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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: NCT01626118
Recruitment Status : Completed
First Posted : June 22, 2012
Results First Posted : March 17, 2014
Last Update Posted : March 17, 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: Placebo
Enrollment 373
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo
Hide Arm/Group Description Indomethacin Nanoformulation Capsules 40 mg TID Indomethacin Nanoformulation Capsules 40 mg BID Indomethacin Nanoformulation Capsules 20 mg TID Placebo Group
Period Title: Overall Study
Started 94 93 92 94
Completed 92 91 90 91
Not Completed 2 2 2 3
Reason Not Completed
Lack of Efficacy             1             0             1             3
Lost to Follow-up             1             0             0             0
Adverse Event             0             1             1             0
Investigator Decision             0             1             0             0
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo Total
Hide Arm/Group Description Indomethacin Nanoformulation Capsules 40 mg TID Indomethacin Nanoformulation Capsules 40 mg BID Indomethacin Nanoformulation Capsules 20 mg TID Placebo Group Total of all reporting groups
Overall Number of Baseline Participants 94 93 92 94 373
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 94 participants 93 participants 92 participants 94 participants 373 participants
40.2  (12.27) 38.9  (12.5) 41.3  (12.57) 40.7  (11.32) 40.3  (12.16)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 92 participants 94 participants 373 participants
Female
80
  85.1%
77
  82.8%
77
  83.7%
83
  88.3%
317
  85.0%
Male
14
  14.9%
16
  17.2%
15
  16.3%
11
  11.7%
56
  15.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 92 participants 94 participants 373 participants
Hispanic or Latino
15
  16.0%
26
  28.0%
12
  13.0%
20
  21.3%
73
  19.6%
Not Hispanic or Latino
79
  84.0%
67
  72.0%
80
  87.0%
74
  78.7%
300
  80.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 94 participants 93 participants 92 participants 94 participants 373 participants
American Indian or Alaska Native 2 2 0 1 5
Asian 2 2 2 2 8
Native Hawaiian or Other Pacific Islander 0 1 2 0 3
Black or African American 15 25 21 19 80
White or Caucasian 77 66 69 70 282
Other 0 0 1 2 3
[1]
Measure Description: Subjects were allowed to select more than one race; therefore, some subjects are counted multiple times.
Weight (kg)   [1] 
Mean (Standard Deviation)
Unit of measure:  KG
Number Analyzed 94 participants 93 participants 92 participants 94 participants 373 participants
73.81  (14.686) 72.77  (15.761) 74.99  (17.821) 71.22  (14.607) 73.19  (15.758)
[1]
Measure Description: Weight measured in kilogram
Height (cm)   [1] 
Mean (Standard Deviation)
Unit of measure:  CM
Number Analyzed 94 participants 93 participants 92 participants 94 participants 373 participants
166.28  (8.059) 165.65  (8.994) 166.52  (9.761) 165.61  (7.646) 166.01  (8.621)
[1]
Measure Description: Height measured in centimeters
BMI (kg/m^2)   [1] 
Mean (Standard Deviation)
Unit of measure:  KG/M^2
Number Analyzed 94 participants 93 participants 92 participants 94 participants 373 participants
26.5  (4.49) 26.3  (4.34) 26.7  (4.73) 25.8  (4.57) 26.3  (4.52)
[1]
Measure Description: Body mass index measured in kilograms per meter squared.
Baseline pain intensity, mm   [1] 
Mean (Standard Deviation)
Unit of measure:  Mm
Number Analyzed 94 participants 93 participants 92 participants 94 participants 373 participants
71.0  (16.33) 71.2  (16.11) 72.3  (15.90) 73.9  (16.6) 72.1  (16.21)
[1]
Measure 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".
Surgery duration, min   [1] 
Mean (Standard Deviation)
Unit of measure:  Minutes
Number Analyzed 94 participants 93 participants 92 participants 94 participants 373 participants
27.7  (7.45) 27.6  (7.95) 28.5  (8.63) 27.2  (6.59) 27.7  (7.67)
[1]
Measure Description: Surgery duration, minutes
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". Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40, and 48 hours.

