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Phase 2 Study of Indomethacin Capsules to Treat Dental Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00964431
First received: August 24, 2009
Last updated: May 15, 2012
Last verified: March 2012
History of Changes
Results First Received: November 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dental Pain
Interventions: Drug: Celecoxib 400 mg
Drug: Placebo
Drug: Indomethacin Test (lower dose)
Drug: Indomethacin Test (upper dose)

  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 Test (Lower Dose) No text entered.
Indomethacin Test (Upper Dose) Single dose
Celecoxib 400 mg No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Indomethacin Test (Lower Dose)     Indomethacin Test (Upper Dose)     Celecoxib 400 mg     Placebo  
STARTED     50     51     51     51  
COMPLETED     50     51     51     51  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Indomethacin Test (Lower Dose) No text entered.
Indomethacin Test (Upper Dose) Single dose
Celecoxib 400 mg No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Indomethacin Test (Lower Dose)     Indomethacin Test (Upper Dose)     Celecoxib 400 mg     Placebo     Total  
Number of Participants  
[units: participants]
 		  50     51     51     51     203  
Age  
[units: participants]
 		         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     50     51     51     51     203  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  22.0  ± 3.32     22.2  ± 3.81     22.1  ± 3.46     22.1  ± 2.97     22.1  ± 3.38  
Gender  
[units: participants]
 		         
Female     32     31     34     35     132  
Male     18     20     17     16     71  
Region of Enrollment  
[units: participants]
 		         
United States     50     51     51     51     203  



  Outcome Measures

1.  Primary:   Total Patient Pain Relief Over 0 to 8 Hours.   [ Time Frame: 8 hours ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Steven Jensen
Organization: Iroko Pharmaceuticals, LLC
phone: 267-546-3003
e-mail: sjensen@iroko.com


No publications provided


Responsible Party: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00964431     History of Changes
Other Study ID Numbers: IND2-08-03
Study First Received: August 24, 2009
Results First Received: November 22, 2011
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration