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Study of Indomethacin Capsules to Treat Pain Following 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: NCT01543685
Recruitment Status : Completed
First Posted : March 5, 2012
Results First Posted : December 19, 2013
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Other Acute Postoperative Pain
Interventions Drug: Indomethacin
Drug: Celecoxib
Drug: Placebo
Enrollment 462
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Celecoxib 200 mg Placebo
Hide Arm/Group Description Indomethacin : 40 mg TID capsules Indomethacin : 40 mg BID capsules Indomethacin : 20 mg TID capsules Celecoxib : 200 mg capsules Placebo : Capsules
Period Title: Overall Study
Started 93 91 91 93 94
Completed 90 88 89 93 90
Not Completed 3 3 2 0 4
Reason Not Completed
Lack of Efficacy             1             2             2             0             2
Adverse Event             2             1             0             0             2
Arm/Group Title Celecoxib 200 mg Indomethacin 20 mg TID Indomethacin 40 mg BID Indomethacin 40 mg TID Placebo Total
Hide Arm/Group Description Celecoxib : 200 mg capsules Indomethacin : 20 mg TID capsules Indomethacin : 40 mg BID capsules Indomethacin : 40 mg TID capsules Placebo : Capsules Total of all reporting groups
Overall Number of Baseline Participants 93 91 91 93 94 462
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 93 participants 91 participants 91 participants 93 participants 94 participants 462 participants
41.0  (12.3) 41.5  (13.4) 41.4  (12.4) 41.5  (11.4) 40.4  (13.3) 41.2  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 93 participants 91 participants 91 participants 93 participants 94 participants 462 participants
Female
77
  82.8%
79
  86.8%
72
  79.1%
79
  84.9%
77
  81.9%
384
  83.1%
Male
16
  17.2%
12
  13.2%
19
  20.9%
14
  15.1%
17
  18.1%
78
  16.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 93 participants 91 participants 91 participants 93 participants 94 participants 462 participants
93 91 91 93 94 462
1.Primary Outcome
Title The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale From 0 to 48 Hours After Trial Entry (VASSPID-48)
Hide Description

The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".

The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.

Time Frame 0 - 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Celecoxib 200 mg Placebo
Hide Arm/Group Description:
Indomethacin : 40 mg TID capsules
Indomethacin : 40 mg BID capsules
Indomethacin : 20 mg TID capsules
Celecoxib : 200 mg capsules
Placebo : Capsules
Overall Number of Participants Analyzed 93 91 91 93 94
Mean (Standard Deviation)
Unit of Measure: mm*hour
508.2  (1125.6) 329.8  (903.3) 377.3  (1045.1) 280.5  (799.8) 69.4  (364.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg TID, Placebo
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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 441.8
Confidence Interval (2-Sided) 95%
187.1 to 696.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 129.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.046
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 260.2
Confidence Interval (2-Sided) 95%
4.1 to 516.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 130.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Indomethacin 20 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 312.7
Confidence Interval (2-Sided) 95%
56.6 to 568.9
Parameter Dispersion
Type: Standard Error of the mean
Value: 130.4
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.103
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 211.6
Confidence Interval (2-Sided) 95%
-43.1 to 466.2
Parameter Dispersion
Type: Standard Error of the mean
Value: 129.6
Estimation Comments [Not Specified]
2.Secondary Outcome
Title VASSPID-4. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 4 Hours After Trial Entry.
Hide Description

The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".

The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.

Time Frame 0 - 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Celecoxib 200 mg Placebo
Hide Arm/Group Description:
Indomethacin : 40 mg TID capsules
Indomethacin : 40 mg BID capsules
Indomethacin : 20 mg TID capsules
Celecoxib : 200 mg capsules
Placebo : Capsules
Overall Number of Participants Analyzed 93 91 91 93 94
Mean (Standard Deviation)
Unit of Measure: mm*hour
30.7  (74.9) 29.8  (70.8) 17.9  (57.1) 20.4  (54.6) 8.9  (38.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.013
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.014
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Indomethacin 20 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.211
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.098
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
3.Secondary Outcome
Title VASSPID-8. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 8 Hours After Trial Entry.
Hide Description

The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".

The VAS summed pain intensity difference (VASSPID) is calculated as the sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.

