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Study of Diclofenac Capsules to Treat Dental Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Iroko Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00985439
First received: September 25, 2009
Last updated: May 15, 2012
Last verified: March 2012
Results First Received: November 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Dental Pain
Interventions: Drug: Diclofenac Test (lower dose)
Drug: Diclofenac Test (upper dose)
Drug: Celecoxib 400 mg
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
No text entered.

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
Diclofenac Test (Lower Dose) No text entered.
Diclofenac Test (Upper Dose) No text entered.
Celecoxib 400 mg No text entered.
Placebo No text entered.

Participant Flow:   Overall Study
    Diclofenac Test (Lower Dose)     Diclofenac Test (Upper Dose)     Celecoxib 400 mg     Placebo  
STARTED     49     51     51     51  
COMPLETED     49     51     50     51  
NOT COMPLETED     0     0     1     0  
Adverse Event                 0                 0                 1                 0  



  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.
No text entered.

Reporting Groups
  Description
Diclofenac Test (Lower Dose) No text entered.
Diclofenac Test (Upper Dose) No text entered.
Celecoxib 400 mg No text entered.
Placebo No text entered.
Total Total of all reporting groups

Baseline Measures
    Diclofenac Test (Lower Dose)     Diclofenac Test (Upper Dose)     Celecoxib 400 mg     Placebo     Total  
Number of Participants  
[units: participants]
  49     51     51     51     202  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     49     51     51     51     202  
>=65 years     0     0     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  22.1  ± 5.10     22.3  ± 4.58     22.7  ± 3.30     22.6  ± 4.22     22.4  ± 4.32  
Gender  
[units: participants]
         
Female     27     30     34     25     116  
Male     22     21     17     26     86  
Region of Enrollment  
[units: participants]
         
United States     49     51     51     51     202  



  Outcome Measures

1.  Primary:   Total Patient Pain Relief Over 0 to 12 Hours.   [ Time Frame: 12 hours. ]


  Serious Adverse Events


  Other Adverse Events


  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: 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: NCT00985439     History of Changes
Other Study ID Numbers: DIC2-08-03
Study First Received: September 25, 2009
Results First Received: November 22, 2011
Last Updated: May 15, 2012
Health Authority: United States: Food and Drug Administration