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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

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ClinicalTrials.gov Identifier: NCT00814580
Recruitment Status : Completed
First Posted : December 25, 2008
Results First Posted : January 10, 2012
Last Update Posted : November 20, 2012
Sponsor:
Collaborator:
Grünenthal GmbH
Information provided by (Responsible Party):
Ortho-McNeil Janssen Scientific Affairs, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Postoperative Pain
Interventions Drug: Tapentadol IR
Drug: Oxycodone IR
Enrollment 382
Recruitment Details The recruitment period for this outpatient, multicenter US only study occurred between Jan. 14, 2009 and Mar. 19, 2010
Pre-assignment Details 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).
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description 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 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
Period Title: Overall Study
Started 194 188
Completed 163 141
Not Completed 31 47
Reason Not Completed
Adverse Event             6             15
Lack of Efficacy             18             25
Protocol Violation             2             0
Withdrawal by Subject             2             2
Other             1             3
Did Not Take Drug             2             2
Arm/Group Title Tapentadol IR Oxycodone IR Total
Hide Arm/Group Description 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 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 of all reporting groups
Overall Number of Baseline Participants 192 186 378
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants 186 participants 378 participants
<=18 years
4
   2.1%
6
   3.2%
10
   2.6%
Between 18 and 65 years
138
  71.9%
137
  73.7%
275
  72.8%
>=65 years
50
  26.0%
43
  23.1%
93
  24.6%
[1]
Measure Description: The summary statistics provided for baseline characteristic was based on safety population that includes 192 subjects in tapentadol group and 186 subjects in oxycodone group. The safety population includes randomized subjects took at least one dose of study drug.
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 192 participants 186 participants 378 participants
53.2  (14.98) 52.7  (14.97) 52.9  (14.96)
[1]
Measure Description: The summary statistics provided for baseline characteristic was based on safety population that includes 192 subjects in tapentadol group and 186 subjects in oxycodone group. The safety population includes randomized subjects took at least one dose of study drug.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 192 participants 186 participants 378 participants
Female
69
  35.9%
58
  31.2%
127
  33.6%
Male
123
  64.1%
128
  68.8%
251
  66.4%
[1]
Measure Description: The summary statistics provided for baseline characteristic was based on safety population that includes 192 subjects in tapentadol group and 186 subjects in oxycodone group. The safety population includes randomized subjects took at least one dose of study drug.
Region of Enrollment   [1] 
Measure Type: Number
Unit of measure:  Participants
USA Number Analyzed 192 participants 186 participants 378 participants
192 186 378
[1]
Measure Description: The summary statistics provided for baseline characteristic was based on safety population that includes 192 subjects in tapentadol group and 186 subjects in oxycodone group. The safety population includes randomized subjects took at least one dose of study drug.
1.Primary Outcome
Title Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 3 Days (72 Hours)
Hide Description 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.
Time Frame 3 Days (72 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
34.8  (134.18) 40.5  (155.41)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments Tapentadol IR versus Oxycodone IR
Type of Statistical Test Non-Inferiority or Equivalence
Comments Primary hypothesis test for non-inferiority of tapentadol IR over oxycodone IR required that upper limit of 95% CI for LS mean difference (oxycodone IR minus tapentadol IR) was less than the inferiority margin (< 72). If the upper limit was less than 0 then tapentadol IR was superior to oxycodone IR for SPID over 3 days at a 5% level of significance.
Statistical Test of Hypothesis P-Value 0.5265
Comments Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 9.0
Confidence Interval (2-Sided) 95%
-18.9 to 36.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 14.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Summary of Kaplan-Meier Estimates for Time to Achieve 50% Reduction in Pain Intensity From Baseline
Hide Description 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.
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Median (95% Confidence Interval)
Unit of Measure: Hours
125.3 [1] 
(100.3 to NA)
NA [1] 
(99.9 to NA)
[1]
NA: Not Applicable, as not enough participants achieved 50% pain reduction and upper limit of confidence interval.
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7306
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
3.Secondary Outcome
Title Summary of Kaplan-Meier Estimates for Time to Achieve 30% Reduction in Pain Intensity From Baseline
Hide Description 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.