Time Frame 0 - 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Celecoxib 200 mg Placebo
Hide Arm/Group Description:
Indomethacin : 40 mg TID capsules
Indomethacin : 40 mg BID capsules
Indomethacin : 20 mg TID capsules
Celecoxib : 200 mg capsules
Placebo : Capsules
Overall Number of Participants Analyzed 93 91 91 93 94
Mean (Standard Deviation)
Unit of Measure: mm*hour
64.1  (144.6) 55.4  (132.4) 45.7  (122.7) 37.2  (97.4) 12.0  (49.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg TID, Placebo
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 t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Indomethacin 20 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.028
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
4.Secondary Outcome
Title VASSPID-24. The Time-Weighted Summed Pain Intensity Difference Measured Using the 100-mm Visual Analogue Scale (VASSPID) From 0 to 24 Hours After Trial Entry
Hide Description

The pain intensity is assessed using a visual analogue scale (VAS), which is a horizontal line 100 mm in length. Subjects mark the VAS with a single vertical line to indicate their current pain level, with 0 mm representing "No Pain" and 100 mm representing "Worst Possible Pain".

The VAS summed pain intensity difference (VASSPID) is calculated as a time-weighted sum of the pain intensity difference values at each follow-up time point (difference between the starting pain intensity and the pain intensity at the given assessment time) multiplied by the amount of time (in hours) since the prior assessment.

Time Frame 0 - 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Celecoxib 200 mg Placebo
Hide Arm/Group Description:
Indomethacin : 40 mg TID capsules
Indomethacin : 40 mg BID capsules
Indomethacin : 20 mg TID capsules
Celecoxib : 200 mg capsules
Placebo : Capsules
Overall Number of Participants Analyzed 93 91 91 93 94
Mean (Standard Deviation)
Unit of Measure: mm*hour
226.9  (500.9) 158.3  (405.2) 176.9  (469.6) 119.4  (329.6) 28.3  (132.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg TID, Placebo
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 t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Indomethacin 20 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
5.Secondary Outcome
Title Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).
Hide Description

Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.

The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 16 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.

Time Frame 0 - 4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Celecoxib 200 mg Placebo
Hide Arm/Group Description:
Indomethacin : 40 mg TID capsules
Indomethacin : 40 mg BID capsules
Indomethacin : 20 mg TID capsules
Celecoxib : 200 mg capsules
Placebo : Capsules
Overall Number of Participants Analyzed 93 91 91 93 94
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
2.5  (3.6) 2.1  (3.4) 1.7  (2.9) 1.8  (2.8) 1.2  (2.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.022
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Indomethacin 20 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.146
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.071
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
6.Secondary Outcome
Title TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours
Hide Description

Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.

The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 32 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.

Time Frame 0 - 8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Celecoxib 200 mg Placebo
Hide Arm/Group Description:
Indomethacin : 40 mg TID capsules
Indomethacin : 40 mg BID capsules
Indomethacin : 20 mg TID capsules
Celecoxib : 200 mg capsules
Placebo : Capsules
Overall Number of Participants Analyzed 93 91 91 93 94
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
4.5  (7.4) 3.4  (6.3) 3.4  (6.3) 3.0  (5.6) 1.5  (2.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg TID, Placebo
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 t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Indomethacin 20 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.010
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.016
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
7.Secondary Outcome
Title TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours
Hide Description

Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.

The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 96 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.

Time Frame 0 - 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Celecoxib 200 mg Placebo
Hide Arm/Group Description:
Indomethacin : 40 mg TID capsules
Indomethacin : 40 mg BID capsules
Indomethacin : 20 mg TID capsules
Celecoxib : 200 mg capsules
Placebo : Capsules
Overall Number of Participants Analyzed 93 91 91 93 94
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
13.4  (26.4) 8.9  (20.4) 10.0  (23.0) 7.7  (18.1) 2.6  (8.8)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg TID, Placebo
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 t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.008
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Indomethacin 20 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.017
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
8.Secondary Outcome
Title TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours
Hide Description

Pain relief was assessed using a 5-point categorical scale at all assessment time points after time 0. Subjects were asked “How much relief have you had since your starting pain?” with response choices of none = 0, a little = 1, some = 2, a lot = 3, and complete = 4.

