Trial Outcomes & Findings for Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute Post-op Pain Following Elective Arthroscopic (Surgery Using a Thin Flexible Scope) Shoulder Surgery (NCT NCT00814580)
NCT ID: NCT00814580
Last Updated: 2012-11-20
Results Overview
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.
COMPLETED
PHASE3
382 participants
3 Days (72 hours)
2012-11-20
Participant Flow
The recruitment period for this outpatient, multicenter US only study occurred between Jan. 14, 2009 and Mar. 19, 2010
The study consisted of a screening period (up to 21 days) and a double-blind active treatment period (7 days, but can be up to 9 days).
Participant milestones
| Measure |
Tapentadol IR
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
|---|---|---|
|
Overall Study
STARTED
|
194
|
188
|
|
Overall Study
COMPLETED
|
163
|
141
|
|
Overall Study
NOT COMPLETED
|
31
|
47
|
Reasons for withdrawal
| Measure |
Tapentadol IR
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
|---|---|---|
|
Overall Study
Adverse Event
|
6
|
15
|
|
Overall Study
Lack of Efficacy
|
18
|
25
|
|
Overall Study
Protocol Violation
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Other
|
1
|
3
|
|
Overall Study
Did Not Take Drug
|
2
|
2
|
Baseline Characteristics
Safety and Efficacy of Tapentadol Immediate Release (IR) and Oxycodone IR for Treatment of Acute Post-op Pain Following Elective Arthroscopic (Surgery Using a Thin Flexible Scope) Shoulder Surgery
Baseline characteristics by cohort
| Measure |
Tapentadol IR
n=192 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=186 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
Total
n=378 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
138 Participants
n=5 Participants
|
137 Participants
n=7 Participants
|
275 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
50 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
|
Age Continuous
|
53.2 years
STANDARD_DEVIATION 14.98 • n=5 Participants
|
52.7 years
STANDARD_DEVIATION 14.97 • n=7 Participants
|
52.9 years
STANDARD_DEVIATION 14.96 • n=5 Participants
|
|
Sex: Female, Male
Female
|
69 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
123 Participants
n=5 Participants
|
128 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Region of Enrollment
USA
|
192 participants
n=5 Participants
|
186 participants
n=7 Participants
|
378 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 Days (72 hours)Population: The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score \>= 4 on an 11-point numeric rating scale (NRS).
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID72 was calculated as the time-weighted Sum of PID scores over 72 hours. The range of SPID72 is from -720 to 720. The higher value in SPID indicates greater pain relief.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)
|
34.8 Scores on a scale
Standard Deviation 134.18
|
40.5 Scores on a scale
Standard Deviation 155.41
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Modified Intent-to-Treat Population
From date of first administration of study medication to time to achieve adequate 50% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 50% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline
|
125.3 Hours
Interval 100.3 to
NA: Not Applicable, as not enough participants achieved 50% pain reduction and upper limit of confidence interval.
|
NA Hours
Interval 99.9 to
NA: Not Applicable, as not enough participants achieved 50% pain reduction and upper limit of confidence interval.
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Modified Intent-to-Treat Population
From date of first administration of study medication to time to achieve adequate 30% reduction in pain intensity from baseline score. Censored observations included subjects who completed or discontinued from the study without a 30% reduction in pain intensity from baseline score. If a subject discontinued due to lack of efficacy (including rescue medication), the subject was censored on Day 7, 12 PM.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline
|
73.9 Hours
Interval 54.5 to 89.0
|
66.4 Hours
Interval 46.0 to 134.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 3Population: Modified Intent-to-Treat Population
The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then Baseline Observation Carried Forward (BOCF) will be imputed. Last Observation Carried Forward (LOCF) may be used if no value afterward.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary of 30% Responder Rate (With Imputation) on Day 3
|
33.5 percentage of participants
|
34.4 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: Modified Intent-to-Treat Population
The 30% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 30% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary of 30% Responder Rate (With Imputation) on Day 7
|
48.1 percentage of participants
|
42.2 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 3Population: Modified Intent-to-Treat Population
The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 3 (average of Day 3 PM and Day 4 AM). If a subject has only the Day 3 PM value or Day 4 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 3 PM then BOCF will be imputed. LOCF may be used if no value afterward.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary of 50% Responder Rate (With Imputation) on Day 3
|
19.0 percentage of participants
|
22.7 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 7Population: Modified Intent-to-Treat Population
The 50% responder rate was defined as the proportion of participants with a value of percentage change greater than or equal to the 50% from baseline in pain intensity at Day 7 (average of Day 6 PM and Day 7 AM). If a subject has only the Day 6 PM value or Day 7 AM value, then response rate will be based on the non-missing value. If a subject withdraws or uses rescue medication before Day 6 PM then BOCF will be imputed. LOCF may be used if no value afterward.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary of 50% Responder Rate (With Imputation) on Day 7
|
35.4 percentage of participants
|
29.2 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 Days (48 hours)Population: The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score \>= 4 on an 11-point numeric rating scale (NRS).
