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Trial record 98 of 663 for:    OXYCODONE

Tapentadol Prolonged Release (PR) Versus Oxycodone/Naloxone Prolonged Release in Severe Chronic Low Back Pain With a Neuropathic Component.

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ClinicalTrials.gov Identifier: NCT01838616
Recruitment Status : Completed
First Posted : April 24, 2013
Results First Posted : June 8, 2015
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Grünenthal GmbH

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Back Pain
Low Back Pain
Neuropathic Pain
Interventions Drug: Tapentadol Prolonged Release
Drug: Oxycodone/Naloxone Prolonged Release
Enrollment 367
Recruitment Details The trial started on 22 Mar 2013 with the enrollment of the first participant and was completed on 28 Jan 2014 when the last subject completed the last follow-up examination according to the protocol.
Pre-assignment Details

367 participants signed informed consent. 89 participants did not meet the inclusion/exclusion criteria, 16 participants withdrew and 4 participants left the trial for other reasons.

Participants randomized to oxycodone/naloxone PR could be switched to tapentadol PR treatment in the pick-up arm of the trial.

Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Period Title: Titration Period
Started 130 128
No Post Baseline Pain Intensity Values 0 2
Major Protocol Deviations 13 16
Switched to Pick-up Arm 0 43
Full Analysis Set 130 128
Per Protocol Set 117 112
Completed 100 62
Not Completed 30 66
Reason Not Completed
Adverse Event             18             48
Lack of Efficacy             5             12
Withdrawal by Subject             5             5
Technical problems             1             0
Not specified             1             0
Protocol Violation             0             1
Period Title: Continuation Period
Started 100 62
Switched to Pick-up Arm 0 7
Completed 86 48
Not Completed 14 14
Reason Not Completed
Lack of Efficacy             3             5
Adverse Event             8             4
Protocol Violation             2             0
Lost to Follow-up             1             0
Withdrawal by Subject             0             4
Technical problems             0             1
Period Title: Pick-up Arm
Started 50 [1] 0
Full Analysis Set 49 0
Completed 35 [2] 0
Not Completed 15 0
Reason Not Completed
Lack of Efficacy             4             0
Adverse Event             9             0
Withdrawal by Subject             1             0
Technical problems             1             0
[1]
Switch to Tapentadol (PR) after Oxycodone/Naloxone (PR) treatment discontinuation.
[2]
Participants completed the tapentadol pick-up arm after initially on oxycodone/naloxone PR treatment
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release Total
Hide Arm/Group Description All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. Total of all reporting groups
Overall Number of Baseline Participants 130 128 258
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 130 participants 128 participants 258 participants
58.1  (11.48) 58.4  (12.23) 58.2  (11.84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 128 participants 258 participants
Female
77
  59.2%
84
  65.6%
161
  62.4%
Male
53
  40.8%
44
  34.4%
97
  37.6%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 130 participants 128 participants 258 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
White
130
 100.0%
128
 100.0%
258
 100.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 128 participants 258 participants
Spain 20 19 39
Austria 8 9 17
Germany 102 100 202
Dermatol pain present  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 128 participants 258 participants
121 111 232
Lumbar radiculopathy  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 128 participants 258 participants
76 75 151
Duration of pain [months]  
Median (Full Range)
Unit of measure:  Months
Number Analyzed 130 participants 128 participants 258 participants
61.5
(4 to 552)
72
(3 to 504)
70.5
(3 to 552)
Height  
Mean (Standard Deviation)
Unit of measure:  Centimeters
Number Analyzed 130 participants 128 participants 258 participants
168.9  (11.00) 167.7  (9.71) 168.3  (10.38)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kilogram
Number Analyzed 130 participants 128 participants 258 participants
85.3  (18.23) 81.6  (18.43) 83.5  (18.39)
painDETECT   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 130 participants 128 participants 258 participants
painDETECT positive 96 97 193
painDETECT unclear 33 27 60
painDETECT negative 1 4 5
[1]
Measure Description: The painDETECT questionnaire was used to determine the possibility of the presence of a neuropathic pain component. It is a participant completed questionnaire. A total score is calculated. Participants with a score between 0 and 12 are scored as being "negative" (no neuropathic pain component). Value between 19 and 38 as being "positive" (presence of neuropathic component)". Values from 13 to 18 are scored as being "unclear". Participants being treated with a stable regimen of centrally acting co-analgesics at baseline were permitted if the score was at least 9.
1.Primary Outcome
Title Change in the Average Pain Intensity Score on an 11-point Numeric Rating Scale (NRS-3)
Hide Description For this pain assessment, the participant indicated the level of average pain experienced over the previous 3 days on an 11-point Numeric Rating Scale (NRS-3) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The value reported represents the change from the randomization visit (i.e., the last 3 days in the washout period prior to Investigational Medicinal Product initiation and titration) to the end of the continuation period (i.e., up to 9 weeks on the stable dose). The theoretical values range from -10 to 10. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (Baseline Visit).
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis was performed for the Per Protocol Set (PPS). Last Observation Carried Forward (LOCF).
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 117 112
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.7  (0.25) -2.7  (0.26)
2.Primary Outcome
Title Change in the Patient Assessment of Constipation Symptoms (PAC-SYM) Total Score
Hide Description The Constipation Assessment (PAC-SYM) is a 12-item self-report questionnaire that assessed the severity of symptoms of constipation. Participants were asked "How severe have each of these symptoms been in the last two weeks?" e.g. "Pain in your stomach". There are 3 subscales: 4 questions on abdominal symptoms, 3 on rectal symptoms and 5 on stool symptoms. Responses were rated on a 5-point Likert scale ranging from 0 (absence of symptom) to 4 (very severe symptoms). If the changes in the overall or subscale scores are positive then there is a worsening in symptoms associated with constipation. The change in the assessment of constipation symptoms (PAC-SYM) total score from the Randomization Visit to the Final Evaluation Visit. The PAC-SYM overall score is the sum of scores of all non-missing items divided by the number of non-missing items (if at least 6 items were non-missing).
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
The primary analysis was performed for the Per Protocol Set (PPS).
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 117 112
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.07  (0.060) 0.14  (0.062)
3.Secondary Outcome
Title Recalled Average Pain Intensity
Hide Description The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recalls the average pain intensity during the last 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”.
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 126
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.7  (1.04) 7.6  (0.95)
End of Continuation Period 3.9  (2.68) 4.8  (2.43)
4.Secondary Outcome
Title Change in Recalled Average Pain Intensity at the End of Treatment
Hide Description The recalled average pain intensity score on the NRS-3 was assessed using an 11-point Numeric Rating Scale (NRS), on this scale 0 indicates no pain and 10 indicates pain as bad as you can imagine. This scale recorded the average pain intensity recalled by the participant during the previous 3 days. The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your pain on average during the last 3 days (the last 72 hours prior to the visit)”. A negative sign indicates a decrease in pain from the start of treatment. The higher the absolute values, the greater the change since the start of treatment (baseline visit).
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 126
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.7  (0.24) -2.8  (0.24)
5.Secondary Outcome
Title Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg
Hide Description

Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve.

The participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic.

The recalled average pain intensity over the past 3 days for the pain radiating towards or into the leg was assessed by the participant using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.

Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 129 125
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.5  (1.25) 7.6  (1.05)
End of Continuation Period 3.7  (2.76) 4.7  (2.52)
6.Secondary Outcome
Title Change of Average Pain Intensity Over Three Days for Pain Radiating Towards or Into the Leg at the End of Treatment
Hide Description

Typical dermatomal pain was defined as being pain that radiates beyond the knee towards the foot (sciatica) or pain evoked by stretching of the sciatic nerve.

Therefore, the participant was asked to rate their pain intensity over the past 3 days with regards to this particular pain characteristic.

The recalled average pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.

A negative sign indicates that there was a decrease in the average pain radiating towards or into the leg.

Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 129 125
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.9  (0.25) -2.8  (0.25)
7.Secondary Outcome
Title Worst Pain Intensity Over the Past 24 Hours
Hide Description

The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.

The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit”

Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 129 125
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 8.1  (1.03) 8.0  (1.06)
End of Continuation Period 4.3  (2.73) 5.2  (2.50)
8.Secondary Outcome
Title Change in Worst Pain Intensity Over the Past 24 Hours at the End of Treatment
Hide Description

The recalled worst pain intensity during the last 24 hours was assessed using an 11-point Numeric rating scale, where 0 = no pain and 10 = pain as bad as you can imagine.

The participant was asked: “Please rate your pain intensity by assessing the one number that best describes your worst pain during the last 24 hours prior to the visit”.

A negative change indicates that the pain intensity decreased from the start of the trial.

Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 129 125
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-3.7  (0.25) -2.8  (0.25)
9.Secondary Outcome
Title painDETECT Final Assessment
Hide Description The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being “negative” (had no neuropathic pain component). A value between 19 and 38 was rated as being “positive” (neuropathic component present). Values from 13 to 18 were scored as being “unclear”. The theoretical range of change in this trial ranged from -38 to 15. A negative change indicated a decrease in their neuropathic component of pain.
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 124 115
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 22.3  (5.25) 22.5  (4.79)
End of Continuation Period 11.9  (7.76) 14.6  (7.37)
10.Secondary Outcome
Title Change in painDETECT Final Assessment at the End of Treatment
Hide Description The painDETECT was a participant completed questionnaire. The questionnaire consists of 14 questions in four domains. Based on these questions a final assessment score was calculated. The minimum score ranged from zero to a maximum of 38. Participants with a score between 0 and 12 were scored as being "negative" (had no neuropathic pain component). A value between 19 and 38 was rated as being "positive" (neuropathic component present). Values from 13 to 18 were scored as being "unclear". The theoretical range of change in this trial ranged from -38 to 15. A negative change indicated a decrease in their neuropathic component of pain.
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 124 115
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-10.8  (0.67) -7.9  (0.69)
11.Secondary Outcome
Title Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment
Hide Description In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale; from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 1.
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 125
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Overall Score 0.598  (0.1769) 0.612  (0.1445)
End Continuation Period Overall Score 0.251  (0.2344) 0.354  (0.2334)
Baseline Sub-Score Burning Pain 0.612  (0.2569) 0.634  (0.2279)
End Continuation Period Sub-Score Burning Pain 0.248  (0.2767) 0.337  (0.2758)
Baseline Sub-score pressing pain 0.595  (0.2523) 0.608  (0.1848)
End Continuation Period Sub-Score Pressing Pain 0.276  (0.2650) 0.375  (0.2645)
Baseline Sub-Score Paroxysmal Pain 0.638  (0.2312) 0.670  (0.1720)
End Continuation Period Sub-Score Paroxysmal Pain 0.269  (0.2716) 0.375  (0.2673)
Baseline Sub-Score Evoked Pain 0.555  (0.2536) 0.548  (0.2300)
End Continuation Period Sub-Score Evoked Pain 0.219  (0.2520) 0.321  (0.2554)
Baseline Sub-Score Pare/Dysesthesia 0.621  (0.2292) 0.642  (0.1809)
End Continuation Period Sub-Score Pare/Dysesthesia 0.260  (0.2656) 0.372  (0.2615)
12.Secondary Outcome
Title Change in Neuropathic Pain Symptom Inventory (NPSI) Sub-scores and Overall Score Assessment at the End of Treatment
Hide Description In the Neuropathic Pain Symptom Inventory (NPSI) the participant rated their symptoms of neuropathic pain. Ten pain questions were answered on an 11-point scale, from 0 (symptom not present) to 10 (symptom at its worst imaginable intensity, e.g. worst burning imaginable). The overall NPSI score was calculated by the summation of all ten responses and ranges between 0 and 1. For pain descriptions burning, pressing, paroxysmal (pain like electric shocks or stabbing), evoked (due to touch) and paresthesia (sensation that is not unpleasant) or dysesthesia (unpleasant) sub-scores are reported. The overall values reported for all participants that completed the questionnaire are shown. A symptom was absent if the value is 0, the symptom was present in all participants and all participants rated it at its worst possible intensity if a value is 1. A negative change indicates that the intensity of the symptom has decreased since the start of treatment.
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 129 125
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Overall Score -0.353  (0.0208) -0.248  (0.0211)
Sub-Score Burning Pain -0.375  (0.0249) -0.278  (0.0252)
Sub-Score Pressing Pain -0.331  (0.0235) -0.226  (0.0238)
Sub-Score Paroxysmal Pain -0.385  (0.0246) -0.283  (0.0250)
Sub-score Evoked Pain -0.334  (0.0222) -0.225  (0.0225)
Sub-Score Pare/Dysesthesia -0.363  (0.0229) -0.252  (0.0231)
13.Secondary Outcome
Title Short Form Health Survey (SF-12)
Hide Description The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 125
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline Physical Functioning 33.256  (7.7695) 33.813  (6.8734)
End Continuation Period Physical functioning 41.701  (10.2556) 39.120  (9.4634)
Baseline Role-Physical 33.783  (6.5010) 33.695  (6.2586)
End Continuation Period Role-Physical 41.025  (8.7602) 38.757  (7.6342)
Baseline Bodily Pain 30.430  (7.9923) 31.117  (8.1434)
End Continuation Period Bodily Pain 42.003  (10.1964) 38.637  (10.3872)
Baseline General Health 36.110  (8.3196) 34.652  (7.0912)
End Continuation Period General Health 44.382  (10.3772) 39.941  (10.1717)
Baseline Vitality 46.518  (8.5121) 45.516  (8.0387)
End Continuation Period Vitality 51.202  (9.3262) 47.724  (10.0303)
Baseline Social Functioning 42.290  (10.5832) 41.734  (9.8674)
End Continuation Period Social Functioning 47.494  (10.4657) 44.475  (10.5281)
Baseline Role-Emotional 41.018  (13.0098) 37.046  (13.2164)
End Continuation Period Role-Emotional 44.727  (12.1390) 41.219  (12.7890)
Baseline Mental Health 44.967  (9.2036) 42.394  (9.1589)
End Continuation Period Mental health 49.828  (10.3896) 46.451  (10.3372)
Baseline Physical Component summary 30.319  (7.2739) 31.684  (6.8313)
End Continuation Period Physical component summary 40.493  (9.3352) 37.765  (8.8375)
Baseline Mental Component Summary 48.736  (11.5697) 45.216  (11.7462)
End Continuation Period Mental Component Summary 51.117  (11.0365) 47.595  (11.4544)
14.Secondary Outcome
Title Changes in the Short Form Health Survey (SF-12) at the End of Treatment
Hide Description