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Median (95% Confidence Interval)
Unit of Measure: Hours
73.9
(54.5 to 89.0)
66.4
(46.0 to 134.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.8524
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
4.Secondary Outcome
Title Summary of 30% Responder Rate (With Imputation) on Day 3
Hide Description 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.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Measure Type: Number
Unit of Measure: percentage of participants
33.5 34.4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9078
Comments Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
5.Secondary Outcome
Title Summary of 30% Responder Rate (With Imputation) on Day 7
Hide Description 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.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Measure Type: Number
Unit of Measure: percentage of participants
48.1 42.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2633
Comments Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
6.Secondary Outcome
Title Summary of 50% Responder Rate (With Imputation) on Day 3
Hide Description 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.
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Measure Type: Number
Unit of Measure: percentage of participants
19.0 22.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4498
Comments Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
7.Secondary Outcome
Title Summary of 50% Responder Rate (With Imputation) on Day 7
Hide Description 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.
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Modified Intent-to-Treat Population
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Measure Type: Number
Unit of Measure: percentage of participants
35.4 29.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2158
Comments Cochran-Mantel-Haenszel test (Row Mean Score option) controlling for pooled investigator centers.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
8.Secondary Outcome
Title Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 2 Days (48 Hours)
Hide Description 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.
Time Frame 2 Days (48 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
10.6  (88.05) 14.6  (102.24)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.4811
Comments Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 6.6
Confidence Interval (2-Sided) 95%
-11.8 to 25.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 9.34
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Summary and Analysis of Sum of Pain Intensity Difference (SPID) (With Imputation) Over 7 Days
Hide Description 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.
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
136.1  (277.20) 122.1  (299.87)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7405
Comments Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -9.3
Confidence Interval (2-Sided) 95%
-64.7 to 46.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 28.13
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 2 Days (48 Hours)
Hide Description 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.
Time Frame 2 Days (48 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
97.7  (48.13) 92.0  (50.74)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3097
Comments Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -5.6
Confidence Interval (2-Sided) 95%
-16.5 to 5.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 5.53
Estimation Comments [Not Specified]
11.Secondary Outcome
Title Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 3 Days (72hours)
Hide Description 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.
Time Frame 3 Days (72hours)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
151.3  (71.9) 140.9  (77.39)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2179
Comments Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -10.3
Confidence Interval (2-Sided) 95%
-26.7 to 6.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 8.34
Estimation Comments [Not Specified]
12.Secondary Outcome
Title Summary and Analysis of Total Pain Relief (TOTPAR) (With Imputation) Over 7 Days
Hide Description 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.
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
299.1  (137.33) 272.9  (154.31)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1051
Comments Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -26.3
Confidence Interval (2-Sided) 95%
-58.1 to 5.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 16.16
Estimation Comments [Not Specified]
13.Secondary Outcome
Title Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 2 Days (48 Hours)
Hide Description 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.
Time Frame 2 Days (48 hours)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
108.2  (109.89) 106.6  (125.82)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9367
Comments Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value 1.0
Confidence Interval (2-Sided) 95%
-22.8 to 24.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 12.09
Estimation Comments [Not Specified]
14.Secondary Outcome
Title Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 3 Days (72 Hours)
Hide Description 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.
Time Frame 3 Days (72hours)
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
186.1  (168.64) 181.4  (193.97)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.9441
Comments Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -1.3
Confidence Interval (2-Sided) 95%
-37.8 to 35.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 18.53
Estimation Comments [Not Specified]
15.Secondary Outcome
Title Summary and Analysis of the Sum of Total Pain Relief and Sum of Pain Intensity Difference (SPRID) (With Imputation) Over 7 Days
Hide Description 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.
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
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).
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 158 154
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
435.2  (354.59) 395.0  (386.16)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.3427
Comments Analysis of covariance (ANCOVA) model included baseline pain intensity score as the covariate and treatment and pooled center as class variables.
