Study of Diclofenac Capsules to Treat Dental Pain

NCT00985439 | Completed Phase 2 Results

• 1 other identifier: DIC2-08-03
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Pain

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (4)

Diclofenac Test (lower dose)

EXPERIMENTAL

One 18-mg Diclofenac Test Capsule and 1 placebo capsule

Drug: Diclofenac Test (lower dose)

Diclofenac Test (upper dose)

EXPERIMENTAL

One 35-mg Diclofenac Test Capsule and 1 placebo capsule

Drug: Diclofenac Test (upper dose)

Celecoxib 400 mg

ACTIVE COMPARATOR

Drug: Celecoxib 400 mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Diclofenac Test (lower dose) DRUG

18-mg Single dose

Diclofenac Test (lower dose)

Diclofenac Test (upper dose) DRUG

35-mg Single dose

Diclofenac Test (upper dose)

Celecoxib 400 mg DRUG

Capsules 2 x 200 mg Single-dose

Celecoxib 400 mg

Placebo DRUG

Capsules 2 Single-dose

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Iroko Pharmaceuticals, LLC: lead

Study Sites (1)

Premier Research Group Limited

Austin, Texas, 78705, United States

Location

MeSH Terms

Conditions

Toothache

Interventions

Celecoxib

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Steven Jensen
• Organization: Iroko Pharmaceuticals, LLC

sjensen@iroko.com

267-546-3003

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2009
• First Posted: September 28, 2009
• Study Start: September 1, 2009
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 22, 2012
• Results First Posted: March 29, 2012

Record last verified: 2012-03

Locations

US (1)