The Short Form Health Survey (SF-12) has several brief broad questions on 8 aspects of health (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health) that a participant was asked to score over the last week. The physical and mental summary scores were calculated from the individual responses. A higher score indicates a better participant perceived state of health. All domains were scored on a scale from 0 (lowest level of health) to 100 (highest level of health), with 100 representing the best possible health state.

The change in the SF-12 score shows an improvement in health from baseline if the values are positive. The higher the value the greater the improvement since starting the trial.

Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS), Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 129 125
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Physical Functioning 8.358  (0.8262) 5.073  (0.8361)
Role-Physical 7.260  (0.7115) 4.668  (0.7224)
Bodily Pain 10.990  (0.9462) 7.458  (0.9570)
General Health 8.447  (0.8702) 4.309  (0.8818)
Vitality 4.943  (0.8062) 1.468  (0.8179)
Social Functioning 5.246  (0.8870) 2.286  (0.8997)
Role-Emotional 4.764  (0.9472) 2.587  (0.9807)
Mental Health 5.158  (0.8386) 2.973  (0.8575)
Physical Component Summary 9.735  (0.7948) 6.202  (0.8058)
Mental Component Summary 3.077  (0.8457) 1.146  (0.8679)
15.Secondary Outcome
Title EuroQol-5 (EQ-5D) Health Status Index Outcome
Hide Description The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating "full health" and 0 representing "dead"). The higher the values (the closer the value is to 1) the better the health status in a treatment group.
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 125
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 0.3186  (0.29464) 0.3392  (0.31134)
End of Continuation Period 0.6686  (0.31683) 0.5745  (0.31378)
16.Secondary Outcome
Title Change in EuroQol-5 (EQ-5D) Health Status Index Outcome at the End of Treatment
Hide Description The participant scored the EuroQol-5 questionnaire. The EuroQol-5 questionnaire uses a health state classification with 5 dimensions. Each dimension was assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=extreme problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1 (with 1 indicating "full health" and 0 representing "dead"). The higher the values (the closer the value is to 1) the better the health status in a treatment group.
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 129 125
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
0.3395  (0.02785) 0.2398  (0.02811)
17.Secondary Outcome
Title Hospital Anxiety and Depression Scale: Anxiety
Hide Description

The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.

A decrease in values over the trial period indicate that there has been an improvement.

Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.3  (4.06) 8.2  (4.28)
End of Continuation Period 5.3  (4.40) 6.7  (4.58)
18.Secondary Outcome
Title Change in Hospital Anxiety and Depression Scale at the End of Treatment: Anxiety
Hide Description

The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe anxiety. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate anxiety. A score of 11 or above is considered to be a case of anxiety.

A negative sign indicates that there has been a decrease in anxiety since the start of treatment.

Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 124
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.1  (0.34) -1.1  (0.35)
19.Secondary Outcome
Title Hospital Anxiety and Depression Scale: Depression
Hide Description The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement.
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last observation carried forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 125
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 7.4  (4.08) 8.0  (4.08)
End of Continuation Period 5.1  (4.17) 6.5  (4.86)
20.Secondary Outcome
Title Change in Hospital Anxiety and Depression Scale at the End of Treatment: Depression
Hide Description The Hospital Anxiety and Depression Scale (HADS) is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises 14 items. Seven statements describe depression. Each answer is scored on a four-point scale (0-3). All seven answers are summed to a total score with a maximum score of 21 points. A score below 7 is not considered to indicate depression. A score of 11 or above is considered to be a case of depression. A decrease in values over time indicates that there has been an improvement. A negative change value indicates a decrease in the depression score since the start of treatment.
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last observation carried forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 124 114
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
-2.4  (0.34) -1.1  (0.36)
21.Secondary Outcome
Title Patient Global Impression of Change at the End of Treatment
Hide Description In the Patient Global Impression of Change (PGIC) the participant indicated the perceived change over the treatment period. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.”
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 129 125
Measure Type: Number
Unit of Measure: participants
Very Much Improved 27 18
Much Improved 43 19
Minimally Improved 32 46
No Change 21 29
Minimally Worse 3 6
Much Worse 2 4
Very Much Worse 1 3
22.Secondary Outcome
Title Clinician Global Impression of Change at the End of Treatment
Hide Description In the Clinician Global Impression of Change (CGIC) the clinician indicated the perceived change over the treatment period. The clinician was requested to choose one of seven categories for each participant. The Clinician rated the participants change as “very much improved,” “much improved,” “minimally improved,” “no change,” “minimally worse,” “much worse,” or “very much worse.”
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 128 123
Measure Type: Number
Unit of Measure: participants
Very Much Improved 32 18
Much Improved 44 25
Minimally Improved 22 37
No Change 21 26
Minimally Worse 6 7
Much Worse 3 9
Very Much Worse 0 1
23.Secondary Outcome
Title Sleep Evaluation at the End of Treatment: Change in the Overall Quality of Sleep
Hide Description

The sleep evaluation questionnaire was completed by the participant. The questionnaire measures 4 main concepts: 1 of the 4 main concepts being the overall quality of sleep.

The participant rated this categorically as being one of the following: excellent, good, fair or poor.

The improvement, no change or worsening is reported based on the replies scored by the participants given at their End of Continuation Visit.

Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 126
Measure Type: Number
Unit of Measure: participants
Improvement 62 43
No Change 46 56
Worsening 16 15
Missing 6 12
24.Secondary Outcome
Title Sleep Evaluation: Number of Awakenings
Hide Description

The participants were requested to answer the following question:

How many times did you wake up during the night? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization).

Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 125
Mean (Standard Deviation)
Unit of Measure: number of awakenings
Baseline 3.0  (2.80) 2.6  (1.67)
End of Continuation Period 2.0  (1.66) 2.2  (1.65)
25.Secondary Outcome
Title Sleep Evaluation at the End of Treatment: Change in the Number of Awakenings
Hide Description The participants were requested to answer the question: How many times did you wake up during the night? The values were calculated from the data that participants self-reported. The change from baseline in the number of times of waking up during the night in a treatment group is reported. A negative symbol indicates that there was a reduction in the number of awakenings.
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
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Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF). Number of participants with data available.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 124 114
Least Squares Mean (Standard Error)
Unit of Measure: number of awakenings
-0.8  (0.15) -0.5  (0.16)
26.Secondary Outcome
Title Sleep Evaluation: Number of Hours Slept
Hide Description

The participants were requested to answer the following question:

How long did you sleep last night [hours]? The values were calculated from the data that participants self-reported for the night prior to their Randomization Visit (Baseline) and for the night prior to the End of the Continuation Visit (12 weeks after randomization).

Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 125
Mean (Standard Deviation)
Unit of Measure: hours
Baseline 5.781  (1.5908) 5.675  (1.7118)
End of Continuation Period 6.207  (1.8007) 6.218  (1.8426)
27.Secondary Outcome
Title Sleep Evaluation at the End of Treatment: Change in the Number of Hours Slept
Hide Description The sleep evaluation questionnaire was completed by the participant. The answer was in response to the question: Sleep evaluation: How long did you sleep last night [hours]? The value reported is the change in the number of hours of sleep from baseline. The positive value indicates that there was an increase in the number of hours of sleep in a treatment group.
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation Carried Forward (LOCF).
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 126
Least Squares Mean (Standard Error)
Unit of Measure: hours
0.460  (0.1714) 0.412  (0.1763)
28.Secondary Outcome
Title Sleep Evaluation: Latency (Time Taken to Fall Asleep)
Hide Description The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the Randomization Visit (Baseline) and for the night prior to the Final Evaluation Visit (12 weeks after randomization). The higher the value the longer it took to fall asleep.
Time Frame Baseline (Randomization Visit); End of Continuation Period (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS).
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 126
Mean (Standard Deviation)
Unit of Measure: hours
Baseline 1.047  (1.1746) 1.203  (1.3029)
End of Continuation Period 0.803  (1.1154) 0.865  (1.0301)
29.Secondary Outcome
Title Sleep Evaluation at the End of Treatment: Change in Latency (Change in the Time Taken to Fall Asleep)
Hide Description The sleep evaluation questionnaire was completed by the participant. The participant was asked: How long after bedtime/lights out did you fall asleep last night [hours]? The values are for the night prior to the visits. The negative change from baseline indicates that the time to falling asleep decreased from baseline in a treatment group.
Time Frame Baseline (Randomization Visit); End of Continuation Visit (Week 12)
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS). Last Observation carried Forward (LOCF). Number of participants taken into account for the analyses.
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 124 114
Least Squares Mean (Standard Error)
Unit of Measure: hours
-0.300  (0.1000) -0.177  (0.1025)
30.Secondary Outcome
Title Comparison of the Number of Participants Affected by Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids
Hide Description

In this outcome measure the number of participants affected by early gastrointestinal-related treatment emergent adverse events (TEAEs). As the trial population was opioid-naïve this was considered of interest.