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. All subjects who received at least 1 dose of trial drug.
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo
Hide Arm/Group Description:
Indomethacin Nanoformulation Capsules 40 mg TID
Indomethacin Nanoformulation Capsules 40 mg BID
Indomethacin Nanoformulation Capsules 20 mg TID
Placebo Group
Overall Number of Participants Analyzed 94 93 92 94
Mean (Standard Deviation)
Unit of Measure: mm*hour
598.670  (1173.7863) 623.162  (1182.0912) 342.779  (858.6326) 280.517  (817.6026)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg TID, Placebo
Comments The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.034
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 317.612
Confidence Interval (2-Sided) 95%
23.297 to 611.926
Parameter Dispersion
Type: Standard Error of the mean
Value: 149.6694
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg BID, Placebo
Comments The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.023
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 342.132
Confidence Interval (2-Sided) 95%
47.090 to 637.175
Parameter Dispersion
Type: Standard Error of the mean
Value: 150.0397
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Indomethacin 20 mg TID, Placebo
Comments The p value was obtained from an analysis of covariance (ANCOVA) model that included treatment effect as the factor and baseline pain intensity as the covariate. This was the primary analysis of the primary efficacy parameter.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.680
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 61.972
Confidence Interval (2-Sided) 95%
-233.527 to 357.471
Parameter Dispersion
Type: Standard Error of the mean
Value: 150.2717
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg TID, Placebo
Comments The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than “imputing” a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 503.008
Confidence Interval (2-Sided) 95%
301.930 to 704.086
Parameter Dispersion
Type: Standard Error of the mean
Value: 102.3149
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg BID, Placebo
Comments The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than “imputing” a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 511.357
Confidence Interval (2-Sided) 95%
309.749 to 712.965
Parameter Dispersion
Type: Standard Error of the mean
Value: 102.5851
Estimation Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Indomethacin 20 mg TID, Placebo
Comments The p value was obtained from a mixed-model repeated-measure (MMRM) model that used all available data from all subjects to derive an estimate of pain intensity scores for subjects following study withdrawal, rather than “imputing” a score for individual subjects. The MMRM analysis was a sensitivity analysis of the primary efficacy parameter.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 341.232
Confidence Interval (2-Sided) 95%
139.249 to 543.215
Parameter Dispersion
Type: Standard Error of the mean
Value: 102.7761
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". Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, and 4 hours.

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. All subjects who received at least 1 dose of trial drug.
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo
Hide Arm/Group Description:
Indomethacin Nanoformulation Capsules 40 mg TID
Indomethacin Nanoformulation Capsules 40 mg BID
Indomethacin Nanoformulation Capsules 20 mg TID
Placebo Group
Overall Number of Participants Analyzed 94 93 92 94
Mean (Standard Deviation)
Unit of Measure: mm*hour
31.5  (74.4) 35.3  (79.6) 24.8  (54.6) 18.4  (62.1)
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 0.191
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 0.108
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 0.461
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". Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, and 8 hours.

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. All subjects who received at least 1 dose of trial drug.
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo
Hide Arm/Group Description:
Indomethacin Nanoformulation Capsules 40 mg TID
Indomethacin Nanoformulation Capsules 40 mg BID
Indomethacin Nanoformulation Capsules 20 mg TID
Placebo Group
Overall Number of Participants Analyzed 94 93 92 94
Mean (Standard Deviation)
Unit of Measure: mm*hour
69.7  (151.7) 75.5  (152.5) 47.6  (109.9) 35.8  (107.9)
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 0.079
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 0.041
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 0.458
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". Pain intensity is assessed at baseline (time “0”) and at the following time points after time 0: 15, 30, and 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, and 24 hours.

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. All subjects who received at least 1 dose of trial drug.
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo
Hide Arm/Group Description:
Indomethacin Nanoformulation Capsules 40 mg TID
Indomethacin Nanoformulation Capsules 40 mg BID
Indomethacin Nanoformulation Capsules 20 mg TID
Placebo Group
Overall Number of Participants Analyzed 94 93 92 94
Mean (Standard Deviation)
Unit of Measure: mm*hour
268.4  (526.9) 265.2  (516.2) 156.8  (384.0) 115.5  (346.5)
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 0.020
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 0.021
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 0.441
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 with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3 & 4 hours.

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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 16 units, which represents complete pain relief (4 on scale) at all points after 0.

Time Frame 0-4 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo
Hide Arm/Group Description:
Indomethacin Nanoformulation Capsules 40 mg TID
Indomethacin Nanoformulation Capsules 40 mg BID
Indomethacin Nanoformulation Capsules 20 mg TID
Placebo Group
Overall Number of Participants Analyzed 94 93 92 94
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
2.6  (3.8) 2.8  (3.8) 2.0  (2.9) 1.9  (3.1)
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 0.141
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 0.071
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 0.716
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 with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7 & 8 hours.

