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Trial record 1 of 1 for:    NCT00983385
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Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Chronic Low Back Pain Taking Either WHO Step I or Step II Analgesics or no Regular Analgesics

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ClinicalTrials.gov Identifier: NCT00983385
Recruitment Status : Completed
First Posted : September 24, 2009
Results First Posted : April 17, 2012
Last Update Posted : January 15, 2019
Sponsor:
Information provided by (Responsible Party):
Grünenthal GmbH

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Chronic Pain
Low Back Pain
Interventions Drug: Tapentadol PR
Other: Observation period
Enrollment 208
Recruitment Details The trial started on 30 September 2009 with enrollment of the first subject and the last follow-up examination took place on 06 July 2010.
Pre-assignment Details During the observation period (3 to 7 days in length) subjects recorded their analgesic medication intake and pain intensity. Prior to intake of tapentadol.
Arm/Group Title Tapentadol
Hide Arm/Group Description All participants started with 50 mg tapentadol hydrochloride prolonged release (PR) (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride immediate release (IR) 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Period Title: Observation Period
Started 208
Completed 176
Not Completed 32
Reason Not Completed
Not eligible to be dosed             20
Not Evaluable due to Non Compliance             12
Period Title: Titration and Optimal Dose Period
Started 176
Completed 140
Not Completed 36
Period Title: Maintenance Period
Started 140
Completed 117
Not Completed 23
Arm/Group Title Tapentadol
Hide Arm/Group Description All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Baseline Participants 176
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 176 participants
59.7  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 176 participants
Female
111
  63.1%
Male
65
  36.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 176 participants
France 14
Spain 52
Poland 11
Austria 26
Germany 46
United Kingdom 12
Switzerland 3
Italy 12
Prior analgesic medication  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 176 participants
Participants pretreated with opioids 88
Participants opioid naive (Step 1 analgesics) 87
Unknown 1
1.Primary Outcome
Title The Primary Endpoint is Defined as the Change of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6 From Week -1 (Baseline).
Hide Description For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine". The value indicates the change from the baseline participant assessment on the 0 to 10 scale. A negative value indicates a reduction in pain intensity.
Time Frame Baseline; End of Week 6 (6 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat. Last Observation Carried Forward (LOCF)
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 174
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-2.8  (2.12)
2.Secondary Outcome
Title Patient Global Impression of Change at End of Titration and Optimal Dose Period
Hide Description In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.
Time Frame Baseline; End of Week 6 (6 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 134
Measure Type: Number
Unit of Measure: participants
Very much improved 12
Much improved 55
Minimally improved 49
No change 10
Minimally worse 5
Much worse 2
Very much worse 1
3.Secondary Outcome
Title Patient Global Impression of Change at End of the Maintenance Period
Hide Description In the Patient Global Impression of Change (PGIC) the participant indicates the perceived change over the treatment period. The participant is requested to choose one of seven categories. Scores range from very much improved to very much worse.
Time Frame Baseline; End of Week 12 (12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: participants
Very much improved 19
Much improved 42
Minimally improved 23
No change 5
Minimally worse 0
Much worse 0
Very much worse 0
4.Secondary Outcome
Title Change in the Health Survey Scores Form (SF-36) at End of Titration and Optimal Dose Period
Hide Description The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (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. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.
Time Frame Baseline; End of Week 6 (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT)
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 133
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Physical Functioning 14.1  (17.23)
Bodily Pain 21.7  (21.39)
General Health 6.3  (16.18)
Vitality 8.0  (20.28)
Social Functioning 10.7  (25.84)
Role Emotional 14.8  (43.98)
Mental Health 7.5  (18.22)
Role Physical 25.0  (40.47)
5.Secondary Outcome
Title Change in the Health Survey Scores Form (SF-36) at End of Maintenance Period
Hide Description The Scores Form 36 (SF-36) includes several brief board questions on 8 aspects, (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. A higher score indicates an improvement in health. All domains are scored on a scale from 0 (negative health) to 100 (positive health), with 100 representing the best possible health state. A positive mean value indicates an improvement from baseline.
Time Frame Baseline; End of Week 12 (12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Physical Functioning 15.7  (21.95)
Bodily Pain 24.4  (21.96)
General Health 10.3  (14.95)
Vitality 9.5  (18.43)
Social Functioning 13.2  (27.85)
Role Emotional 18.6  (44.17)
Mental Health 12.0  (18.33)
Role Physical 29.2  (48.30)
6.Secondary Outcome
Title painDETECT Assessment at Baseline
Hide 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".
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title Baseline painDETECT Negative Group Baseline painDETECT Unclear Group Baseline painDETECT Positive Group
Hide Arm/Group Description:
Subgroup of participants with a score between 0 and 12.
Subgroup of participants with a score between 13 and 18.
Subgroup of participants with a score between 19 and 38.
Overall Number of Participants Analyzed 49 41 81
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.1  (3.26) 13.2  (3.36) 21.4  (5.05)
7.Secondary Outcome
Title painDETECT Assessment for Participants at End of Titration and Optimal Dose Period
Hide Description