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID48 was calculated as the time-weighted Sum of PID scores over 48 hours. The range of SPID48 is from -480 to 480. The higher value in SPID indicates greater pain relief.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 2 Days (48 Hours)
|
10.6 Scores on a scale
Standard Deviation 88.05
|
14.6 Scores on a scale
Standard Deviation 102.24
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score \>= 4 on an 11-point numeric rating scale (NRS).
Pain Intensity (PI) was assessed on 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Pain Intensity Difference (PID) was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID over 7 Days was calculated as the time-weighted Sum of PID scores up to Day 7, 8 AM. The range is from -1440 to 1440. The higher value in SPID indicates greater pain relief.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 7 Days
|
136.1 Scores on a scale
Standard Deviation 277.20
|
122.1 Scores on a scale
Standard Deviation 299.87
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 Days (48 hours)Population: The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score \>= 4 on an 11-point numeric rating scale (NRS).
Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 48. The range of TOTPAR over 2 days is from 0 to 192. A higher value in TOTPAR indicated greater pain relief.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 2 Days (48 Hours)
|
97.7 Scores on a scale
Standard Deviation 48.13
|
92.0 Scores on a scale
Standard Deviation 50.74
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 Days (72hours)Population: The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score \>= 4 on an 11-point numeric rating scale (NRS).
Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to hour 72. The range of TOTPAR over 3 days is from 0 to 288. A higher value in TOTPAR indicated greater pain relief.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 3 Days (72hours)
|
151.3 Scores on a scale
Standard Deviation 71.9
|
140.9 Scores on a scale
Standard Deviation 77.39
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score \>= 4 on an 11-point numeric rating scale (NRS).
Pain Relief was defined as a 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Total Pain Relief (TOTPAR) was calculated as the time-weighted sum over all pain relief up to Day 7, 8 AM. The range of TOTPAR over 7 days is from 0 to 576. A higher value in TOTPAR indicated greater pain relief.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 7 Days
|
299.1 Scores on a scale
Standard Deviation 137.33
|
272.9 Scores on a scale
Standard Deviation 154.31
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 Days (48 hours)Population: The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score \>= 4 on an 11-point numeric rating scale (NRS).
The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 2 days is from -480 to 672. A higher value in SPRID indicated greater pain relief.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 2 Days (48 Hours)
|
108.2 Scores on a scale
Standard Deviation 109.89
|
106.6 Scores on a scale
Standard Deviation 125.82
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 3 Days (72hours)Population: The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score \>= 4 on an 11-point numeric rating scale (NRS).
The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 3 days is from -720 to 1008. A higher value in SPRID indicated greater pain relief.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 3 Days (72 Hours)
|
186.1 Scores on a scale
Standard Deviation 168.64
|
181.4 Scores on a scale
Standard Deviation 193.97
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: The modified Intent-to-Treat(mITT) population was defined as all randomized subjects who took at least one dose of study drug within 24 hours of randomization and had a baseline pain intensity score \>= 4 on an 11-point numeric rating scale (NRS).
The Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) was derived from Sum of TOTPAR and SPID. The range of SPRID over 7 days is from -1440 to 2016. A higher value in SPRID indicated greater pain relief.
