Trial Outcomes & Findings for 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 (NCT NCT00983073)
NCT ID: NCT00983073
Last Updated: 2019-10-21
Results Overview
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.
COMPLETED
PHASE3
224 participants
Baseline to end of week 6
2019-10-21
Participant Flow
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).
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.
Participant milestones
| Measure |
Tapentadol PR
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.
|
|---|---|
|
Observation Period
STARTED
|
224
|
|
Observation Period
COMPLETED
|
200
|
|
Observation Period
NOT COMPLETED
|
24
|
|
Titration and Optimal Dose Period
STARTED
|
200
|
|
Titration and Optimal Dose Period
COMPLETED
|
160
|
|
Titration and Optimal Dose Period
NOT COMPLETED
|
40
|
|
Maintenance Period
STARTED
|
160
|
|
Maintenance Period
COMPLETED
|
144
|
|
Maintenance Period
NOT COMPLETED
|
16
|
Reasons for withdrawal
| Measure |
Tapentadol PR
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.
|
|---|---|
|
Titration and Optimal Dose Period
Adverse Event
|
19
|
|
Titration and Optimal Dose Period
Withdrawal by Subject
|
11
|
|
Titration and Optimal Dose Period
Lack of Efficacy
|
5
|
|
Titration and Optimal Dose Period
Non-Compliance
|
1
|
|
Titration and Optimal Dose Period
Other reason
|
4
|
|
Maintenance Period
Adverse Event
|
5
|
|
Maintenance Period
Withdrawal by Subject
|
2
|
|
Maintenance Period
Lack of Efficacy
|
2
|
|
Maintenance Period
Other Reason
|
7
|
Baseline Characteristics
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
Baseline characteristics by cohort
| Measure |
Tapentadol PR
n=200 Participants
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.
|
|---|---|
|
Age, Customized
40 years and older
|
67.4 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
65 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
57 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
91 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
22 participants
n=5 Participants
|
|
Baseline Average Pain Intensity
|
7.5 Units on a scale
STANDARD_DEVIATION 1.08 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to end of week 6Population: All participants who had at least one dose of study medication and one post-baseline pain intensity assessment. Last Observation Carried Forward (LOCF).
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.
Outcome measures
| Measure |
Tapentadol PR
n=193 Participants
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.
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|---|---|
|
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.
|
-3.4 Units on a scale
Standard Deviation 2.10
|
SECONDARY outcome
Timeframe: BaselineFor 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".
Outcome measures
| Measure |
Tapentadol PR
n=195 Participants
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.
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|---|---|
|
Average Pain Intensity Before the Start of Tapentadol Treatment
|
7.5 units on a scale
Standard Deviation 1.08
|
SECONDARY outcome
Timeframe: Baseline; End of Week 6 (6 Weeks)Population: Number of participants with data available.
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.
Outcome measures
| Measure |
Tapentadol PR
n=160 Participants
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.
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|---|---|
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Change in Average Pain Intensity After 6 Weeks of Tapentadol PR Treatment
|
-3.8 units on a scale
Standard Deviation 1.94
|
SECONDARY outcome
Timeframe: Baseline; End of Week 12 (12 Weeks)Population: Number of participants with data available.
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.
Outcome measures
| Measure |
Tapentadol PR
n=125 Participants
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.
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|---|---|
|
Change in Average Pain Intensity After 12 Weeks of Tapentadol PR Treatment
|
-4.4 units on a scale
Standard Deviation 1.91
|
SECONDARY outcome
Timeframe: Baseline; End of Week 6 (6 Weeks)Population: Number of participants with data available.
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.
Outcome measures
| Measure |
Tapentadol PR
n=159 Participants
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.
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|---|---|
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EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time
|
0.23 Units on a scale
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Baseline; End of Week 12 (12 Weeks)Population: Number of participants with data available
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.
Outcome measures
| Measure |
Tapentadol PR
n=125 Participants
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.
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|---|---|
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EuroQol-5 (EQ-5D) Health Status Index Outcome Over Time
|
0.27 Units on a scale
Standard Deviation 0.34
|
SECONDARY outcome
Timeframe: Baseline; End of Week 6 (6 Weeks)Population: Number of participants with data available.
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.
Outcome measures
| Measure |
Tapentadol PR
n=158 Participants
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.
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|---|---|
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Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)
|
15.8 Units on a scale
Standard Deviation 22.8
|
SECONDARY outcome
Timeframe: Baseline, End of Week 12 (12 Weeks)Population: Number of participants with data available
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.
Outcome measures
| Measure |
Tapentadol PR
n=125 Participants
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.
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|---|---|
|
Change in Health Related Quality of Life: EuroQol-5D Health State Visual Analog Scale (VAS)
|
19.5 Units on a scale
Standard Deviation 26.6
|
SECONDARY outcome
Timeframe: Baseline; End of Week 6 (6 Weeks)Population: Number of participants with data available
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.
Outcome measures
| Measure |
Tapentadol PR
n=159 Participants
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.
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|---|---|
|
Patient Global Impression of Change
Very Much Improved
|
14 Participants
|
|
Patient Global Impression of Change
Much Improved
|
75 Participants
|
|
Patient Global Impression of Change
Minimally Improved
|
58 Participants
|
|
Patient Global Impression of Change
No Change
|
8 Participants
|
|
Patient Global Impression of Change
Minimally Worse
|
2 Participants
|
|
Patient Global Impression of Change
Much Worse
|
2 Participants
|
|
Patient Global Impression of Change
Very Much Worse
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline; End of Week 12 (12 Weeks)Population: Number of participants with data available
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.
Outcome measures
| Measure |
Tapentadol PR
n=125 Participants
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.
