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Study of Indomethacin Capsules to Treat Pain Following Bunionectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01543685
First received: February 28, 2012
Last updated: January 2, 2014
Last verified: January 2014
History of Changes
Results First Received: February 27, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Other Acute Postoperative Pain
Interventions: Drug: Indomethacin
Drug: Celecoxib
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Indomethacin 40 mg TID Indomethacin : 40 mg TID capsules
Indomethacin 40 mg BID Indomethacin : 40 mg BID capsules
Indomethacin 20 mg TID Indomethacin : 20 mg TID capsules
Celecoxib 200 mg Celecoxib : 200 mg capsules
Placebo Placebo : Capsules

Participant Flow:   Overall Study
    Indomethacin 40 mg TID   Indomethacin 40 mg BID   Indomethacin 20 mg TID   Celecoxib 200 mg   Placebo
STARTED   93   91   91   93   94 
COMPLETED   90   88   89   93   90 
NOT COMPLETED   3   3   2   0   4 
Lack of Efficacy                1                2                2                0                2 
Adverse Event                2                1                0                0                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Celecoxib 200 mg Celecoxib : 200 mg capsules
Indomethacin 20 mg TID Indomethacin : 20 mg TID capsules
Indomethacin 40 mg BID Indomethacin : 40 mg BID capsules
Indomethacin 40 mg TID Indomethacin : 40 mg TID capsules
Placebo Placebo : Capsules
Total Total of all reporting groups

Baseline Measures
   Celecoxib 200 mg   Indomethacin 20 mg TID   Indomethacin 40 mg BID   Indomethacin 40 mg TID   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 93   91   91   93   94   462 
Age 
[Units: Years]
Mean (Standard Deviation) 		 41.0  (12.3)   41.5  (13.4)   41.4  (12.4)   41.5  (11.4)   40.4  (13.3)   41.2  (12.5) 
Gender 
[Units: Participants]
 		           
Female   77   79   72   79   77   384 
Male   16   12   19   14   17   78 
Region of Enrollment 
[Units: Participants]
 		           
United States   93   91   91   93   94   462 


  Outcome Measures
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1.  Primary:   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)   [ Time Frame: 0 - 48 hours ]
  Show Outcome Measure 1

2.  Secondary:   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.   [ Time Frame: 0 - 4 hours ]
  Show Outcome Measure 2

3.  Secondary:   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.   [ Time Frame: 0 - 8 hours ]
  Show Outcome Measure 3

4.  Secondary:   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   [ Time Frame: 0 - 24 hours ]
  Show Outcome Measure 4

5.  Secondary:   Total Pain Relief (TOTPAR) Over 0 to 4 Hours (TOTPAR-4).   [ Time Frame: 0 - 4 hours ]
  Show Outcome Measure 5

6.  Secondary:   TOTPAR-8. Total Pain Relief (TOTPAR) Over 0 to 8 Hours   [ Time Frame: 0 - 8 hours ]
  Show Outcome Measure 6

7.  Secondary:   TOTPAR-24. Total Pain Relief (TOTPAR) Over 0 to 24 Hours   [ Time Frame: 0 - 24 hours ]
  Show Outcome Measure 7

8.  Secondary:   TOTPAR-48. Total Pain Relief (TOTPAR) Over 0 to 48 Hours   [ Time Frame: 0 - 48 hours ]
  Show Outcome Measure 8


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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
e-mail: dsolorio@iroko.com



Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01543685     History of Changes
Other Study ID Numbers: IND3-08-04b
Study First Received: February 28, 2012
Results First Received: February 27, 2013
Last Updated: January 2, 2014