (1.60)
26.Secondary Outcome
Title Summary of Subject Satisfaction With Treatment on Day 10
Hide Description Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
3.3  (1.94) 2.5  (1.38) 3.1  (1.61)
27.Secondary Outcome
Title Sleep Quality - Shift From Baseline to End of Study (Tapentadol IR)
Hide Description Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was "Please rate the overall quality of your sleep last night.", which was administered via Interactive Voice Response (IVR) system in the morning.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.
Arm/Group Title Excellent - End of Study Good - End of Study Fair - End of Study Poor - End of Study Missing - End of Study Baseline Total
Hide Arm/Group Description:
Tapentadol IR
Tapentadol IR
Tapentadol IR
Tapentadol IR
Tapentadol IR
Tapentadol IR
Overall Number of Participants Analyzed 12 12 13 2 2 41
Measure Type: Number
Unit of Measure: participants
Excellent - Baseline 0 0 0 0 0 0
Good - Baseline 5 4 2 0 1 12
Fair - Baseline 2 8 8 1 0 19
Poor - Baseline 5 0 3 1 1 10
Missing - Baseline 0 0 0 0 0 0
End of Study Total 12 12 13 2 2 41
28.Secondary Outcome
Title Sleep Quality - Shift From Baseline to End of Study (Oxycodone IR)
Hide Description Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was "Please rate the overall quality of your sleep last night.", which was administered via IVR system in the morning.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.
Arm/Group Title Excellent - End of Study Good - End of Study Fair - End of Study Poor - End of Study Missing - End of Study Baseline Total
Hide Arm/Group Description:
Oxycodone IR
Oxycodone IR
Oxycodone IR
Oxycodone IR
Oxycodone IR
Oxycodone IR
Overall Number of Participants Analyzed 9 13 12 6 3 43
Measure Type: Number
Unit of Measure: participants
Excellent - Baseline 0 0 0 0 0 0
Good - Baseline 1 6 2 0 1 10
Fair - Baseline 8 6 7 3 0 24
Poor - Baseline 0 1 3 3 1 8
Missing - Baseline 0 0 0 0 1 1
End of Study Total 9 13 12 6 3 43
29.Secondary Outcome
Title Sleep Quality - Shift From Baseline to End of Study (Placebo)
Hide Description Sleep Quality was assessed by a 4-point numeric scale (1=excellent, 2=good, 3=fair, and 4=poor). The sleep question was "Please rate the overall quality of your sleep last night.", which was administered via IVR system in the morning.
Time Frame 10 days
Hide Outcome Measure Data
Hide Analysis Population Description
Placebo arm of Intent-to-Treat population. Shift table from baseline to end of study. Percentages were based on the number of intent-to-treat subjects within a screening category.
Arm/Group Title Excellent - End of Study Good - End of Study Fair - End of Study Poor - End of Study Baseline Total
Hide Arm/Group Description:
Placebo
Placebo
Placebo
Placebo
Placebo
Overall Number of Participants Analyzed 4 4 11 2 21
Measure Type: Number
Unit of Measure: participants
Excellent - Baseline 0 0 0 0 0
Good - Baseline 2 0 3 0 5
Fair - Baseline 1 2 6 0 9
Poor - Baseline 1 2 2 2 7
Missing - Baseline 0 0 0 0 0
End of Study Total 4 4 11 2 21
30.Secondary Outcome
Title Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 2
Hide Description Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.
Time Frame Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percentage of participants
14.7 8.6 11.1
31.Secondary Outcome
Title Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 3
Hide Description Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percentage of participants
19.4 13.9 15.8
32.Secondary Outcome
Title Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 5
Hide Description Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percentage of participants
25.0 14.8 11.1
33.Secondary Outcome
Title Summary of Functionality: Dressing - Proportion With at Least 2 Points of Improvement From Baseline to Day 10
Hide Description Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percentage of participants
28.6 25.0 7.1
34.Secondary Outcome
Title Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 2
Hide Description Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.
Time Frame Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percentage of participants
11.8 14.3 11.1
35.Secondary Outcome
Title Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 3
Hide Description Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percentage of participants
16.7 19.4 10.5
36.Secondary Outcome
Title Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 5
Hide Description Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percentage of participants
15.6 14.8 5.9
37.Secondary Outcome
Title Summary of Functionality: Bath/Shower - Proportion With at Least 2 Points of Improvement From Baseline to Day 10
Hide Description Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percentage of participants
21.4 20.8 7.1
38.Secondary Outcome
Title Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 2
Hide Description Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.
Time Frame Day 2
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percentage of participants
20.6 14.3 0
39.Secondary Outcome
Title Summary of Functionality: Chair - Proportion With at Least 2 Point of Improvement From Baseline to Day 3
Hide Description Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percentage of participants
16.7 8.3 10.5
40.Secondary Outcome
Title Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 5
Hide Description Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.
Time Frame Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percentage of participants
18.8 7.4 5.6
41.Secondary Outcome
Title Summary of Functionality: Chair - Proportion With at Least 2 Points of Improvement From Baseline to Day 10
Hide Description Level of functionality assessed using a 5-point scale where 0=no difficulty and 4=impossible without help.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percentage of participants
28.6 8.3 14.3
42.Secondary Outcome
Title Patient Global Impression of Change (PGIC) at End of Study
Hide Description Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percenatage of participants
Very much improved 17.1 9.3 9.5
Much improved 24.4 34.9 23.8
Minimally improved 26.8 34.9 23.8
No change 26.8 11.6 28.6
Minimally worse 0 4.7 4.8
Much worse 0 2.3 0
Very much worse 0 0 4.8
43.Secondary Outcome
Title Clinician Global Impression of Change (CGIC) at End of Study
Hide Description Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percenatage of participants
Very much improved 19.5 7.0 14.3
Much improved 29.3 39.5 23.8
Minimally improved 19.5 34.9 33.3
No change 26.8 9.3 19.0
Minimally worse 0 4.7 4.8
Much worse 0 2.3 0
Very much worse 0 0 4.8
44.Secondary Outcome
Title Summary of Clinician Ease-of-Care at the End of Study: Time Comsuming
Hide Description The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = “not at all” to 5=“a very great deal.”
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percent of participants
Not at all 51.2 51.2 47.6
A little bit 19.5 16.3 23.8
Somewhat 12.2 16.3 19.0
Quite a bit 12.2 9.3 4.8
A great deal 2.4 4.7 4.8
A very great deal 0 0 0
45.Secondary Outcome
Title Summary of Clinician Ease-of-Care at the End of Study: Bothersome
Hide Description The Clinician Ease-of-Care was defined on a 6-point scale, where 0 = "not at all" to 5="a very great deal."
Time Frame Day 10
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to Treat population.
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description:
50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg.
5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg.
1 capsule every 4 - 6 hr as needed for up to 10 days
Overall Number of Participants Analyzed 41 43 21
Measure Type: Number
Unit of Measure: percent of participants
Not at all 56.1 53.5 76.2
A little bit 17.1 18.6 9.5
Somewhat 14.6 9.3 4.8
Quite a bit 7.3 14.0 4.8
A great deal 2.4 2.3 4.8
A very great deal 0 0 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tapentadol IR Oxycodone IR Placebo
Hide Arm/Group Description 50 or 75 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 450 mg. 5 or 10 mg capsule every 4 - 6 hr as needed for up to 10 days; maximum daily dose 60 mg. 1 capsule every 4 - 6 hr as needed for up to 10 days
All-Cause Mortality
Tapentadol IR Oxycodone IR Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tapentadol IR Oxycodone IR Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/44 (2.27%)   1/43 (2.33%)   0/21 (0.00%) 
Cardiac disorders       
Cardiac Failure Congestive * 1  0/44 (0.00%)  1/43 (2.33%)  0/21 (0.00%) 
Infections and infestations       
Cellulitis * 1  0/44 (0.00%)  1/43 (2.33%)  0/21 (0.00%) 
Injury, poisoning and procedural complications       
Accidental Overdose * 1  1/44 (2.27%)  0/43 (0.00%)  0/21 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tapentadol IR Oxycodone IR Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   23/44 (52.27%)   29/43 (67.44%)   6/21 (28.57%) 
Gastrointestinal disorders       
Nausea * 1  15/44 (34.09%)  19/43 (44.19%)  1/21 (4.76%) 
Vomiting * 1  12/44 (27.27%)  19/43 (44.19%)  4/21 (19.05%) 
Constipation * 1  1/44 (2.27%)  3/43 (6.98%)  1/21 (4.76%) 
Metabolism and nutrition disorders       
Anorexia * 1  1/44 (2.27%)  3/43 (6.98%)  1/21 (4.76%) 
Nervous system disorders       
Dizziness * 1  8/44 (18.18%)  7/43 (16.28%)  0/21 (0.00%) 
Headache * 1  4/44 (9.09%)  2/43 (4.65%)  0/21 (0.00%) 
Somnolence * 1  4/44 (9.09%)  5/43 (11.63%)  2/21 (9.52%) 
Skin and subcutaneous tissue disorders       
Pruritus * 1  0/44 (0.00%)  3/43 (6.98%)  0/21 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Insufficient number of participants enrolled to meet proposed sample size, so that statistical inferences could not be made.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director of Clinical Development, Pain
Organization: Ortho-McNeil Janssen Scientific Affair, LLC.
Phone: (908)927-5465
Layout table for additonal information
Responsible Party: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00771758     History of Changes
Other Study ID Numbers: CR015064
KF5503/40
First Submitted: October 10, 2008
First Posted: October 13, 2008
Results First Submitted: December 8, 2010
Results First Posted: April 7, 2011
Last Update Posted: May 9, 2014