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A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01516008
Recruitment Status : Completed
First Posted : January 24, 2012
Results First Posted : April 28, 2014
Last Update Posted : April 28, 2014
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Care Provider);   Primary Purpose: Treatment
Condition Hallux Valgus
Interventions Drug: Tapentadol IR 50 mg
Drug: Tapentadol IR 75 mg
Drug: Placebo
Enrollment 353
Recruitment Details The study was conducted from 11 January 2012 to 2 February 2013. Participants were recruited at 17 study centers in Korea.
Pre-assignment Details 353 participants were randomly allocated to the 3 treatment arms. 352 participants received at least 1 dose of the study drug and were included in the intent-to-treat (ITT) analysis set.
Arm/Group Title Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Hide Arm/Group Description Each participant received matching placebo once every 4 to 6 hours for 3 days Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Period Title: Overall Study
Started 114 121 117
Completed 69 105 99
Not Completed 45 16 18
Reason Not Completed
Adverse Event             0             2             7
Lack of Efficacy             44             14             10
Protocol Violation             1             0             0
Reason not specified             0             0             1
Arm/Group Title Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg Total
Hide Arm/Group Description Each participant received matching placebo once every 4 to 6 hours for 3 days Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days Total of all reporting groups
Overall Number of Baseline Participants 114 121 117 352
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 114 participants 121 participants 117 participants 352 participants
51.3  (11.62) 51.8  (11.9) 50.7  (13.45) 51.3  (12.33)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 114 participants 121 participants 117 participants 352 participants
Female
109
  95.6%
114
  94.2%
108
  92.3%
331
  94.0%
Male
5
   4.4%
7
   5.8%
9
   7.7%
21
   6.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Korea, Republic Of Number Analyzed 114 participants 121 participants 117 participants 352 participants
114 121 117 352
Age Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 114 participants 121 participants 117 participants 352 participants
<65 years 103 105 99 307
>=65 years 11 16 18 45
1.Primary Outcome
Title Sum of Pain Intensity Differences (SPID) Over 48 Hours
Hide Description Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 48 hours. Total score ranges from -480 (worst) to 480 (best) for SPID48. A higher value of SPID indicates greater pain relief.
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.
Arm/Group Title Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Hide Arm/Group Description:
Each participant received matching placebo once every 4 to 6 hours for 3 days
Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Overall Number of Participants Analyzed 114 121 117
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
65.3  (121.04) 131.7  (107.19) 154.5  (124.03)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value adjusted for multiple treatment group comparisons using the Hochberg method.
Method ANCOVA
Comments ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 76.35
Confidence Interval (2-Sided) 95%
51.0 to 101.7
Estimation Comments Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value is adjusted for multiple treatment group comparisons using the Hochberg method.
Method ANCOVA
Comments ANCOVA model with treatment group and center as factors and baseline pain intensity as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 90.60
Confidence Interval (2-Sided) 95%
65.1 to 116.1
Estimation Comments Difference is SPID48 in tapentadol IR group minus SPID48 in placebo group.
2.Secondary Outcome
Title Time to First Rescue Medication Use
Hide Description Rescue medication was defined as any analgesic medication used for participants discontinued due to lack of efficacy (including those started at time of discontinuation) or analgesic medication used during the double-blind period for completed participants.
Time Frame Up to 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.
Arm/Group Title Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Hide Arm/Group Description:
Each participant received matching placebo once every 4 to 6 hours for 3 days
Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Overall Number of Participants Analyzed 114 121 117
Median (Inter-Quartile Range)
Unit of Measure: Hours
NA [1] 
(6.7 to NA)
NA [2] 
(NA to NA)
NA [3] 
(NA to NA)
[1]
The median time to the first rescue medication could not be calculated for the treatment group because less than 50 percent of participants (38.6 percent) used rescue medication.
[2]
The median time to the first rescue medication could not be calculated for the treatment group because less than 50 percent of participants (14.0 percent) used rescue medication.
[3]
The median time to the first rescue medication could not be calculated for the treatment group because less than 50 percent of participants (9.4 percent) used rescue medication.
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value adjusted for multiple treatment group comparisons using the Hochberg method.
Method Log Rank
Comments Stratified by center
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments P-value adjusted for multiple treatment group comparisons using the Hochberg method.
Method Log Rank
Comments Stratified by center
3.Secondary Outcome
Title Percent Reduction in Pain Intensity From Baseline at 12, 24, 48, and 72 Hours
Hide Description Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.
Time Frame Baseline (Day 1) and 12, 24, 48, and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.