Outcome measures
| Measure |
Tapentadol IR
n=158 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=154 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 7 Days
|
435.2 Scores on a scale
Standard Deviation 354.59
|
395.0 Scores on a scale
Standard Deviation 386.16
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Intent-to-Treat Population
Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied
Outcome measures
| Measure |
Tapentadol IR
n=192 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=181 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Subject Satisfaction With Treatment
Very satisfied
|
58.3 percentage of participants
|
48.1 percentage of participants
|
—
|
—
|
—
|
—
|
|
Subject Satisfaction With Treatment
Somewhat satisfied
|
15.6 percentage of participants
|
20.4 percentage of participants
|
—
|
—
|
—
|
—
|
|
Subject Satisfaction With Treatment
Slightly satisfied
|
2.6 percentage of participants
|
5.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Subject Satisfaction With Treatment
Neither satisfied nor dissatisfied
|
7.3 percentage of participants
|
5.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Subject Satisfaction With Treatment
Slightly dissatisfied
|
3.6 percentage of participants
|
3.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Subject Satisfaction With Treatment
Somewhat dissatisfied
|
2.1 percentage of participants
|
1.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Subject Satisfaction With Treatment
Very dissatisfied
|
9.9 percentage of participants
|
14.4 percentage of participants
|
—
|
—
|
—
|
—
|
|
Subject Satisfaction With Treatment
Missing
|
0.5 percentage of participants
|
1.7 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Intent-to-Treat Population
Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.
Outcome measures
| Measure |
Tapentadol IR
n=192 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=181 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Patient Global Impression of Change (PGIC) at End of Study
Very much improved
|
27.6 percentage of participants
|
26.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Patient Global Impression of Change (PGIC) at End of Study
Much improved
|
46.9 percentage of participants
|
42.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Patient Global Impression of Change (PGIC) at End of Study
Minimally improved
|
15.6 percentage of participants
|
13.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Patient Global Impression of Change (PGIC) at End of Study
No change
|
3.1 percentage of participants
|
7.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Patient Global Impression of Change (PGIC) at End of Study
Minimally worse
|
2.1 percentage of participants
|
2.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Patient Global Impression of Change (PGIC) at End of Study
Much worse
|
1.6 percentage of participants
|
0.6 percentage of participants
|
—
|
—
|
—
|
—
|
|
Patient Global Impression of Change (PGIC) at End of Study
Very much worse
|
1.0 percentage of participants
|
5.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Patient Global Impression of Change (PGIC) at End of Study
Missing
|
2.1 percentage of participants
|
2.2 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Intent-to-Treat Population
Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.
Outcome measures
| Measure |
Tapentadol IR
n=192 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=181 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Clinician Global Impression of Change (CGIC) at End of Study
Very much improved
|
33.3 percentage of participants
|
29.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinician Global Impression of Change (CGIC) at End of Study
Much improved
|
47.4 percentage of participants
|
39.8 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinician Global Impression of Change (CGIC) at End of Study
Minimally improved
|
11.5 percentage of participants
|
12.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinician Global Impression of Change (CGIC) at End of Study
No change
|
3.6 percentage of participants
|
7.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinician Global Impression of Change (CGIC) at End of Study
Minimally worse
|
1.0 percentage of participants
|
2.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinician Global Impression of Change (CGIC) at End of Study
Much worse
|
1.0 percentage of participants
|
1.1 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinician Global Impression of Change (CGIC) at End of Study
Very much worse
|
1.0 percentage of participants
|
5.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Clinician Global Impression of Change (CGIC) at End of Study
Missing
|
1.0 percentage of participants
|
2.8 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Intent-to-Treat Population
Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.
Outcome measures
| Measure |
Tapentadol IR
n=192 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=181 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel
Total number of subjects who made calls
|
69 Number of calls
|
74 Number of calls
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel
Number of adverse event related calls
|
39 Number of calls
|
28 Number of calls
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel
Number of pain-related calls
|
46 Number of calls
|
70 Number of calls
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel
Number of non-medical/administrative calls
|
16 Number of calls
|
19 Number of calls
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel
Number of other medical conditions calls
|
10 Number of calls
|
7 Number of calls
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel
Total number of calls
|
105 Number of calls
|
122 Number of calls
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 7 DaysPopulation: Intent-to-Treat Population
Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.
