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Trial record 1 of 1 for:    NCT00983073
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Evaluation of Effectiveness and Tolerability of Tapentadol Hydrochloride in Subjects With Severe Pain Due to Osteoarthritis Taking Either WHO Step I or Step II Analgesics or no Regular Analgesic

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ClinicalTrials.gov Identifier: NCT00983073
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : March 29, 2012
Last Update Posted : October 21, 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
Osteoarthritis
Intervention Drug: Tapentadol
Enrollment 224
Recruitment Details The enrollment of the first participant was on the 21 September 2009 and was completed on 02 September 2010 (when the last subject completed the last follow-up examination).
Pre-assignment Details The Trial had a duration of 13 weeks. The one week Observation Period did not involve dosing with Tapentadol. For Tapentadol analyses purposes the first 6 weeks of dosing with Tapentadol are reported as one period, Titration and Optimal Dose Period. The last 6 weeks on Tapentadol are reported as the Maintenance Period.
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Period Title: Observation Period
Started 224
Completed 200 [1]
Not Completed 24
[1]
24 participants not eligible to be dosed.
Period Title: Titration and Optimal Dose Period
Started 200
Completed 160
Not Completed 40
Reason Not Completed
Adverse Event             19
Withdrawal by Subject             11
Lack of Efficacy             5
Non-Compliance             1
Other reason             4
Period Title: Maintenance Period
Started 160
Completed 144
Not Completed 16
Reason Not Completed
Adverse Event             5
Withdrawal by Subject             2
Lack of Efficacy             2
Other Reason             7
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Baseline Participants 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
40 years and older Number Analyzed 200 participants
67.4  (10.8)
[1]
Measure Description: Age of all participants receiving at least one dose of study medication.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 200 participants
Female
135
  67.5%
Male
65
  32.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 200 participants
France 24
Poland 6
Spain 57
Germany 91
United Kingdom 22
Baseline Average Pain Intensity   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 200 participants
7.5  (1.08)
[1]
Measure Description:

For this pain assessment, the participant was to indicate the level of average pain experienced over the previous 3 days, prior to starting Tapentadol, 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".

This value was obtained from 195 participants.