The baseline painDETECT score was reassessed at the end of Week 6.

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".

Time Frame End of Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title Baseline painDETECT Negative Group Baseline painDETECT Unclear Group Baseline painDETECT Positive Group
Hide Arm/Group Description:
The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 6.
The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 6.
The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 6.
Overall Number of Participants Analyzed 34 32 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.5  (3.60) 9.8  (6.21) 14.4  (7.05)
8.Secondary Outcome
Title painDETECT Assessment for Participants at End of the Maintenance Period
Hide Description

The baseline painDETECT score was reassessed at the end of Week 12.

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".

Time Frame End of Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title Baseline painDETECT Negative Group Baseline painDETECT Unclear Group Baseline painDETECT Positive Group
Hide Arm/Group Description:
The subgroup of participants scoring 0-12 at the baseline painDETECT assessment were reassessed at the end of Week 12.
The subgroup of participants scoring 13-18 at the baseline painDETECT assessment were reassessed at the end of Week 12.
The subgroup of participants scoring 19-38 at the baseline painDETECT assessment were reassessed at the end of Week 12.
Overall Number of Participants Analyzed 23 21 45
Mean (Standard Deviation)
Unit of Measure: units on a scale
5.7  (4.22) 7.1  (6.13) 11.2  (7.52)
9.Secondary Outcome
Title Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at Baseline
Hide Description Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.
Time Frame Baseline Visit
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 124
Mean (Standard Deviation)
Unit of Measure: units on a scale
Sub-score burning pain 0.470  (0.310)
Sub-score pressing pain 0.549  (0.243)
Sub-score paroxysmal pain 0.575  (0.243)
Sub-score evoked pain 0.391  (0.263)
Sub-score paresthesia / dysthesia 0.539  (0.273)
Overall score 0.497  (0.180)
10.Secondary Outcome
Title Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score at End of Titration and Optimal Dose Period
Hide Description Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.
Time Frame End of Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 97
Mean (Standard Deviation)
Unit of Measure: units on a scale
Sub-score burning pain 0.260  (0.281)
Sub-score pressing pain 0.316  (0.257)
Sub-score paroxysmal pain 0.293  (0.258)
Sub-score evoked pain 0.230  (0.221)
Sub-score paresthesia / dysthesia 0.303  (0.2722)
Overall score 0.278  (0.204)
11.Secondary Outcome
Title Neuropathic Pain Symptom Inventory (NPSI) Subscores and Overall Score Assessment at End of the Maintenance Period
Hide Description Mean score NPSI (Neuropathic Pain Symptom Inventory). The participant rates their symptoms of neuropathic pain. Ten pain questions are answered on an 11-point scale 0 (no pain) to 10 (most intense pain imaginable). Two items related to temporal pain assessed on 5-point scales.
Time Frame End of Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 66
Mean (Standard Deviation)
Unit of Measure: units on a scale
Sub-score burning pain 0.180  (0.237)
Sub-score pressing pain 0.235  (0.218)
Sub-score paroxysmal pain 0.211  (0.225)
Sub-score evoked pain 0.175  (0.188)
Sub-score paresthesia / dysthesia 0.231  (0.270)
Overall score 0.206  (0.198)
12.Secondary Outcome
Title Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of Titration and Optimal Dose Period
Hide Description Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.
Time Frame Baseline; End of Week 6 (6 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT), Last Observation Carried Forward (LOCF).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 95
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-0.224  (0.213)
13.Secondary Outcome
Title Change in Neuropathic Pain Symptom Inventory (NPSI) Final Score Assessment at End of the Maintenance Period
Hide Description Change in mean score NPSI, questionnaire evaluates symptoms of neuropathic pain. Ten pain descriptors questions are answered on an 11-point scale 0 (no pain)-10 (most intense pain imaginable). The NPSI derives a total intensity score calculated from the subscores. A negative value indicates improvement in neuropathic symptoms.
Time Frame Baseline; End of Week 12 (12 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT), Last Observation Carried Forward (LOCF).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 65