The composition score from participant who reported:

Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated.

Time Frame Baseline (Randomization Visit) to End of Titration Period (End of Week 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SAF).
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 128
Measure Type: Number
Unit of Measure: participants
42 59
31.Secondary Outcome
Title Composite Event Based Comparison of Gastrointestinal Treatment Emergent Adverse Events (TEAEs) Typical for Opioids
Hide Description

In this outcome measure the early gastrointestinal-related treatment emergent events (TEAEs) were evaluated. As the trial population was opioid-naïve this was considered of interest.

The composition score of reported events of Mild, moderate to severe nausea and/or Mild, moderate to severe vomiting and/or Mild, moderate to severe constipation was evaluated.

Time Frame Baseline (Randomization Visit); End of Week 3 (End of Titration Period)
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Set (SAF).
Arm/Group Title Tapentadol Prolonged Release Oxycodone/Naloxone Prolonged Release
Hide Arm/Group Description:
All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks.
Overall Number of Participants Analyzed 130 128
Measure Type: Number
Unit of Measure: number of events
56 81
Time Frame Adverse events occurring after first administration of study drug were listed (Treatment emergent adverse events - TEAEs) and within 3 days after the last intake were considered as TEAEs. Pre-treatment adverse events that worsened were considered TEAEs.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tapentadol Prolonged Release (PR) Oxycodone/Naloxone Prolonged Release (PR) Tapentadol (PR) After Oxycodone/Naloxone (PR) Treatment
Hide Arm/Group Description All participants started with 50 mg tapentadol prolonged release (twice daily). The dose of tapentadol prolonged release was adjusted in increments of 50 mg to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. All participants started with 10 mg/5 mg oxycodone/naloxone prolonged release (twice daily). The dose of oxycodone/naloxone prolonged release could be adjusted in increments of 10 mg/5 mg oxycodone/naloxone to a level that provided adequate analgesia. The next titration step was after a minimum of 3 days on a dose. Participants were permitted a maximum dose of 50 mg/20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants remained on the stable dose for 9 weeks. Participants in the oxycodone/naloxone PR treatment arm that did not reach the minimum target of titration or experiencing intolerable side effects at the end of the Titration Period could be switched to the Pick-up Arm. They could also enter the Pick-up Arm at any time during the Titration Period or Continuation Period, via an unscheduled visit, due to lack of tolerability or lack of efficacy under treatment with oxycodone/naloxone PR. Participants were directly switched from oxycodone/naloxone PR to tapentadol PR using an equianalgesic ratio of 1:5 (oxycodone : tapentadol), together with a down-titration step under tapentadol PR (except for participants on oxycodone/naloxone PR 10 mg/5 mg twice daily).
All-Cause Mortality
Tapentadol Prolonged Release (PR) Oxycodone/Naloxone Prolonged Release (PR) Tapentadol (PR) After Oxycodone/Naloxone (PR) Treatment
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tapentadol Prolonged Release (PR) Oxycodone/Naloxone Prolonged Release (PR) Tapentadol (PR) After Oxycodone/Naloxone (PR) Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/130 (2.31%)      2/128 (1.56%)      0/50 (0.00%)    
Eye disorders       
Retinal detachment * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Hepatobiliary disorders       
Bile duct stone * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Cholelithiasis * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Infections and infestations       
Tracheobronchitis * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tapentadol Prolonged Release (PR) Oxycodone/Naloxone Prolonged Release (PR) Tapentadol (PR) After Oxycodone/Naloxone (PR) Treatment
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   97/130 (74.62%)      105/128 (82.03%)      29/50 (58.00%)    
Cardiac disorders       
Palpitations * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Tachycardia * 1  1/130 (0.77%)  1 2/128 (1.56%)  2 0/50 (0.00%)  0
Tachycardia paroxysmal * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Ear and labyrinth disorders       
Tinnitus * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Vertigo * 1  0/130 (0.00%)  0 2/128 (1.56%)  2 0/50 (0.00%)  0
Eye disorders       
Ocular hyperaemia * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Vision blurred * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Visual impairment * 1  0/130 (0.00%)  0 2/128 (1.56%)  2 0/50 (0.00%)  0