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least square mean difference
Estimated Value -35.6
Confidence Interval (2-Sided) 95%
-109.3 to 38.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 37.45
Estimation Comments [Not Specified]
16.Secondary Outcome
Title Subject Satisfaction With Treatment
Hide Description Treatment satisfaction was measured using a 7-point scale where 1 = very satisfied and 7 = very dissatisfied
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 192 181
Measure Type: Number
Unit of Measure: percentage of participants
Very satisfied 58.3 48.1
Somewhat satisfied 15.6 20.4
Slightly satisfied 2.6 5.5
Neither satisfied nor dissatisfied 7.3 5.0
Slightly dissatisfied 3.6 3.3
Somewhat dissatisfied 2.1 1.7
Very dissatisfied 9.9 14.4
Missing 0.5 1.7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.1618
Comments Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
17.Secondary Outcome
Title Patient Global Impression of Change (PGIC) at End of Study
Hide Description Patient Global Impression of Change (PGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 192 181
Measure Type: Number
Unit of Measure: percentage of participants
Very much improved 27.6 26.0
Much improved 46.9 42.5
Minimally improved 15.6 13.3
No change 3.1 7.7
Minimally worse 2.1 2.2
Much worse 1.6 0.6
Very much worse 1.0 5.5
Missing 2.1 2.2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0481
Comments Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers.
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
18.Secondary Outcome
Title Clinician Global Impression of Change (CGIC) at End of Study
Hide Description Clinician Global Impression of Change (CGIC) was defined as the 7-point numeric scale, where 1=very much improved to 7=very much worse.
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 192 181
Measure Type: Number
Unit of Measure: percentage of participants
Very much improved 33.3 29.3
Much improved 47.4 39.8
Minimally improved 11.5 12.7
No change 3.6 7.2
Minimally worse 1.0 2.2
Much worse 1.0 1.1
Very much worse 1.0 5.0
Missing 1.0 2.8
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tapentadol IR, Oxycodone IR
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0109
Comments Cochran-Mantel-Haenszel test (row mean score option) controlling for pooled investigator centers
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
19.Secondary Outcome
Title Summary of Medical Resource Utilization - Number of Calls by the Subject to Study Site Personnel
Hide Description Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 192 181
Measure Type: Number
Unit of Measure: Number of calls
Total number of subjects who made calls 69 74
Number of adverse event related calls 39 28
Number of pain-related calls 46 70
Number of non-medical/administrative calls 16 19
Number of other medical conditions calls 10 7
Total number of calls 105 122
20.Secondary Outcome
Title Summary of Medical Resource Utilization - Number of Other Types of Contacts With Healthcare Professionals
Hide Description Information associated with contacts with a healthcare professional was collected by the investigator and study staff for all subjects throughout the study.
Time Frame 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description:
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 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 Number of Participants Analyzed 192 181
Measure Type: Number
Unit of Measure: Number of participants
Patients visited a healthcare professional 87 89
Number of patient with scheduled visits 84 85
Number of patient with unscheduled visits 7 6
Number of patient with Internist 2 1
Number of patient with Orthopedic surgeon 80 87
Number of patient with Physical therapist 3 0
Number of patient with Primary care physician 5 1
Patient with other healthcare professional 2 1
Number of patient with emergency room visit 6 6
Number of patient with hospital admissions 0 2
21.Secondary Outcome
Title Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Tapentadol IR participants at the baseline.
Tapentadol IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 63 56 35 35 192 3
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 34 34 20 16 104 0
Baseline: 1-2 Days 15 12 7 5 40 1
Baseline: 3-5 Days 8 6 4 6 26 2
Baseline: 6-7 Days 5 4 4 8 21 0
Baseline: Miss the measurement 1 0 0 0 1 0
22.Secondary Outcome
Title Sleep Quality: Trouble Falling Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Oxycodone IR participants at the baseline.
Oxycodone IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 67 45 33 32 181 4
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 44 23 21 14 105 3
Baseline: 1-2 Days 11 12 4 7 34 0
Baseline: 3-5 Days 7 8 3 5 24 1
Baseline: 6-7 Days 3 2 5 6 16 0
Baseline: Miss the measurement 2 0 0 0 2 0
23.Secondary Outcome
Title Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Tapentadol IR participants at the baseline.
Tapentadol IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 20 48 42 79 192 3
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 9 12 8 12 42 1
Baseline: 1-2 Days 2 12 8 13 35 0
Baseline: 3-5 Days 3 17 12 21 53 0
Baseline: 6-7 Days 5 7 14 33 61 2
Baseline: Miss the measurement 1 0 0 0 1 0
24.Secondary Outcome
Title Sleep Quality: Wake up Several Times During Night? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Oxycodone IR participants at the baseline.
Oxycodone IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 17 36 45 79 181 4
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 8 14 6 14 44 2
Baseline: 1-2 Days 5 7 11 23 46 0
Baseline: 3-5 Days 2 11 10 12 36 1
Baseline: 6-7 Days 2 3 18 29 53 1
Baseline: Miss the measurement 0 1 0 1 2 0
25.Secondary Outcome
Title Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Tapentadol IR participants at the baseline.
Tapentadol IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 50 47 45 47 192 3
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 27 24 17 13 81 0
Baseline: 1-2 Days 12 13 7 8 41 1
Baseline: 3-5 Days 5 3 13 9 31 1
Baseline: 6-7 Days 5 7 8 17 38 1
Baseline: Miss the measurement 1 0 0 0 1 0
26.Secondary Outcome
Title Sleep Quality: Trouble Staying Asleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Oxycodone IR participants at the baseline.
Oxycodone IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 46 40 34 57 181 4
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 26 17 12 20 77 2
Baseline: 1-2 Days 8 13 8 13 42 0
Baseline: 3-5 Days 5 6 7 9 29 2
Baseline: 6-7 Days 6 3 7 14 30 0
Baseline: Miss the measurement 1 1 0 1 3 0
27.Secondary Outcome
Title Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Tapentadol IR participants at the baseline.
Tapentadol IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 50 59 46 34 192 3
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 23 17 13 2 56 1
Baseline: 1-2 Days 13 17 9 5 46 2
Baseline: 3-5 Days 6 15 10 7 38 0
Baseline: 6-7 Days 7 10 14 20 51 0
Baseline: Miss the measurement 1 0 0 0 1 0
28.Secondary Outcome
Title Sleep Quality: Pain Interferes With Sleep? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Oxycodone IR participants at the baseline.
Oxycodone IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 27 52 50 48 181 4
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 16 15 15 9 57 2
Baseline: 1-2 Days 4 11 15 6 37 1
Baseline: 3-5 Days 3 16 6 5 31 1
Baseline: 6-7 Days 4 8 14 28 54 0
Baseline: Miss the measurement 0 2 0 0 2 0
29.Secondary Outcome
Title Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Tapentadol IR participants at the baseline.
Tapentadol IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 53 51 47 38 192 3
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 35 19 8 9 71 0
Baseline: 1-2 Days 8 16 17 6 49 2
Baseline: 3-5 Days 4 10 14 8 36 0
Baseline: 6-7 Days 5 6 8 15 35 1
Baseline: Miss the measurement 1 0 0 0 1 0
30.Secondary Outcome
Title Sleep Quality: Wake up Feeling Tired and Worn Out? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Oxycodone IR participants at the baseline.
Oxycodone IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 51 46 44 36 181 4
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 28 23 20 8 82 3
Baseline: 1-2 Days 14 12 13 9 48 0
Baseline: 3-5 Days 3 8 6 6 24 1
Baseline: 6-7 Days 4 3 5 13 25 0
Baseline: Miss the measurement 2 0 0 0 2 0
31.Secondary Outcome
Title Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Tapentadol IR participants at the baseline.
Tapentadol IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 16 41 63 69 192 3
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 3 6 3 11 23 0
Baseline: 1-2 Days 1 6 8 9 24 0
Baseline: 3-5 Days 7 10 14 10 41 0
Baseline: 6-7 Days 5 19 38 38 103 3
Baseline: Miss the measurement 0 0 0 1 1 0
32.Secondary Outcome
Title Sleep Quality: Feeling Alert During Daytime Hours? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Oxycodone IR participants at the baseline.
Oxycodone IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 24 31 51 71 181 4
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 5 3 4 12 25 1
Baseline: 1-2 Days 2 5 9 3 20 1
Baseline: 3-5 Days 3 6 13 12 34 0
Baseline: 6-7 Days 14 17 25 42 100 2
Baseline: Miss the measurement 0 0 0 2 2 0
33.Secondary Outcome
Title Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Tapentadol IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Tapentadol IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Tapentadol IR participants who chose category of 'Not at all' for the measurement at the end of study.
