Study of Diclofenac Capsules to Treat Dental Pain

Phase 2

Completed

• Conditions: Dental Pain
• Interventions: Drug: Diclofenac Test (lower dose); Drug: Diclofenac Test (upper dose); Drug: Celecoxib 400 mg; Drug: Placebo

• Registration Number: NCT00985439
• Lead Sponsor: Iroko Pharmaceuticals, LLC

Brief Summary

The purpose of this study is to determine whether Diclofenac Test Formulation Capsules are safe and effective for the treatment of dental pain.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-25
• Study First Submitted QC: 2009-09-25
• Study First Posted: 2009-09-28
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Results First Submitted: 2011-11-22
• Status Verified: 2012-03
• Results First Submitted QC: 2012-03-01
• Results First Posted: 2012-03-29
• Last Update Submitted: 2012-05-15
• Last Update Posted: 2012-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• Patient is male or female between 18 and 50 years of age
• For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
• Patient requires extraction of 2 or more third molars
• Patient must be willing to stay at the study site overnight

Exclusion Criteria

• Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
• Patient has a current disease or history of a disease that will impact the study or the patient's well-being
• Patient has used or intends to use any of the medications that are prohibited by the protocol
• Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
• Patient has taken another investigational drug within 30 days prior to Screening

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac Test (lower dose)	Diclofenac Test (lower dose)	One 18-mg Diclofenac Test Capsule and 1 placebo capsule
Diclofenac Test (upper dose)	Diclofenac Test (upper dose)	One 35-mg Diclofenac Test Capsule and 1 placebo capsule
Celecoxib 400 mg	Celecoxib 400 mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Total Patient Pain Relief Over 0 to 12 Hours.	12 hours.	Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-12 hours.; Values for TOTPAR are measured from 0 to 4 on the Pain Relief Scale 0 None Min; 1 A little; 2 Some; 3 A lot; 4 Complete Max; The TOTPAR is a weighted measure of the observations; the minimum possible value is 0 and the maximum possible value is 60.

Trial Locations

Locations (1)

Premier Research Group Limited; 🇺🇸 Austin, Texas, United States