Arm/Group Title Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Hide Arm/Group Description:
Each participant received matching placebo once every 4 to 6 hours for 3 days
Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Overall Number of Participants Analyzed 114 121 117
Median (Inter-Quartile Range)
Unit of Measure: Percentage Reduction
12 hours
0.0
(0.0 to 30.0)
28.6
(0.0 to 50.0)
28.6
(12.5 to 60.0)
24 hours
20.0
(0.0 to 50.0)
44.4
(22.2 to 60.0)
50.0
(25.0 to 71.4)
48 hours
41.4
(0.0 to 71.4)
66.7
(42.9 to 80.0)
70.0
(40 to 83.3)
72 hours
60.0
(0 to 85.7)
77.8
(57.1 to 90.0)
80.0
(50.0 to 90.0)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 12 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments Between-group comparison of cumulative distributions of percent reduction
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 12 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments Between-group comparison of cumulative distributions of percent reduction
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 24 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Log Rank
Comments Between-group comparison of cumulative distributions of percent reduction
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 24 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments Between-group comparison of cumulative distributions of percent reduction
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 48 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments Between-group comparison of cumulative distributions of percent reduction
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 48 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments Between-group comparison of cumulative distributions of percent reduction
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 72 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Log Rank
Comments Between-group comparison of cumulative distributions of percent reduction
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 72 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Log Rank
Comments Between-group comparison of cumulative distributions of percent reduction
4.Secondary Outcome
Title Response Rate for 30 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours
Hide Description Response rate was defined as the percentage of participants with a 30 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.
Time Frame 12, 24, 48, and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.
Arm/Group Title Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Hide Arm/Group Description:
Each participant received matching placebo once every 4 to 6 hours for 3 days
Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Overall Number of Participants Analyzed 114 121 117
Measure Type: Number
Unit of Measure: Percentage of participants
12 hours 27.2 47.9 49.6
24 hours 39.5 68.6 70.9
48 hours 53.5 79.3 76.9
72 hours 57.9 81.8 80.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 12 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 12 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 24 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 24 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 48 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 48 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 72 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 72 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
5.Secondary Outcome
Title Response Rate for 50 Percent or Greater Reduction in Pain Intensity at 12, 24, 48, and 72 Hours
Hide Description Response rate was defined as the percentage of participants with a 50 percent or greater reduction in pain intensity from baseline to 12, 24, 48, and 72 hours. Pain intensity was assessed on a 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. Participants with no assessment at the given time point, who used an analgesic medication prior to the time point, or who had worse pain intensity at the time point compared to baseline were assigned a percent reduction of 0 percent.
Time Frame 12, 24, 48, and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.
Arm/Group Title Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Hide Arm/Group Description:
Each participant received matching placebo once every 4 to 6 hours for 3 days
Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Overall Number of Participants Analyzed 114 121 117
Measure Type: Number
Unit of Measure: Percentage of participants
12 hours 11.4 28.9 32.5
24 hours 31.6 46.3 54.7
48 hours 48.2 71.1 70.1
72 hours 56.1 79.3 76.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 12 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 12 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 24 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 24 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 48 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 48 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 72 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 72 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
6.Secondary Outcome
Title Sum of Pain Intensity Differences (SPID) Over 12, 24, and 72 Hours
Hide Description Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. SPID was calculated as the time-weighted Sum of PID scores over 12, 24, and 72 hours. Total score ranges from -120 (worst) to 120 (best) for SPID12, -240 (worst) to 240 (best) for SPID24, -720 (worst) to 720 (best) for SPID72. A higher value of SPID indicates greater pain relief.
Time Frame 12, 24, and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.
Arm/Group Title Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Hide Arm/Group Description:
Each participant received matching placebo once every 4 to 6 hours for 3 days
Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Overall Number of Participants Analyzed 114 121 117
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
12 hours 5.7  (23.59) 20.4  (22.29) 24.6  (28.18)
24 hours 17.7  (51.88) 48.1  (47.92) 60.1  (58.56)
72 hours 127.9  (198.61) 234.5  (170.84) 264.1  (192.70)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 12 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 16.52
Confidence Interval (2-Sided) 95%
11.1 to 22.0
Estimation Comments Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 12 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 19.11
Confidence Interval (2-Sided) 95%
13.6 to 24.6
Estimation Comments Difference is SPID12 in tapentadol IR group minus SPID12 in placebo group.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 24 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 34.71
Confidence Interval (2-Sided) 95%
23.2 to 46.2
Estimation Comments Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 24 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 43.04
Confidence Interval (2-Sided) 95%
31.5 to 54.6
Estimation Comments Difference is SPID24 in tapentadol IR group minus SPID24 in placebo group.
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 72 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 122.32
Confidence Interval (2-Sided) 95%
81.8 to 162.9
Estimation Comments Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 72 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate.
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 138.57
Confidence Interval 95%
97.8 to 179.4
Estimation Comments Difference is SPID72 in tapentadol IR group minus SPID72 in placebo group.
7.Secondary Outcome
Title Total Pain Relief (TOTPAR) Over 12, 24, 48, and 72 Hours
Hide Description Participants rated pain relief rated on 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 of pain relief scores up to Hour 12, 24, 48, and 72 hours. Total score ranges from 0 (worst) to 48 (best) for TOTPAR12, 0 (worst) to 96 (best) for TOTPAR24, 0 (worst) to 192 (best) for TOTPAR48, and 0 (worst) to 288 (best) for TOTPAR72. A higher value of TOTPAR indicated greater pain relief.
Time Frame 12, 24, 48, and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values
Arm/Group Title Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Hide Arm/Group Description:
Each participant received matching placebo once every 4 to 6 hours for 3 days
Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Overall Number of Participants Analyzed 114 121 117
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
12 hours 7.8  (7.21) 15.0  (8.94) 15.1  (9.99)
24 hours 19.4  (16.91) 34.5  (19.04) 35.1  (19.50)
48 hours 53.8  (44.60) 88.4  (40.24) 87.6  (41.34)
72 hours 94.7  (76.12) 151.3  (64.14) 148.5  (65.29)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 12 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.15
Confidence Interval (2-Sided) 95%
5.0 to 9.3
Estimation Comments Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 12 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 7.13
Confidence Interval (2-Sided) 95%
4.9 to 9.3
Estimation Comments Difference is TOTPAR12 in tapentadol IR group minus TOTPAR12 in placebo group
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 24 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 15.21
Confidence Interval (2-Sided) 95%
10.6 to 19.8
Estimation Comments Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 24 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 15.54
Confidence Interval (2-Sided) 95%
10.9 to 20.2
Estimation Comments Difference is TOTPAR24 in tapentadol IR group minus TOTPAR24 in placebo group
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 48 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 34.76
Confidence Interval (2-Sided) 95%
24.3 to 45.3
Estimation Comments Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 48 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 33.60
Confidence Interval (2-Sided) 95%
23.0 to 44.2
Estimation Comments Difference is TOTPAR48 in tapentadol IR group minus TOTPAR48 in placebo group
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 72 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 56.59
Confidence Interval (2-Sided) 95%
39.4 to 73.8
Estimation Comments Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 72 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA including treatment group and center as factors and baseline pain intenstidy as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 53.48
Confidence Interval (2-Sided) 95%
36.2 to 70.8
Estimation Comments Difference is TOTPAR72 in tapentadol IR group minus TOTPAR72 in placebo group
8.Secondary Outcome
Title Sum of Pain Relief and Pain Intensity Differences (SPRID) Over 12, 24, 48, and 72 Hours
Hide Description Participants rated pain relief rated on 5-point categorical scale of 0-4 (0=none, 1=A little, 2=Some, 3=A lot, 4=Complete). Pain Intensity (PI) was assessed on an 11-point numerical rating scale from 0=no pain to 10=pain as bad as you can imagine. PID was the difference between baseline PI (prior to the first dose) and current PI at assessment. PRID is the sum of pain relief and PID at the same assessment time. SPRID was calculated as the time-weighted Sum of PRID scores over 12, 24, 48, and 72 hours. Total score ranges from -120 (worst) to 168 (best) for SPRID12, -240 (worst) to 336 (best) for SPRID24, -480 (worst) to 672 (best) for SPRID48, and -720 (worst) to 1008 (best) for SPRID72. A higher value of SPRID indicates greater pain relief.
Time Frame 12, 24, 48, and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication. Last-observation-carried-forward imputation method used for missing values.