Tapentadol IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Tapentadol IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Tapentadol IR participants at the baseline.
Tapentadol IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 36 35 59 59 192 3
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 11 7 9 11 39 1
Baseline: 1-2 Days 9 9 9 7 34 0
Baseline: 3-5 Days 7 13 20 14 55 1
Baseline: 6-7 Days 9 6 21 26 63 1
Baseline: Miss the measurement 0 0 0 1 1 0
34.Secondary Outcome
Title Sleep Quality: Feeling Well Rested? - Shift of Measurement From Baseline to End of Study (Oxycodone IR)
Hide Description 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).
Time Frame Baseline and 7 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Oxycodone IR arm of Intent-to-Treat population. Shift table from baseline to end of study (Day 7).
Arm/Group Title End of Study: Not at All End of Study: 1-2 Days End of Study: 3-5 Days End of Study: 6-7 Days Baseline - Total End of Study: Missing the Measurement
Hide Arm/Group Description:
Oxycodone IR participants who chose category of 'Not at all' for the measurement at the end of study.
Oxycodone IR participants who chose category of '1-2 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '3-5 Days' for the measurement at the end of study.
Oxycodone IR participants who chose category of '6-7 Days' for the measurement at the end of study.
Total Oxycodone IR participants at the baseline.
Oxycodone IR Participants who missed the measurement at the end of study.
Overall Number of Participants Analyzed 34 44 45 54 181 4
Measure Type: Number
Unit of Measure: participants
Baseline: Not at all 10 6 4 6 27 1
Baseline: 1-2 Days 4 11 11 5 32 1
Baseline: 3-5 Days 9 14 14 13 50 0
Baseline: 6-7 Days 11 13 15 29 70 2
Baseline: Miss the measurement 0 0 1 1 2 0
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tapentadol IR Oxycodone IR
Hide Arm/Group Description 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 5 or 10 mg 4-6 hours as needed, maximum 60 mg a day for 7 days but can be up to 9 days
All-Cause Mortality
Tapentadol IR Oxycodone IR
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Tapentadol IR Oxycodone IR
Affected / at Risk (%) Affected / at Risk (%)
Total   0/192 (0.00%)   3/186 (1.61%) 
Cardiac disorders     
Atrial Fibrillation * 1  0/192 (0.00%)  1/186 (0.54%) 
General disorders     
Pain * 1  0/192 (0.00%)  1/186 (0.54%) 
Vascular disorders     
Deep Vein Thrombosis * 1  0/192 (0.00%)  1/186 (0.54%) 
Thrombophlebitis Superficial * 1  0/192 (0.00%)  1/186 (0.54%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tapentadol IR Oxycodone IR
Affected / at Risk (%) Affected / at Risk (%)
Total   83/192 (43.23%)   75/186 (40.32%) 
Gastrointestinal disorders     
Vomiting * 1  36/192 (18.75%)  19/186 (10.22%) 
Nausea * 1  33/192 (17.19%)  30/186 (16.13%) 
Constipation * 1  17/192 (8.85%)  27/186 (14.52%) 
Nervous system disorders     
Headache * 1  18/192 (9.38%)  14/186 (7.53%) 
Skin and subcutaneous tissue disorders     
Pruritus * 1  12/192 (6.25%)  15/186 (8.06%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 11.1
No notable study limitations were identified by the Sponsor
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Director of Clinical Development, Pain
Organization: Ortho-McNeil Janssen Scientific Affair, LLC
Phone: (908)927-5469
EMail: GVorsang@its.jnj.com
Layout table for additonal information
Responsible Party: Ortho-McNeil Janssen Scientific Affairs, LLC
ClinicalTrials.gov Identifier: NCT00814580    
Other Study ID Numbers: CR015040
R331333PAI3022 ( Other Identifier: Ortho-McNeil Janssen Scientific Affairs, LLC )
KF5503/49 ( Other Identifier: Grunenthal GmbH )
First Submitted: December 23, 2008
First Posted: December 25, 2008
Results First Submitted: March 10, 2011
Results First Posted: January 10, 2012
Last Update Posted: November 20, 2012