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|---|---|
|
Patient Global Impression of Change
Very Much Improved
|
23 Participants
|
|
Patient Global Impression of Change
Much Improved
|
64 Participants
|
|
Patient Global Impression of Change
Minimally Improved
|
33 Participants
|
|
Patient Global Impression of Change
No Change
|
5 Participants
|
|
Patient Global Impression of Change
Minimally Worse
|
0 Participants
|
|
Patient Global Impression of Change
Much Worse
|
0 Participants
|
|
Patient Global Impression of Change
Very Much Worse
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline; End of Week 6 (6 Weeks)Population: Number of participants with data available
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.
Outcome measures
| Measure |
Tapentadol PR
n=160 Participants
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.
|
|---|---|
|
Clinical Global Impression of Change
Very Much Improved
|
14 Participants
|
|
Clinical Global Impression of Change
Much Improved
|
88 Participants
|
|
Clinical Global Impression of Change
Minimally Improved
|
47 Participants
|
|
Clinical Global Impression of Change
No Change
|
7 Participants
|
|
Clinical Global Impression of Change
Minimally Worse
|
2 Participants
|
|
Clinical Global Impression of Change
Much Worse
|
1 Participants
|
|
Clinical Global Impression of Change
Very Much Worse
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline; End of Week 12 (12 Weeks)Population: Number of participants with data available
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.
Outcome measures
| Measure |
Tapentadol PR
n=125 Participants
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.
|
|---|---|
|
Clinical Global Impression of Change
Very Much Improved
|
28 Participants
|
|
Clinical Global Impression of Change
Much Improved
|
68 Participants
|
|
Clinical Global Impression of Change
Minimally Improved
|
27 Participants
|
|
Clinical Global Impression of Change
No Change
|
2 Participants
|
|
Clinical Global Impression of Change
Minimally Worse
|
0 Participants
|
|
Clinical Global Impression of Change
Much Worse
|
0 Participants
|
|
Clinical Global Impression of Change
Very Much Worse
|
0 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Number of participants with data available.
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.
Outcome measures
| Measure |
Tapentadol PR
n=194 Participants
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.
|
|---|---|
|
Participant's Satisfaction With Previous Analgesic Treatment
Excellent
|
0 participants
|
|
Participant's Satisfaction With Previous Analgesic Treatment
Very Good
|
0 participants
|
|
Participant's Satisfaction With Previous Analgesic Treatment
Good
|
4 participants
|
|
Participant's Satisfaction With Previous Analgesic Treatment
Fair
|
132 participants
|
|
Participant's Satisfaction With Previous Analgesic Treatment
Poor
|
62 participants
|
SECONDARY outcome
Timeframe: Baseline; End of Week 6 (6 Weeks)Population: Number of participants with data available
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.
Outcome measures
| Measure |
Tapentadol PR
n=160 Participants
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.
|
|---|---|
|
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
Excellent
|
16 participants
|
|
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
Very Good
|
39 participants
|
|
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
Good
|
88 participants
|
|
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
Fair
|
17 participants
|
|
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
Poor
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline; End of Week 12 (12 Weeks)Population: Number of participants with data available
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.
Outcome measures
| Measure |
Tapentadol PR
n=125 Participants
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.
|
|---|---|
|
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
Excellent
|
16 participants
|
|
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
Very Good
|
45 participants
|
|
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
Good
|
54 participants
|
|
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
Fair
|
9 participants
|
|
Participant's Satisfaction With New Analgesic Treatment, i.e Tapentadol.
Poor
|
1 participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Number of participants with data available
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.
Outcome measures
| Measure |
Tapentadol PR
n=195 Participants
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.
|
|---|---|
|
Baseline Western Ontario McMaster Questionnaire (WOMAC) Global Score Assessing Pain, Disability and Joint Stiffness of the Knee
|
53.6 units on a scale
Standard Deviation 14.58
|
SECONDARY outcome
Timeframe: Baseline; End of Week 6 (6 Weeks)Population: Number of participants with data available
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.
Outcome measures
| Measure |
Tapentadol PR
n=159 Participants
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.
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|---|---|
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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
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-21.0 units on a scale
Standard Deviation 18.82
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SECONDARY outcome
Timeframe: Baseline; End of Week 12 (12 Weeks)Population: Number of participants with data available
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.
Outcome measures
| Measure |
Tapentadol PR
n=125 Participants
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.
|
|---|---|
|
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
|
-27.6 units on a scale
Standard Deviation 19.52
|
Adverse Events
Tapentadol PR
Serious adverse events
| Measure |
Tapentadol PR
n=200 participants at risk
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.
|
|---|---|
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Cardiac disorders
Angina unstable
|
0.50%
1/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
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Cardiac disorders
Myocardial infarction
|
0.50%
1/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Infections and infestations
Cellulitis
|
0.50%
1/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.50%
1/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Infections and infestations
Urinary tract infection
|
0.50%
1/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.50%
1/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.50%
1/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Nervous system disorders
Facial palsy
|
0.50%
1/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Psychiatric disorders
Panic attack
|
0.50%
1/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Vascular disorders
Deep vein thrombosis
|
0.50%
1/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
Other adverse events
| Measure |
Tapentadol PR
n=200 participants at risk
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.
|
|---|---|
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Gastrointestinal disorders
Constipation
|
10.5%
21/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.5%
11/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
10.0%
20/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Gastrointestinal disorders
Nausea
|
13.0%
26/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
10/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
General disorders
Fatigue
|
10.5%
21/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
16/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Nervous system disorders
Dizziness
|
12.0%
24/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Nervous system disorders
Headache
|
6.5%
13/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
|
|
Nervous system disorders
Somnolence
|
7.0%
14/200 • From first tapentadol dose to the end of week 12 of tapentadol treatment.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER