NCT00964431

Phase 2 Study of Indomethacin Capsules to Treat Dental Pain

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Iroko Pharmaceuticals, LLC · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Dental Pain

Interventions

Type	Name	Description
DRUG	Celecoxib 400 mg	Capsules 2 x 200 mg Single-Dose
DRUG	Placebo	Capsules 2 Single-Dose
DRUG	Indomethacin Test (lower dose)	20-mg single dose
DRUG	Indomethacin Test (upper dose)	40-mg single dose

Timeline

• Start date: 2009-08-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2009-08-25
• Last updated: 2012-05-22
• Results posted: 2012-03-30

Locations

1 site across 1 country: United States