Gastrointestinal disorders       
Abdominal distension * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Abdominal pain * 1  2/130 (1.54%)  2 1/128 (0.78%)  1 1/50 (2.00%)  1
Abdominal pain lower * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Abdominal pain upper * 1  5/130 (3.85%)  5 5/128 (3.91%)  6 1/50 (2.00%)  1
Bowel movement irregularity * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Colitis * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Constipation * 1  20/130 (15.38%)  20 33/128 (25.78%)  34 1/50 (2.00%)  1
Diarrhoea * 1  6/130 (4.62%)  6 0/128 (0.00%)  0 3/50 (6.00%)  3
Dry mouth * 1  9/130 (6.92%)  9 7/128 (5.47%)  8 0/50 (0.00%)  0
Dyspepsia * 1  2/130 (1.54%)  2 1/128 (0.78%)  1 0/50 (0.00%)  0
Eructation * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Flatulence * 1  1/130 (0.77%)  1 3/128 (2.34%)  3 0/50 (0.00%)  0
Gastritis * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Gastrooesophageal reflux disease * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Nausea * 1  29/130 (22.31%)  31 23/128 (17.97%)  23 5/50 (10.00%)  7
Paraesthesia oral * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Saliva altered * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Vomiting * 1  10/130 (7.69%)  11 21/128 (16.41%)  24 4/50 (8.00%)  4
General disorders       
Chills * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Drug withdrawal syndrome * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Fatigue * 1  39/130 (30.00%)  42 31/128 (24.22%)  32 2/50 (4.00%)  2
Influenza like illness * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Irritability * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Local swelling * 1  0/130 (0.00%)  0 2/128 (1.56%)  2 0/50 (0.00%)  0
Malaise * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Oedema peripheral * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Pain * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Pyrexia * 1  0/130 (0.00%)  0 0/128 (0.00%)  0 1/50 (2.00%)  1
Thirst * 1  1/130 (0.77%)  1 1/128 (0.78%)  1 0/50 (0.00%)  0
Hepatobiliary disorders       
Biliary colic * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Infections and infestations       
Bronchitis * 1  1/130 (0.77%)  3 1/128 (0.78%)  1 1/50 (2.00%)  1
Cystitis * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Furuncle * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Gastroenteritis * 1  3/130 (2.31%)  3 3/128 (2.34%)  3 0/50 (0.00%)  0
Gastrointestinal infection * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Influenza * 1  1/130 (0.77%)  2 0/128 (0.00%)  0 0/50 (0.00%)  0
Nasopharyngitis * 1  8/130 (6.15%)  8 5/128 (3.91%)  5 2/50 (4.00%)  2
Oral herpes * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Otitis media * 1  2/130 (1.54%)  2 0/128 (0.00%)  0 0/50 (0.00%)  0
Pulpitis dental * 1  2/130 (1.54%)  2 0/128 (0.00%)  0 0/50 (0.00%)  0
Respiratory tract infection * 1  1/130 (0.77%)  2 0/128 (0.00%)  0 0/50 (0.00%)  0
Tooth abscess * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Urinary tract Infection * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 1/50 (2.00%)  1
Viral upper respiratory tract infection * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Injury, poisoning and procedural complications       
Contusion * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Fall * 1  1/130 (0.77%)  2 0/128 (0.00%)  0 0/50 (0.00%)  0
Injury * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Ligament sprain * 1  0/130 (0.00%)  0 2/128 (1.56%)  2 0/50 (0.00%)  0
Thermal burn * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Traumatic haematoma * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Investigations       
Biopsy chest wall * 1  0/130 (0.00%)  0 0/128 (0.00%)  0 1/50 (2.00%)  1
Blood phosphorus decreased  1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Blood testosterone decreased  1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Creatinine renal clearance decreased  1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Hepatic enzyme increased  1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Weight decreased * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 1/50 (2.00%)  1
Metabolism and nutrition disorders       
Decreased appetite * 1  4/130 (3.08%)  5 5/128 (3.91%)  5 0/50 (0.00%)  0
Fluid retention * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Neck pain * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Exostosis * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Flank pain * 1  0/130 (0.00%)  0 0/128 (0.00%)  0 1/50 (2.00%)  1
Muscle spasms * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 1/50 (2.00%)  1
Myosclerosis * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Osteoporosis * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Pain in extremity * 1  1/130 (0.77%)  1 2/128 (1.56%)  2 0/50 (0.00%)  0
