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Study of Diclofenac Capsules to Treat Dental Pain

Information source: Iroko Pharmaceuticals, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Dental Pain

Intervention: Diclofenac Test (lower dose) (Drug); Diclofenac Test (upper dose) (Drug); Celecoxib 400 mg (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Iroko Pharmaceuticals, LLC

Summary

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

Clinical Details

Official title: A Phase 2, Randomized, Double-Blind, Single-Dose, Parallel-Group, Active- and Placebo-Controlled Study of Diclofenac [Test] Capsules for the Treatment of Pain After Surgical Removal of Impacted Third Molars

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

Primary outcome: Total Patient Pain Relief Over 0 to 12 Hours.

Eligibility

Minimum age: 18 Years. Maximum age: 50 Years. Gender(s): Both.

Criteria:

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

Locations and Contacts

Premier Research Group Limited, Austin, Texas 78705, United States
Additional Information

Starting date: September 2009
Last updated: May 15, 2012

Page last updated: August 23, 2015

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