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Study of Diclofenac Capsules to Treat Pain Following Bunionectomy

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ClinicalTrials.gov Identifier: NCT01462435
Recruitment Status : Completed
First Posted : October 31, 2011
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: Diclofenac Test (lower dose)
Drug: Diclofenac Test (upper dose)
Drug: Celecoxib
Drug: Placebo
Enrollment 428
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo
Hide Arm/Group Description Celecoxib : 200 mg Capsules Diclofenac Test (lower dose) : Capsules Diclofenac Test (upper dose) : Capsules Placebo : Capsules
Period Title: Overall Study
Started 106 109 107 106
Completed 105 109 106 101
Not Completed 1 0 1 5
Reason Not Completed
Lack of Efficacy             1             0             0             3
Physician Decision             0             0             1             0
Withdrawal by Subject             0             0             0             1
Lost to Follow-up             0             0             0             1
Arm/Group Title Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo Total
Hide Arm/Group Description Celecoxib : 200 mg Capsules Diclofenac Test (lower dose) : Capsules Diclofenac Test (upper dose) : Capsules Placebo : Capsules Total of all reporting groups
Overall Number of Baseline Participants 106 109 107 106 428
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 109 participants 107 participants 106 participants 428 participants
40.3  (11.9) 39.4  (11.7) 39.3  (11.8) 39.9  (12.6) 39.7  (12.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 109 participants 107 participants 106 participants 428 participants
Female
96
  90.6%
94
  86.2%
89
  83.2%
92
  86.8%
371
  86.7%
Male
10
   9.4%
15
  13.8%
18
  16.8%
14
  13.2%
57
  13.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 106 participants 109 participants 107 participants 106 participants 428 participants
106 109 107 106 428
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), ANCOVA Model.
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 Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo
Hide Arm/Group Description:
Celecoxib : 200 mg Capsules
Diclofenac Test (lower dose) : Capsules
Diclofenac Test (upper dose) : Capsules
Placebo : Capsules
Overall Number of Participants Analyzed 106 109 107 106
Mean (Standard Deviation)
Unit of Measure: mm*hour
390.468  (925.1) 392.954  (937.0) 524.315  (1146.1) 76.887  (340.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac Test (Upper Dose), 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 446.946
Confidence Interval (2-Sided) 95%
206.567 to 687.324
Parameter Dispersion
Type: Standard Error of the mean
Value: 122.2935
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Diclofenac Test (Lower Dose), 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 ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 316.145
Confidence Interval (2-Sided) 95%
77.136 to 555.155
Parameter Dispersion
Type: Standard Error of the mean
Value: 121.5971
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.011
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in Least Squares Mean
Estimated Value 313.119
Confidence Interval (2-Sided) 95%
72.202 to 554.037
Parameter Dispersion
Type: Standard Error of the mean
Value: 122.5676
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
[Not Specified]
Arm/Group Title Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo
Hide Arm/Group Description:
Celecoxib : 200 mg Capsules
Diclofenac Test (lower dose) : Capsules
Diclofenac Test (upper dose) : Capsules
Placebo : Capsules
Overall Number of Participants Analyzed 106 109 107 106
Mean (Standard Deviation)
Unit of Measure: mm*hour
25.109  (62.9) 27.450  (64.9) 31.568  (68.6) 14.406  (53.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac Test (Upper Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.043
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 Diclofenac Test (Lower Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.109
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 Celecoxib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.183
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
[Not Specified]
Arm/Group Title Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo
Hide Arm/Group Description:
Celecoxib : 200 mg Capsules
Diclofenac Test (lower dose) : Capsules
Diclofenac Test (upper dose) : Capsules
Placebo : Capsules
Overall Number of Participants Analyzed 106 109 107 106
Mean (Standard Deviation)
Unit of Measure: mm*hour
51.675  (122.4) 56.404  (132.6) 64.689  (138.5) 23.151  (84.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac Test (Upper Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
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 Diclofenac Test (Lower Dose), 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]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.050
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 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 - 24 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo
Hide Arm/Group Description:
Celecoxib : 200 mg Capsules
Diclofenac Test (lower dose) : Capsules
Diclofenac Test (upper dose) : Capsules
Placebo : Capsules
Overall Number of Participants Analyzed 106 109 107 106
Mean (Standard Deviation)
Unit of Measure: mm*hour
170.845  (393.0) 177.101  (418.3) 230.708  (499.9) 48.811  (186.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac Test (Upper Dose), 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 Diclofenac Test (Lower Dose), 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 Celecoxib, 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]
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
[Not Specified]
Arm/Group Title Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo
Hide Arm/Group Description:
Celecoxib : 200 mg Capsules
Diclofenac Test (lower dose) : Capsules
Diclofenac Test (upper dose) : Capsules
Placebo : Capsules
Overall Number of Participants Analyzed 106 109 107 106
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
2.226  (3.5) 2.112  (3.5) 2.530  (3.6) 1.387  (2.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac Test (Upper Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.009
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 Diclofenac Test (Lower Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.091
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 Celecoxib, Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.053
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
[Not Specified]
Arm/Group Title Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo
Hide Arm/Group Description:
Celecoxib : 200 mg Capsules
Diclofenac Test (lower dose) : Capsules
Diclofenac Test (upper dose) : Capsules
Placebo : Capsules
Overall Number of Participants Analyzed 106 109 107 106
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
3.840  (6.8) 3.690  (6.8) 4.652  (7.5) 1.943  (4.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac Test (Upper Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
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 Diclofenac Test (Lower Dose), Placebo
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.026
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 Celecoxib, 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]
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
[Not Specified]
Arm/Group Title Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo
Hide Arm/Group Description:
Celecoxib : 200 mg Capsules
Diclofenac Test (lower dose) : Capsules
Diclofenac Test (upper dose) : Capsules
Placebo : Capsules
Overall Number of Participants Analyzed 106 109 107 106
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
10.670  (22.2595) 10.186  (21.3384) 13.325  (25.9326) 3.566  (10.8804)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac Test (Upper Dose), 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 Diclofenac Test (Lower Dose), 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 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, 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]
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
[Not Specified]
Arm/Group Title Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo
Hide Arm/Group Description:
Celecoxib : 200 mg Capsules
Diclofenac Test (lower dose) : Capsules
Diclofenac Test (upper dose) : Capsules
Placebo : Capsules
Overall Number of Participants Analyzed 106 109 107 106
Mean (Standard Deviation)
Unit of Measure: units on a scale*hour
22.972  (51.1) 21.635  (48.) 28.054  (58.1) 4.925  (19.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Diclofenac Test (Upper Dose), 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 Diclofenac Test (Lower Dose), 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 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Celecoxib, 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]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo
Hide Arm/Group Description Celecoxib : 200 mg Capsules Diclofenac Test (lower dose) : Capsules Diclofenac Test (upper dose) : Capsules Placebo : Capsules
All-Cause Mortality
Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/106 (0.94%)      0/109 (0.00%)      0/107 (0.00%)      0/106 (0.00%)    
Vascular disorders         
Deep vein thrombosis  1/106 (0.94%)  1 0/109 (0.00%)  0 0/107 (0.00%)  0 0/106 (0.00%)  0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Celecoxib Diclofenac Test (Lower Dose) Diclofenac Test (Upper Dose) Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   86/106 (81.13%)      84/109 (77.06%)      77/107 (71.96%)      63/106 (59.43%)    
Gastrointestinal disorders         
Nausea  29/106 (27.36%)  34/109 (31.19%)  25/107 (23.36%)  39/106 (36.79%) 
Vomiting  15/106 (14.15%)  13/109 (11.93%)  7/107 (6.54%)  13/106 (12.26%) 
Constipation  9/106 (8.49%)  12/109 (11.01%)  6/107 (5.61%)  4/106 (3.77%) 
Injury, poisoning and procedural complications         
Postprocedural edema  35/106 (33.02%)  36/109 (33.03%)  35/107 (32.71%)  34/106 (32.08%) 
Postprocedural hematoma  8/106 (7.55%)  12/109 (11.01%)  4/107 (3.74%)  11/106 (10.38%) 
Nervous system disorders         
Headache  11/106 (10.38%)  17/109 (15.60%)  11/107 (10.28%)  16/106 (15.09%) 
Dizziness  11/106 (10.38%)  17/109 (15.60%)  5/107 (4.67%)  17/106 (16.04%) 
Paraesthesia  8/106 (7.55%)  2/109 (1.83%)  2/107 (1.87%)  3/106 (2.83%) 
Skin and subcutaneous tissue disorders         
Pruritus  4/106 (3.77%)  4/109 (3.67%)  6/107 (5.61%)  4/106 (3.77%) 
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
Layout table for Results Point of Contact information
Name/Title: Daniel Solorio
Organization: Iroko Pharmaceuticals, LLC
Phone: 267-546-3150
EMail: dsolorio@iroko.com
Layout table for additonal information
Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01462435     History of Changes
Other Study ID Numbers: DIC3-08-04
First Submitted: October 26, 2011
First Posted: October 31, 2011
Results First Submitted: February 20, 2013
Results First Posted: December 19, 2013
Last Update Posted: February 4, 2014