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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 32 units, which represents complete pain relief (4 on scale) at all points after 0.

Time Frame 0-8 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo
Hide Arm/Group Description:
Indomethacin Nanoformulation Capsules 40 mg TID
Indomethacin Nanoformulation Capsules 40 mg BID
Indomethacin Nanoformulation Capsules 20 mg TID
Placebo Group
Overall Number of Participants Analyzed 94 93 92 94
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
5.0  (8.0) 5.4  (8.1) 3.5  (5.9) 3.0  (5.8)
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 0.049
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 0.593
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 with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, & 24 hours.

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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 96 units, which represents complete pain relief (4 on scale) at all points after 0.

Time Frame 0-24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo
Hide Arm/Group Description:
Indomethacin Nanoformulation Capsules 40 mg TID
Indomethacin Nanoformulation Capsules 40 mg BID
Indomethacin Nanoformulation Capsules 20 mg TID
Placebo Group
Overall Number of Participants Analyzed 94 93 92 94
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
16.2  (29.1) 16.8  (28.0) 10.1  (21.8) 7.8  (19.1)
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 0.021
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 0.012
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 0.447
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 with a 5-point categorical scale at all assessment timepoints 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. Pain relief is assessed at the following points after time 0: 15, 30 & 45 minutes and 1, 1.5, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 32, 40 & 48 hours.

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. Thus, individual scores covering a longer period were given more weight. The minimum theoretical score is 0 units, which represents no pain relief (0 on scale) at all points after time 0. The maximum theoretical score is 192 units, which represents complete pain relief (4 on scale) at all points after 0.

Time Frame 0-48 hours
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Hide Analysis Population Description
Intent-to-Treat Population. All subjects who received at least 1 dose of trial drug.
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo
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Indomethacin Nanoformulation Capsules 40 mg TID
Indomethacin Nanoformulation Capsules 40 mg BID
Indomethacin Nanoformulation Capsules 20 mg TID
Placebo Group
Overall Number of Participants Analyzed 94 93 92 94
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
34.7  (65.1) 37.0  (64.5) 21.2  (49.3) 17.3  (45.6)
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Statistical Analysis Overview Comparison Group Selection Indomethacin 40 mg TID, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
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Statistical Test of Hypothesis P-Value 0.036
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Method t-test, 2 sided
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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 0.017
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
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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 0.577
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo
Hide Arm/Group Description Indomethacin Nanoformulation Capsules 40 mg TID Indomethacin Nanoformulation Capsules 40 mg BID Indomethacin Nanoformulation Capsules 20 mg TID Placebo Group
All-Cause Mortality
Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
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Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/94 (0.00%)   0/93 (0.00%)   0/92 (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%
Indomethacin 40 mg TID Indomethacin 40 mg BID Indomethacin 20 mg TID Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   65/94 (69.15%)   74/93 (79.57%)   68/92 (73.91%)   71/94 (75.53%) 
Gastrointestinal disorders         
Nausea  32/94 (34.04%)  36/93 (38.71%)  34/92 (36.96%)  33/94 (35.11%) 
Vomiting  9/94 (9.57%)  12/93 (12.90%)  11/92 (11.96%)  8/94 (8.51%) 
Constipation  3/94 (3.19%)  7/93 (7.53%)  8/92 (8.70%)  5/94 (5.32%) 
Injury, poisoning and procedural complications         
Postprocedural edema  20/94 (21.28%)  18/93 (19.35%)  25/92 (27.17%)  29/94 (30.85%) 
Post procedural haemorrhage  4/94 (4.26%)  7/93 (7.53%)  3/92 (3.26%)  5/94 (5.32%) 
Nervous system disorders         
Dizziness  16/94 (17.02%)  12/93 (12.90%)  12/92 (13.04%)  16/94 (17.02%) 
Headache  17/94 (18.09%)  12/93 (12.90%)  9/92 (9.78%)  14/94 (14.89%) 
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Term from vocabulary, MedDRA 14.0
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
Name/Title: Daniel Solorio
Organization: Iroko Pharmaceuticals, LLC
Phone: 267-546-3150
Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01626118     History of Changes
Other Study ID Numbers: IND3-10-06
First Submitted: June 20, 2012
First Posted: June 22, 2012
Results First Submitted: December 11, 2013
Results First Posted: March 17, 2014
Last Update Posted: March 17, 2014