Outcome measures
| Measure |
Tapentadol IR
n=192 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=181 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Patients visited a healthcare professional
|
87 Number of participants
|
89 Number of participants
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Number of patient with scheduled visits
|
84 Number of participants
|
85 Number of participants
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Number of patient with unscheduled visits
|
7 Number of participants
|
6 Number of participants
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Number of patient with Internist
|
2 Number of participants
|
1 Number of participants
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Number of patient with Orthopedic surgeon
|
80 Number of participants
|
87 Number of participants
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Number of patient with Physical therapist
|
3 Number of participants
|
0 Number of participants
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Number of patient with Primary care physician
|
5 Number of participants
|
1 Number of participants
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Patient with other healthcare professional
|
2 Number of participants
|
1 Number of participants
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Number of patient with emergency room visit
|
6 Number of participants
|
6 Number of participants
|
—
|
—
|
—
|
—
|
|
Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Number of patient with hospital admissions
|
0 Number of participants
|
2 Number of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "trouble falling asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=63 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=56 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=35 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=35 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=192 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=3 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Not at all
|
34 participants
|
34 participants
|
20 participants
|
16 participants
|
104 participants
|
0 participants
|
|
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 1-2 Days
|
15 participants
|
12 participants
|
7 participants
|
5 participants
|
40 participants
|
1 participants
|
|
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 3-5 Days
|
8 participants
|
6 participants
|
4 participants
|
6 participants
|
26 participants
|
2 participants
|
|
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 6-7 Days
|
5 participants
|
4 participants
|
4 participants
|
8 participants
|
21 participants
|
0 participants
|
|
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Miss the measurement
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "trouble falling asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=67 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=45 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=33 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=32 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=181 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=4 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Not at all
|
44 participants
|
23 participants
|
21 participants
|
14 participants
|
105 participants
|
3 participants
|
|
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 1-2 Days
|
11 participants
|
12 participants
|
4 participants
|
7 participants
|
34 participants
|
0 participants
|
|
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 3-5 Days
|
7 participants
|
8 participants
|
3 participants
|
5 participants
|
24 participants
|
1 participants
|
|
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 6-7 Days
|
3 participants
|
2 participants
|
5 participants
|
6 participants
|
16 participants
|
0 participants
|
|
Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Miss the measurement
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "Wake up several times during night" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=20 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=48 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=42 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=79 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=192 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=3 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Not at all
|
9 participants
|
12 participants
|
8 participants
|
12 participants
|
42 participants
|
1 participants
|
|
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 1-2 Days
|
2 participants
|
12 participants
|
8 participants
|
13 participants
|
35 participants
|
0 participants
|
|
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 3-5 Days
|
3 participants
|
17 participants
|
12 participants
|
21 participants
|
53 participants
|
0 participants
|
|
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 6-7 Days
|
5 participants
|
7 participants
|
14 participants
|
33 participants
|
61 participants
|
2 participants
|
|
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Miss the measurement
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "Wake up several times during night" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=17 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=36 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=45 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=79 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=181 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=4 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Not at all
|
8 participants
|
14 participants
|
6 participants
|
14 participants
|
44 participants
|
2 participants
|
|
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 1-2 Days
|
5 participants
|
7 participants
|
11 participants
|
23 participants
|
46 participants
|
0 participants
|
|
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 3-5 Days
|
2 participants
|
11 participants
|
10 participants
|
12 participants
|
36 participants
|
1 participants
|
|
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 6-7 Days
|
2 participants
|
3 participants
|
18 participants
|
29 participants
|
53 participants
|
1 participants
|
|
Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Miss the measurement
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "Trouble staying asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=50 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=47 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=45 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=47 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=192 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=3 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 6-7 Days
