Study of Diclofenac Capsules to Treat Dental Pain

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

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

Study Overview

• Status: Completed
• Conditions: Dental Pain
• Intervention / Treatment: Drug: Diclofenac Test (lower dose); Drug: Diclofenac Test (upper dose); Drug: Celecoxib 400 mg; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 202
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Texas
    • Austin, Texas, United States, 78705
      • Premier Research Group Limited

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; Capsules 2 Single-dose
Experimental: Diclofenac Test (lower dose); One 18-mg Diclofenac Test Capsule and 1 placebo capsule	Drug: Diclofenac Test (lower dose); 18-mg Single dose
Experimental: Diclofenac Test (upper dose); One 35-mg Diclofenac Test Capsule and 1 placebo capsule	Drug: Diclofenac Test (upper dose); 35-mg Single dose
Active Comparator: Celecoxib 400 mg	Drug: Celecoxib 400 mg; Capsules 2 x 200 mg Single-dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Iroko Pharmaceuticals, LLC

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): December 1, 2009

Study Registration Dates

• First Submitted: September 25, 2009
• First Submitted That Met QC Criteria: September 25, 2009
• First Posted (Estimate): September 28, 2009

Study Record Updates

• Last Update Posted (Estimate): May 22, 2012
• Last Update Submitted That Met QC Criteria: May 15, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Facial Pain; Toothache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Cyclooxygenase 2 Inhibitors; Celecoxib; Diclofenac
• Other Study ID Numbers: DIC2-08-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No