1.Primary Outcome
Title The Primary Endpoint is Defined as the Change From Week -1 of the Average Pain Intensity Score on an 11-point NRS-3 at Week 6.
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 value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity.
Time Frame Baseline to end of week 6
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who had at least one dose of study medication and one post-baseline pain intensity assessment. Last Observation Carried Forward (LOCF).
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 193
Mean (Standard Deviation)
Unit of Measure: Units on a scale
-3.4  (2.10)
2.Secondary Outcome
Title Average Pain Intensity Before the Start of Tapentadol Treatment
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
[Not Specified]
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: units on a scale
7.5  (1.08)
3.Secondary Outcome
Title Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment
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 value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity.
Time Frame Baseline; End of Week 6 (6 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with data available.
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 160
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.8  (1.94)
4.Secondary Outcome
Title Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment
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 value on the 0 to 10 scale. A Negative value indicates a reduction in pain intensity from the baseline average pain intensity.
Time Frame Baseline; End of Week 12 (12 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with data available.
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.4  (1.91)
5.Secondary Outcome
Title EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time
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
Number of participants with data available.
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 159
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.23  (0.30)
6.Secondary Outcome
Title EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time
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
Number of participants with data available
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: Units on a scale
0.27  (0.34)
7.Secondary Outcome
Title Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)
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
Number of participants with data available.
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 158
Mean (Standard Deviation)
Unit of Measure: Units on a scale
15.8  (22.8)
8.Secondary Outcome
Title Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)
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
Number of participants with data available
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: Units on a scale
19.5  (26.6)
9.Secondary Outcome
Title Patient Global Impression of Change
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
Number of participants with data available
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 159
Measure Type: Number
Unit of Measure: Participants
Very Much Improved 14
Much Improved 75
Minimally Improved 58
No Change 8
Minimally Worse 2
Much Worse 2
Very Much Worse 0
10.Secondary Outcome
Title Patient Global Impression of Change
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
Number of participants with data available
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 125
Measure Type: Number
Unit of Measure: Participants
Very Much Improved 23
Much Improved 64
Minimally Improved 33
No Change 5
Minimally Worse 0
Much Worse 0
Very Much Worse 0
11.Secondary Outcome
Title Clinical Global Impression of Change
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
Number of participants with data available
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: Participants
Very Much Improved 14
Much Improved 88
Minimally Improved 47
No Change 7
Minimally Worse 2
Much Worse 1
Very Much Worse 1
12.Secondary Outcome
Title Clinical Global Impression of Change
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
Number of participants with data available
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 125
Measure Type: Number
Unit of Measure: Participants
Very Much Improved 28
Much Improved 68
Minimally Improved 27
No Change 2
Minimally Worse 0
Much Worse 0
Very Much Worse 0
13.Secondary Outcome
Title Participant's Satisfaction With Previous Analgesic Treatment
Hide Description Participants were requested to rate their previous analgesic medication on a 5-point scale. Previous medication was rated as excellent, very good, good, fair and poor.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with data available.
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 194
Measure Type: Number
Unit of Measure: participants
Excellent 0
Very Good 0
Good 4
Fair 132
Poor 62
14.Secondary Outcome
Title Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
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 Baseline; End of Week 6 (6 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with data available
Arm/Group Title Tapentadol PR
Hide Arm/Group Description:
All participants started with either 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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 160
Measure Type: Number
Unit of Measure: participants
Excellent 16
Very Good 39
Good 88
Fair 17
Poor 0
15.Secondary Outcome
Title Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
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 Baseline; End of Week 12 (12 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with data available
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 125
Measure Type: Number
Unit of Measure: participants
Excellent 16
Very Good 45
Good 54
Fair 9
Poor 1
16.Secondary Outcome
Title Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee
Hide Description Western Ontario McMaster Questionnaire (WOMAC) Global Score: WOMAC is measured with a Likert ordinal scale (the participant gives one of 5 possible answers) A higher score indicate that a symptom is bothersome or disabling. The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. A lower score indicates a lower level of symptoms and or disability.
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with data available
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 195
Mean (Standard Deviation)
Unit of Measure: units on a scale
53.6  (14.58)
17.Secondary Outcome
Title Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 6
Hide Description The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.
Time Frame Baseline; End of Week 6 (6 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with data available
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 159
Mean (Standard Deviation)
Unit of Measure: units on a scale
-21.0  (18.82)
18.Secondary Outcome
Title Change From Baseline in the Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee Over the Last Week at Week 12
Hide Description The WOMAC is a self-administered questionnaire and has 24 questions: Pain, Stiffness and Physical Function. The possible scores range from 0-20 for pain, 0-8 for stiffness, 0-68 for physical function and these are then summed 0-96 for the global score. The negative value indicates that there has been an improvement since baseline, the higher the value the greater the change since baseline.
Time Frame Baseline; End of Week 12 (12 Weeks)
Hide Outcome Measure Data
Hide Analysis Population Description
Number of participants with data available
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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.
Overall Number of Participants Analyzed 125
Mean (Standard Deviation)
Unit of Measure: units on a scale
-27.6  (19.52)
Time Frame From first tapentadol dose to the end of week 12 of tapentadol treatment.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tapentadol PR
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 dose of tapentadol hydrochloride PR 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 PR
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Tapentadol PR
Affected / at Risk (%)
Total   8/200 (4.00%) 
Cardiac disorders   
Angina unstable * 1  1/200 (0.50%) 
Myocardial infarction * 1  1/200 (0.50%) 
Infections and infestations   
Cellulitis * 1  1/200 (0.50%) 
Respiratory Tract Infection * 1  1/200 (0.50%) 
Urinary tract infection * 1  1/200 (0.50%) 
Injury, poisoning and procedural complications   
Radius fracture * 1  1/200 (0.50%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  1/200 (0.50%) 
Nervous system disorders   
Facial palsy * 1  1/200 (0.50%) 
Psychiatric disorders   
Panic attack * 1  1/200 (0.50%) 
Vascular disorders   
Deep vein thrombosis * 1  1/200 (0.50%) 
*
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 PR
Affected / at Risk (%)
Total   142/200 (71.00%) 
Gastrointestinal disorders   
Constipation * 1  21/200 (10.50%) 
Diarrhoea * 1  11/200 (5.50%) 
Dry Mouth * 1  20/200 (10.00%) 
Nausea * 1  26/200 (13.00%) 
Vomiting * 1  10/200 (5.00%) 
General disorders   
Fatigue * 1  21/200 (10.50%) 
Infections and infestations   
Nasopharyngitis * 1  16/200 (8.00%) 
Nervous system disorders   
Dizziness * 1  24/200 (12.00%) 
Headache * 1  13/200 (6.50%) 
Somnolence * 1  14/200 (7.00%) 
*
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: Clinical Trial Helpdesk
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: NCT00983073    
Other Study ID Numbers: 441172
2009-010423-58 ( EudraCT Number )
First Submitted: September 21, 2009
First Posted: September 23, 2009
Results First Submitted: December 6, 2011
Results First Posted: March 29, 2012
Last Update Posted: October 21, 2019