The Total Pain Relief (TOTPAR) score for a given time interval is calculated as the sum of the pain relief scores at each follow-up time point (as recorded on the categorical pain relief scale) over that interval multiplied by the amount of time (in hours) since the prior assessment. In this way individual scores covering a longer time period were given more weight. The minimum theoretical score is 0 units, which represent no relief from pain (score of 0 on categorical scale) at all time points after time 0. The maximum theoretical score is 192 units, which represents complete relief from pain (score of 4 on a categorical scale) at all time points after time 0.

Time Frame 0 - 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat Population
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Celecoxib 200 mg Placebo
Hide Arm/Group Description:
Indomethacin : 40 mg TID capsules
Indomethacin : 40 mg BID capsules
Indomethacin : 20 mg TID capsules
Celecoxib : 200 mg capsules
Placebo : Capsules
Overall Number of Participants Analyzed 93 91 91 93 94
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
29.3  (59.8) 17.8  (45.6) 19.6  (49.3) 16.4  (43.2) 5.2  (22.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg TID, Placebo
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 t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg BID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.020
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Indomethacin 20 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Celecoxib 200 mg, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.029
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Celecoxib 200 mg Indomethacin 20 mg TID Indomethacin 40 mg BID Indomethacin 40 mg TID Placebo
Hide Arm/Group Description Celecoxib : 200 mg capsules Indomethacin : 20 mg TID capsules Indomethacin : 40 mg BID capsules Indomethacin : 40 mg TID capsules Placebo : Capsules
All-Cause Mortality
Celecoxib 200 mg Indomethacin 20 mg TID Indomethacin 40 mg BID Indomethacin 40 mg TID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib 200 mg Indomethacin 20 mg TID Indomethacin 40 mg BID Indomethacin 40 mg TID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/93 (0.00%)   0/91 (0.00%)   1/91 (1.10%)   0/93 (0.00%)   0/94 (0.00%) 
Vascular disorders           
Deep vein thrombosis  0/93 (0.00%)  0/91 (0.00%)  1/91 (1.10%)  0/93 (0.00%)  0/94 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Celecoxib 200 mg Indomethacin 20 mg TID Indomethacin 40 mg BID Indomethacin 40 mg TID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   68/93 (73.12%)   69/91 (75.82%)   74/91 (81.32%)   66/93 (70.97%)   71/94 (75.53%) 
Gastrointestinal disorders           
Nausea  30/93 (32.26%)  29/91 (31.87%)  24/91 (26.37%)  30/93 (32.26%)  34/94 (36.17%) 
Vomiting  3/93 (3.23%)  10/91 (10.99%)  7/91 (7.69%)  5/93 (5.38%)  13/94 (13.83%) 
Injury, poisoning and procedural complications           
Post procedural edema  25/93 (26.88%)  23/91 (25.27%)  22/91 (24.18%)  24/93 (25.81%)  31/94 (32.98%) 
Post procedural hemorrhage  8/93 (8.60%)  6/91 (6.59%)  13/91 (14.29%)  5/93 (5.38%)  6/94 (6.38%) 
Nervous system disorders           
Dizziness  7/93 (7.53%)  6/91 (6.59%)  14/91 (15.38%)  12/93 (12.90%)  16/94 (17.02%) 
Headache  5/93 (5.38%)  11/91 (12.09%)  13/91 (14.29%)  12/93 (12.90%)  7/94 (7.45%) 
Presyncope  2/93 (2.15%)  1/91 (1.10%)  5/91 (5.49%)  1/93 (1.08%)  2/94 (2.13%) 
Skin and subcutaneous tissue disorders           
Erythema  1/93 (1.08%)  2/91 (2.20%)  2/91 (2.20%)  2/93 (2.15%)  6/94 (6.38%) 
Pruritus  4/93 (4.30%)  5/91 (5.49%)  1/91 (1.10%)  3/93 (3.23%)  0/94 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
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Name/Title: Daniel Solorio
Organization: Iroko Pharmaceuticals, LLC
Phone: 267-546-3150
EMail: dsolorio@iroko.com
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Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01543685     History of Changes
Other Study ID Numbers: IND3-08-04b
First Submitted: February 28, 2012
First Posted: March 5, 2012
Results First Submitted: February 27, 2013
Results First Posted: December 19, 2013
Last Update Posted: February 4, 2014