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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00985439
Other study ID # DIC2-08-03
Secondary ID
Status Completed
Phase Phase 2
First received September 25, 2009
Last updated May 15, 2012
Start date September 2009
Est. completion date December 2009

Study information

Verified date March 2012
Source Iroko Pharmaceuticals, LLC
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 202
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 50 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Diclofenac Test (lower dose)
18-mg Single dose
Diclofenac Test (upper dose)
35-mg Single dose
Celecoxib 400 mg
Capsules 2 x 200 mg Single-dose
Placebo
Capsules 2 Single-dose

Locations

Country Name City State
United States Premier Research Group Limited Austin Texas

Sponsors (1)

Lead Sponsor Collaborator
Iroko Pharmaceuticals, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Patient Pain Relief Over 0 to 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.
12 hours. No
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