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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 
Overall Participants Analyzed 
[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



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