|
5 participants
|
7 participants
|
8 participants
|
17 participants
|
38 participants
|
1 participants
|
|
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Miss the measurement
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Not at all
|
27 participants
|
24 participants
|
17 participants
|
13 participants
|
81 participants
|
0 participants
|
|
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 1-2 Days
|
12 participants
|
13 participants
|
7 participants
|
8 participants
|
41 participants
|
1 participants
|
|
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 3-5 Days
|
5 participants
|
3 participants
|
13 participants
|
9 participants
|
31 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "Trouble staying asleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=46 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=40 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=34 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=57 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=181 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=4 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Not at all
|
26 participants
|
17 participants
|
12 participants
|
20 participants
|
77 participants
|
2 participants
|
|
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 1-2 Days
|
8 participants
|
13 participants
|
8 participants
|
13 participants
|
42 participants
|
0 participants
|
|
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 3-5 Days
|
5 participants
|
6 participants
|
7 participants
|
9 participants
|
29 participants
|
2 participants
|
|
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 6-7 Days
|
6 participants
|
3 participants
|
7 participants
|
14 participants
|
30 participants
|
0 participants
|
|
Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Miss the measurement
|
1 participants
|
1 participants
|
0 participants
|
1 participants
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "Pain interferes with sleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=50 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=59 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=46 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=34 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=192 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=3 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Not at all
|
23 participants
|
17 participants
|
13 participants
|
2 participants
|
56 participants
|
1 participants
|
|
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 1-2 Days
|
13 participants
|
17 participants
|
9 participants
|
5 participants
|
46 participants
|
2 participants
|
|
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 3-5 Days
|
6 participants
|
15 participants
|
10 participants
|
7 participants
|
38 participants
|
0 participants
|
|
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 6-7 Days
|
7 participants
|
10 participants
|
14 participants
|
20 participants
|
51 participants
|
0 participants
|
|
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Miss the measurement
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "Pain interferes with sleep" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=27 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=52 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=50 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=48 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=181 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=4 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Not at all
|
16 participants
|
15 participants
|
15 participants
|
9 participants
|
57 participants
|
2 participants
|
|
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 1-2 Days
|
4 participants
|
11 participants
|
15 participants
|
6 participants
|
37 participants
|
1 participants
|
|
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 3-5 Days
|
3 participants
|
16 participants
|
6 participants
|
5 participants
|
31 participants
|
1 participants
|
|
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 6-7 Days
|
4 participants
|
8 participants
|
14 participants
|
28 participants
|
54 participants
|
0 participants
|
|
Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Miss the measurement
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "Wake up feeling tired and worn out" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=53 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=51 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=47 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=38 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=192 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=3 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Not at all
|
35 participants
|
19 participants
|
8 participants
|
9 participants
|
71 participants
|
0 participants
|
|
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 1-2 Days
|
8 participants
|
16 participants
|
17 participants
|
6 participants
|
49 participants
|
2 participants
|
|
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 3-5 Days
|
4 participants
|
10 participants
|
14 participants
|
8 participants
|
36 participants
|
0 participants
|
|
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 6-7 Days
|
5 participants
|
6 participants
|
8 participants
|
15 participants
|
35 participants
|
1 participants
|
|
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Miss the measurement
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "Wake up feeling tired and worn out" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=51 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=46 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=44 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=36 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=181 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=4 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Not at all
|
28 participants
|
23 participants
|
20 participants
|
8 participants
|
82 participants
|
3 participants
|
|
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 1-2 Days
|
14 participants
|
12 participants
|
13 participants
|
9 participants
|
48 participants
|
0 participants
|
|
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 3-5 Days
|
3 participants
|
8 participants
|
6 participants
|
6 participants
|
24 participants
|
1 participants
|
|
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 6-7 Days
|
4 participants
|
3 participants
|
5 participants
|
13 participants
|
25 participants
|
0 participants
|
|
Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Miss the measurement
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "Feeling alert during daytime hours" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=16 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=41 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=63 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=69 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=192 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=3 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Not at all
|
3 participants
|
6 participants
|
3 participants
|
11 participants
|
23 participants
|
0 participants
|
|
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 1-2 Days
|
1 participants
|
6 participants
|
8 participants
|
9 participants
|
24 participants
|
0 participants
|
|
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 3-5 Days
|
7 participants
|
10 participants
|
14 participants
|
10 participants
|
41 participants
|
0 participants
|
|
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 6-7 Days
|
5 participants
|
19 participants
|
38 participants
|
38 participants
|
103 participants
|
3 participants
|
|
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Miss the measurement
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "Feeling alert during daytime hours" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=24 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=31 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=51 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=71 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=181 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=4 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Not at all
|
5 participants
|
3 participants
|
4 participants
|
12 participants
|
25 participants
|
1 participants
|
|
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 1-2 Days
|
2 participants
|
5 participants
|
9 participants
|
3 participants
|
20 participants
|
1 participants
|
|
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 3-5 Days
|
3 participants
|
6 participants
|
13 participants
|
12 participants
|
34 participants
|
0 participants
|
|
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 6-7 Days
|
14 participants
|
17 participants
|
25 participants
|
42 participants
|
100 participants
|
2 participants
|
|
Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Miss the measurement
|
0 participants
|
0 participants
|
0 participants
|
2 participants
|
2 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "Feeling well rested" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=36 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=35 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=59 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=59 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=192 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=3 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Not at all
|
11 participants
|
7 participants
|
9 participants
|
11 participants
|
39 participants
|
1 participants
|
|
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 1-2 Days
|
9 participants
|
9 participants
|
9 participants
|
7 participants
|
34 participants
|
0 participants
|
|
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 3-5 Days
|
7 participants
|
13 participants
|
20 participants
|
14 participants
|
55 participants
|
1 participants
|
|
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: 6-7 Days
|
9 participants
|
6 participants
|
21 participants
|
26 participants
|
63 participants
|
1 participants
|
|
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Baseline: Miss the measurement
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Baseline and 7 DaysPopulation: Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Over the past 7 days patients reported "Feeling well rested" by using a 4-category scale (not at all, 1 to 2 days, 3 to 5 days, 6 to 7 days) at baseline and the final study visit (Day 7).
Outcome measures
| Measure |
Tapentadol IR
n=34 Participants
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=44 Participants
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
End of Study: 3-5 Days
n=45 Participants
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
|
End of Study: 6-7 Days
n=54 Participants
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
|
Baseline - Total
n=181 Participants
Total Tapentadol IR participants at the baseline.
|
End of Study: Missing the Measurement
n=4 Participants
Tapentadol IR Participants who missed the measurement at the end of study.
|
|---|---|---|---|---|---|---|
|
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Not at all
|
10 participants
|
6 participants
|
4 participants
|
6 participants
|
27 participants
|
1 participants
|
|
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 1-2 Days
|
4 participants
|
11 participants
|
11 participants
|
5 participants
|
32 participants
|
1 participants
|
|
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 3-5 Days
|
9 participants
|
14 participants
|
14 participants
|
13 participants
|
50 participants
|
0 participants
|
|
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: 6-7 Days
|
11 participants
|
13 participants
|
15 participants
|
29 participants
|
70 participants
|
2 participants
|
|
Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Baseline: Miss the measurement
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
0 participants
|
Adverse Events
Tapentadol IR
Oxycodone IR
Serious adverse events
| Measure |
Tapentadol IR
n=192 participants at risk
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=186 participants at risk
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
|---|---|---|
|
Cardiac disorders
Atrial Fibrillation
|
0.00%
0/192
|
0.54%
1/186
|
|
General disorders
Pain
|
0.00%
0/192
|
0.54%
1/186
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.00%
0/192
|
0.54%
1/186
|
|
Vascular disorders
Thrombophlebitis Superficial
|
0.00%
0/192
|
0.54%
1/186
|
Other adverse events
| Measure |
Tapentadol IR
n=192 participants at risk
Tapentadol IR 50 or 100 mg 4-6 hours as needed; maximum 600mg a day for 7 days but can be up 9 days
|
Oxycodone IR
n=186 participants at risk
Oxycodone IR 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
|
|---|---|---|
|
Gastrointestinal disorders
Vomiting
|
18.8%
36/192
|
10.2%
19/186
|
|
Gastrointestinal disorders
Nausea
|
17.2%
33/192
|
16.1%
30/186
|
|
Gastrointestinal disorders
Constipation
|
8.9%
17/192
|
14.5%
27/186
|
|
Nervous system disorders
Headache
|
9.4%
18/192
|
7.5%
14/186
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
6.2%
12/192
|
8.1%
15/186
|
Additional Information
Senior Director of Clinical Development, Pain
Ortho-McNeil Janssen Scientific Affair, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60