Plantar fasciitis * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Spinal pain * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Tendon pain * 1  2/130 (1.54%)  2 0/128 (0.00%)  0 0/50 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Melanocytic naevus * 1  0/130 (0.00%)  0 0/128 (0.00%)  0 1/50 (2.00%)  1
Nervous system disorders       
Balance disorder * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Carpal tunnel syndrome * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Cervicobrachial syndrome * 1  2/130 (1.54%)  2 1/128 (0.78%)  1 0/50 (0.00%)  0
Dizziness * 1  24/130 (18.46%)  26 22/128 (17.19%)  22 6/50 (12.00%)  6
Headache * 1  10/130 (7.69%)  10 5/128 (3.91%)  5 1/50 (2.00%)  1
Hypoaesthesia * 1  3/130 (2.31%)  3 5/128 (3.91%)  6 1/50 (2.00%)  1
Neuromuscular blockade * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 1/50 (2.00%)  1
Orthostatic intolerance * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Paraesthesia * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 1/50 (2.00%)  1
Sciatica * 1  1/130 (0.77%)  1 1/128 (0.78%)  1 0/50 (0.00%)  0
Somnolence * 1  3/130 (2.31%)  4 3/128 (2.34%)  3 0/50 (0.00%)  0
Speech disorder * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Syncope * 1  0/130 (0.00%)  0 0/128 (0.00%)  0 1/50 (2.00%)  1
Tremor * 1  1/130 (0.77%)  1 2/128 (1.56%)  2 1/50 (2.00%)  1
Vertigo cns origin * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 1/50 (2.00%)  1
Psychiatric disorders       
Apathy * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Claustrophobia * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Drug dependence * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Euphoric mood * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Insomnia * 1  4/130 (3.08%)  4 2/128 (1.56%)  2 0/50 (0.00%)  0
Nervousness * 1  1/130 (0.77%)  1 1/128 (0.78%)  1 0/50 (0.00%)  0
Restlessness * 1  2/130 (1.54%)  2 2/128 (1.56%)  2 0/50 (0.00%)  0
Sleep disorder * 1  1/130 (0.77%)  2 2/128 (1.56%)  2 0/50 (0.00%)  0
Tic * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Withdrawal syndrome * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Renal and urinary disorders       
Renal impairment * 1  0/130 (0.00%)  0 0/128 (0.00%)  0 1/50 (2.00%)  1
Renal pain * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Urinary retention * 1  1/130 (0.77%)  1 1/128 (0.78%)  1 0/50 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Chronic obstructive pulmonary disease * 1  0/130 (0.00%)  0 0/128 (0.00%)  0 1/50 (2.00%)  1
Dry throat * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Dyspnoea * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 1/50 (2.00%)  1
Epistaxis * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Respiratory distress * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Skin and subcutaneous tissue disorders       
Cold sweat * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Eczema * 1  1/130 (0.77%)  1 1/128 (0.78%)  1 0/50 (0.00%)  0
Erythema * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Haematidrosis * 1  1/130 (0.77%)  1 0/128 (0.00%)  0 0/50 (0.00%)  0
Hyperhidrosis * 1  8/130 (6.15%)  8 13/128 (10.16%)  13 4/50 (8.00%)  4
Pruritus * 1  8/130 (6.15%)  9 11/128 (8.59%)  12 0/50 (0.00%)  0
Rash * 1  1/130 (0.77%)  1 1/128 (0.78%)  1 0/50 (0.00%)  0
Rash pruritic * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Skin irritation * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Urticaria * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Surgical and medical procedures       
Vocal cord polypectomy * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Vascular disorders       
Hot flush * 1  7/130 (5.38%)  7 4/128 (3.13%)  4 0/50 (0.00%)  0
Hypertension * 1  3/130 (2.31%)  3 1/128 (0.78%)  1 2/50 (4.00%)  2
Hypertensive crisis * 1  0/130 (0.00%)  0 1/128 (0.78%)  1 0/50 (0.00%)  0
Hypotension * 1  1/130 (0.77%)  1 1/128 (0.78%)  1 0/50 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 16.1
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.
The sponsor reserves the right to review any publication pertaining to the trial before it is submitted for publication. Neither party has the right to prohibit publication unless publication can be shown to affect possible patent rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Grünenthal GmbH
Phone: +49 241 569 ext 3223
EMail: Clinical-Trials@grunenthal.com
Layout table for additonal information
Responsible Party: Grünenthal GmbH
ClinicalTrials.gov Identifier: NCT01838616     History of Changes
Other Study ID Numbers: KF5503/60
2012-002943-11 ( EudraCT Number )
First Submitted: April 19, 2013
First Posted: April 24, 2013
Results First Submitted: April 28, 2015
Results First Posted: June 8, 2015
Last Update Posted: February 24, 2016