Arm/Group Title Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Hide Arm/Group Description:
Each participant received matching placebo once every 4 to 6 hours for 3 days
Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Overall Number of Participants Analyzed 114 121 117
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
12 hours 13.6  (29.13) 35.4  (28.74) 39.7  (36.18)
24 hours 37.1  (65.27) 82.6  (61.99) 95.2  (74.14)
48 hours 119.1  (159.28) 220.2  (137.54) 242.1  (157.04)
72 hours 222.6  (265.92) 385.7  (220.15) 412.6  (244.92)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 12 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 23.66
Confidence Interval (2-Sided) 95%
16.4 to 30.9
Estimation Comments Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 12 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 26.24
Confidence Interval (2-Sided) 95%
18.9 to 33.6
Estimation Comments Difference is SPRID12 in the tapentadol IR group minus SPRID12 in the placebo group
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 24 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 49.93
Confidence Interval (2-Sided) 95%
34.4 to 65.4
Estimation Comments Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 24 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 58.58
Confidence Interval (2-Sided) 95%
43.0 to 74.2
Estimation Comments Difference is SPRID24 in the tapentadol IR group minus SPRID24 in the placebo group
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 48 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 111.12
Confidence Interval 95%
76.3 to 145.9
Estimation Comments Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 48 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 124.21
Confidence Interval (2-Sided) 95%
89.2 to 159.2
Estimation Comments Difference is SPRID48 in the tapentadol IR group minus SPRID48 in the placebo group
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments 72 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 178.91
Confidence Interval (2-Sided) 95%
122.4 to 235.4
Estimation Comments Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments 72 hours
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method ANCOVA
Comments ANCOVA with treatment group and center as factors and baseline pain intensity as covariate
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 192.05
Confidence Interval (2-Sided) 95%
135.2 to 248.9
Estimation Comments Difference is SPRID72 in the tapentadol IR group minus SPRID72 in the placebo group
9.Secondary Outcome
Title Patient Global Impression of Change (PGI-C) Score at 72 Hours
Hide Description The PGI-C is a 7-point scale that requires the patients to assess how much their illness has improved or worsened relative to a baseline state at the beginning of the intervention. The response options are: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. Higher scores indicate worsening.
Time Frame Baseline (Day 1) and 72 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) analysis set, which included all randomized participants with at least 1 dose of study medication.
Arm/Group Title Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Hide Arm/Group Description:
Each participant received matching placebo once every 4 to 6 hours for 3 days
Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
Overall Number of Participants Analyzed 114 121 117
Measure Type: Number
Unit of Measure: Percentage of participants
Very Much Improved 28.9 44.6 46.2
Much Improved 23.7 36.4 37.6
Minimally Improved 11.4 8.3 6.0
No Change 21.1 5.0 6.0
Minimally Worse 7.9 3.3 1.7
Much Worse 6.1 0.8 1.7
Very Much Worse 0.9 1.7 0.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 50 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo, Tapentadol IR 75 mg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Controlling for center
Time Frame Up to Day 30
Adverse Event Reporting Description For serious adverse events, events with onset up to 30 days after the last dose were included. For other adverse events, events with onset up to 48 hours after the last dose were included.
 
Arm/Group Title Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Hide Arm/Group Description Each participant received matching placebo once every 4 to 6 hours for 3 days Each participant received 50 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days Each participant received 75 mg of Tapentadol immediate release (IR) once every 4 to 6 hours for 3 days
All-Cause Mortality
Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)   2/121 (1.65%)   0/117 (0.00%) 
Injury, poisoning and procedural complications       
Procedural site reaction * 1  0/114 (0.00%)  1/121 (0.83%)  0/117 (0.00%) 
Nervous system disorders       
Essential tremor * 1  0/114 (0.00%)  1/121 (0.83%)  0/117 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Placebo Tapentadol IR 50 mg Tapentadol IR 75 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   22/114 (19.30%)   58/121 (47.93%)   74/117 (63.25%) 
Gastrointestinal disorders       
Constipation * 1  1/114 (0.88%)  7/121 (5.79%)  8/117 (6.84%) 
Nausea * 1  8/114 (7.02%)  44/121 (36.36%)  52/117 (44.44%) 
Vomiting * 1  4/114 (3.51%)  14/121 (11.57%)  26/117 (22.22%) 
General disorders       
Pyrexia * 1  11/114 (9.65%)  5/121 (4.13%)  8/117 (6.84%) 
Injury, poisoning and procedural complications       
Procedural dizziness * 1  3/114 (2.63%)  14/121 (11.57%)  22/117 (18.80%) 
Nervous system disorders       
Dizziness postural * 1  0/114 (0.00%)  6/121 (4.96%)  6/117 (5.13%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 15.1
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
Name/Title: Clinical Leader
Organization: Janssen Research & Development, L.L.C.
Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01516008     History of Changes
Other Study ID Numbers: CR100459
R331333PAI3030 ( Other Identifier: Janssen Research & Development, LLC )
First Submitted: January 19, 2012
First Posted: January 24, 2012
Results First Submitted: January 24, 2014
Results First Posted: April 28, 2014
Last Update Posted: April 28, 2014