Phase 2 Study of Indomethacin Capsules to Treat Dental Pain

Dental Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964431
• Other study ID #: IND2-08-03
• Status: Completed
• Phase: Phase 2
• First received: August 24, 2009
• Last updated: May 15, 2012
• Start date: August 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 Indomethacin Test Formulation Capsules are safe and effective for the treatment of dental pain.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• 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 for at least 8 hours after dosing of the study drug

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, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Pain
• Toothache

Intervention

Drug:
• Celecoxib 400 mg
Capsules 2 x 200 mg Single-Dose
• Placebo
Capsules 2 Single-Dose
• Indomethacin Test (lower dose)
20-mg single dose
• Indomethacin Test (upper dose)
40-mg 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 8 Hours.	Total patient pain relief was assessed as a time-weighted sum of the patient pain assessments at each individual time point from 0-8 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 32.	8 hours	No