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.296  (0.228)
14.Secondary Outcome
Title EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Titration and Optimal Dose Period.
Hide Description The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is 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 1.00 indicating "full health" and 0 representing dead. The positive values indicate that during the study the health status improved.
Time Frame Baseline; End of Week 6 (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). painDETECT negative subpopulation - 35 participants. Unclear and positive painDETECT subpopulation - 98 participants.
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 133
Mean (Standard Deviation)
Unit of Measure: Units on a scale
All participants 0.244  (0.315)
Participants painDETECT negative 0.229  (0.321)
Participant painDETECT unclear or positive 0.249  (0.315)
15.Secondary Outcome
Title Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)at End of Titration and Optimal Dose Period.
Hide Description EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.
Time Frame Baseline; End of Week 6 (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). painDETECT negative subpopulation - 34 participants. Unclear and positive painDETECT subpopulation - 97 participants.
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 131
Mean (Standard Deviation)
Unit of Measure: Units on a scale
All participants 12.2  (25.08)
Participants painDETECT negative 7.6  (19.74)
Participant painDETECT unclear or positive 13.8  (26.61)
16.Secondary Outcome
Title EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time at End of Maintenance Period
Hide Description The participant scored the EuroQol-5. This is a five dimensional health state classification. Each dimension is 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 1.00 indicating "full health" and 0 representing dead. The positive values indicate that during the study the health status improved.
Time Frame Baseline; End of Week 12 (12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). Unclear and positive painDETECT subpopulation - 66 participants. painDETECT negative subpopulation - 23 participants.
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
All participants 0.282  (0.297)
Participants painDETECT negative 0.182  (0.252)
Participants painDETECT unclear or positive 0.316  (0.306)
17.Secondary Outcome
Title Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS) at End of Maintenance Period
Hide Description EuroQoL-5D Health State Visual Analog Scale (VAS) is a participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 (worst imaginable health state) to 100 (best imaginable health state); higher scores indicate a better health state. The values indicated represent the change from the baseline, a positive value indicates an improvement.
Time Frame Baseline; End of Week 12 (12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). painDETECT negative subpopulation - 23 participants. Unclear and positive painDETECT subpopulation - 66 participants.
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: Units on a scale
All participants 20.0  (27.27)
Participants painDETECT negative 14.7  (26.68)
Participant painDETECT unclear or positive 21.8  (27.44)
18.Secondary Outcome
Title Clinical Global Impression of Change (All Participants) at End of Titration and Optimal Dose Period
Hide Description In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.
Time Frame Baseline; End of Week 6 (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 134
Measure Type: Number
Unit of Measure: participants
Very much improved 17
Much improved 53
Minimally improved 49
No change 11
Minimally worse 2
Much worse 1
Very much worse 1
19.Secondary Outcome
Title Clinical Global Impression of Change (All Participants) at End of Maintenance Period
Hide Description In the Clinical Global Impression of Change (CGIC) the clinician indicates the perceived change over the treatment period. The clinician is requested to choose one of seven categories. Scores range from very much improved to very much worse.
Time Frame Baseline; End of Week 12 (12 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: participants
Very much improved 17
Much improved 45
Minimally improved 22
No change 5
20.Secondary Outcome
Title Hospital Anxiety Depression Scale (HADS): Anxiety Score at Baseline
Hide Description

Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.

HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 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 negative value indicates that there has been an improvement.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 173
Mean (Standard Deviation)
Unit of Measure: units on a scale
All participants 7.8  (4.32)
Negative painDETECT participants 6.2  (4.10)
Unclear and positive painDETECT participants 8.4  (4.26)
21.Secondary Outcome
Title Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Titration and Optimal Dose Period
Hide Description

Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.

HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 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 negative value indicates that there has been an improvement.

Time Frame Baseline; End of Week 6 (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Negative painDETECT subpopulation - 34 participants Unclear and positive painDETECT subpopulation - 94 participants Intention to Treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
All participants -1.2  (3.36)
Negative painDETECT participants -0.3  (2.93)
Unclear and positive painDETECT participants -1.5  (3.47)
22.Secondary Outcome
Title Hospital Anxiety Depression Scale: Change in Anxiety Score at End of Maintenance Period
Hide Description

Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.

HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 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 negative value indicates that there has been an improvement.

Time Frame Baseline; End of Week 12 (12 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants Intention to Treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
All participants -2.1  (3.67)
Negative painDETECT participants -0.8  (2.82)
Unclear and positive painDETECT participants -2.5  (3.85)
23.Secondary Outcome
Title Hospital Anxiety Depression Scale: Depression Score at Baseline
Hide Description

Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.

HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 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 negative value indicates that there has been an improvement.

Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Negative painDETECT subpopulation - 49 participants Unclear and positive painDETECT subpopulation - 124 participants Intention to Treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 173
Mean (Standard Deviation)
Unit of Measure: units on a scale
All participants 7.9  (4.27)
Negative painDETECT participants 6.5  (3.96)
Unclear and positive painDETECT participants 8.5  (4.27)
24.Secondary Outcome
Title Hospital Anxiety Depression Scale: Change in Depression Score at End of Titration and Optimal Dose Period.
Hide Description

Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.

HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 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 negative value indicates that there has been an improvement.

Time Frame Baseline; End of Week 6 (6 weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Negative painDETECT subpopulation - 34 participants Unclear or positive painDETECT subpopulation - 94 participants Intention to Treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 128
Mean (Standard Deviation)
Unit of Measure: units on a scale
All participants -1.2  (3.40)
Negative painDETECT participants -1.0  (3.15)
Unclear and positive painDETECT participants -1.3  (3.50)
25.Secondary Outcome
Title Hospital Anxiety Depression Scale: Change in Depression Score at End of Maintenance Period
Hide Description

Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.

HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 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 negative value indicates that there has been an improvement.

Time Frame Baseline; End of Week 12 (12 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description

Negative painDETECT subpopulation - 23 participants Unclear and positive painDETECT subpopulation - 66 participants.

Intention to Treat (ITT).

Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: units on a scale
All participants -1.6  (3.24)
Negative painDETECT participants -0.5  (2.86)
Unclear and positive painDETECT participants -2.0  (3.30)
26.Secondary Outcome
Title Final Stable Tapentadol PR Dose in Opioid Naive Participants at End of Titration and Optimal Dose Period.
Hide Description Tapentadol hydrochloride PR dose after 5 weeks of titration which was to be kept stable during the remained of the trial.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Negative painDETECT subpopulation - 22 participants Unclear painDETECT subpopulation - 15 participants Positive painDETECT subpopulation - 22 participants Intention to treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: milligrams (mg)
Negative painDETECT participants 336.4  (132.90)
Unclear painDETECT participants 293.3  (103.28)
Positive painDETECT participants 268.2  (132.33)
27.Secondary Outcome
Title Participant's Satisfaction With Previous Analgesic Treatment at Baseline
Hide Description Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous analgesic medication was rated as excellent, very good, good, fair and poor.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 175
Measure Type: Number
Unit of Measure: participants
Good 2
Fair 98
Poor 75
28.Secondary Outcome
Title Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at the End of Titration and Optimal Dose Period.
Hide Description Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.
Time Frame End of Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 134
Measure Type: Number
Unit of Measure: participants
Excellent 12
Very Good 29
Good 64
Fair 22
Poor 7
29.Secondary Outcome
Title Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, in the Maintenance Period.
Hide Description Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.
Time Frame End of Week 8
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 122
Measure Type: Number
Unit of Measure: participants
Excellent 14
Very Good 30
Good 58
Fair 17
Poor 3
30.Secondary Outcome
Title Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol, at End of the Maintenance Period.
Hide Description Participants were requested to rate their tapentadol (new) analgesic medication on a 5-point scale. The medication was rated as excellent, very good, good, fair and poor.
Time Frame End of Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT).
Arm/Group Title Tapentadol
Hide Arm/Group Description:
All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.
Overall Number of Participants Analyzed 89
Measure Type: Number
Unit of Measure: participants
Excellent 10
Very Good 38
Good 28
Fair 11
Poor 2
31.Secondary Outcome
Title Baseline NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment, at Baseline.
Hide Description For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). Negative painDETECT subpopulation - 31 participants. Unclear and positive painDETECT subpopulation - 56 participants
Arm/Group Title Tapentadol
Hide Arm/Group Description:

Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants that entered the titration and optimal dose period.

All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.

Overall Number of Participants Analyzed 87
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Negative painDETECT participants 7.3  (0.78)
Unclear and positive painDETECT participants 7.4  (1.00)
32.Secondary Outcome
Title NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.
Hide Description For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time Frame End of Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). Negative painDETECT subpopulation - 22 participants. Unclear and positive painDETECT subpopulation - 37 participants
Arm/Group Title Tapentadol
Hide Arm/Group Description:

NRS-3 pain intensity values at End of Week 6 in PainDetect specific subgroup of participants that entered the titration and optimal dose period.

All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.

Overall Number of Participants Analyzed 59
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Negative painDETECT participants 4.0  (1.77)
Unclear and positive painDETECT participants 4.1  (1.86)
33.Secondary Outcome
Title NRS-3 Pain Intensity in Participants With No Prior Opioid Treatment at the End of the Maintenance Period.
Hide Description For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time Frame End of Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). Negative painDETECT subpopulation - 15 participants. Unclear and positive painDETECT subpopulation - 24 participants
Arm/Group Title Tapentadol
Hide Arm/Group Description:

NRS-3 pain intensity values at End of Week 12 in PainDetect specific subgroup of participants that entered the maintenance period.

All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.

Overall Number of Participants Analyzed 39
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Negative painDETECT participants 3.1  (1.81)
Unclear and positive painDETECT participants 3.4  (2.32)
34.Secondary Outcome
Title Baseline NRS-3 Pain Intensity in Participants With Prior Opioid Treatment, at Baseline.
Hide Description For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). Negative painDETECT subpopulation - 18 participants. Unclear and positive painDETECT subpopulation - 70 participants
Arm/Group Title Tapentadol
Hide Arm/Group Description:
Baseline(week -1) NRS-3 pain intensity values in PainDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period.
Overall Number of Participants Analyzed 88
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Negative painDETECT participants 6.7  (0.96)
Unclear and positive painDETECT participants 7.6  (1.07)
35.Secondary Outcome
Title NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Titration and Optimal Dose Period.
Hide Description For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time Frame End of Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). Negative painDETECT subpopulation - 13 participants. Unclear and positive painDETECT subpopulation - 62 participants
Arm/Group Title Tapentadol
Hide Arm/Group Description:

NRS-3 pain intensity values at end of Week 6 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the titration and optimal dose period.

All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.

Overall Number of Participants Analyzed 75
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Negative painDETECT participants 4.2  (1.96)
Unclear and positive painDETECT participants 4.4  (2.26)
36.Secondary Outcome
Title NRS-3 Pain Intensity Assessment in Participants With Prior Opioid Treatment at the End of the Maintenance Period.
Hide Description For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days on an 11-point Numerical Rating Scale(NRS) where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine".
Time Frame End of Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat (ITT). Negative painDETECT subpopulation - 8 participants. Unclear and positive painDETECT subpopulation - 42 participants
Arm/Group Title Tapentadol
Hide Arm/Group Description:

NRS-3 pain intensity values at End of Week 12 in painDetect specific subgroup of participants, with prior opioid treatment, that entered the maintenance period.

All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached. Tapentadol PR was administered for 12 weeks in total.

Overall Number of Participants Analyzed 50
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Negative painDETECT participants 3.4  (1.92)
Unclear and positive painDETECT participants 3.2  (1.94)
Time Frame 12 weeks
Adverse Event Reporting Description The total daily dose of tapentadol hydrochloride PR ranged from 50 mg to 500 mg.
 
Arm/Group Title Tapentadol
Hide Arm/Group Description All participants started with 50 mg tapentadol hydrochloride PR (twice daily). The dose of tapentadol hydrochloride PR was adjusted to a level that provided adequate analgesia (upwards or downwards on a weekly basis as needed). After 5 weeks the doses of tapentadol hydrochloride was kept stable. Participants were permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). Tapentadol hydrochloride IR 50 mg (no more than twice daily; at least 4 hours apart) was considered as medication for acute pain episodes, however participants were not permitted to dose tapentadol hydrochloride IR once 500 mg tapentadol hydrochloride PR dose was reached.
All-Cause Mortality
Tapentadol
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Tapentadol
Affected / at Risk (%)
Total   7/176 (3.98%) 
Hepatobiliary disorders   
Cholecystitis acute * 1  1/176 (0.57%) 
Infections and infestations   
Sepsis * 1  1/176 (0.57%) 
Investigations   
Blood insulin abnormal * 1  1/176 (0.57%) 
Metabolism and nutrition disorders   
Type 2 diabetes mellitus * 1  1/176 (0.57%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Renal cell carcinoma * 1  1/176 (0.57%) 
Psychiatric disorders   
Confusional state * 1  1/176 (0.57%) 
Renal and urinary disorders   
Renal colic * 1  1/176 (0.57%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tapentadol
Affected / at Risk (%)
Total   148/176 (84.09%) 
Gastrointestinal disorders   
Abdominal upper pain * 1  9/176 (5.11%) 
Constipation * 1  20/176 (11.36%) 
Diarrhoea * 1  20/176 (11.36%) 
Dry mouth * 1  27/176 (15.34%) 
Nausea * 1  37/176 (21.02%) 
Vomiting * 1  11/176 (6.25%) 
General disorders   
Fatigue * 1  22/176 (12.50%) 
Infections and infestations   
Nasopharyngitis * 1  20/176 (11.36%) 
Nervous system disorders   
Dizziness * 1  31/176 (17.61%) 
Headache * 1  29/176 (16.48%) 
Somnolence * 1  18/176 (10.23%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis * 1  9/176 (5.11%) 
Pruritus * 1  9/176 (5.11%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 13.0
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.
Grünenthal 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: Director of Clinical Trials
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: NCT00983385    
Other Study ID Numbers: 787579
2009-010427-12 ( EudraCT Number )
KF5503/44 ( Other Identifier: Sponsor )
First Submitted: September 23, 2009
First Posted: September 24, 2009
Results First Submitted: August 2, 2011
Results First Posted: April 17, 2012
Last Update Posted: January 15, 2019