NCT00707057

Ibuprofen Extended-Release Dental Pain Study

Ibuprofen 600 mg Extended-Release (ER) Multiple-Dose Dental Pain Study

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: SCOLR Pharma, Inc. · Industry
• Sex: All
• Age: 16 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth.

Detailed description

This is a single-center, multiple-dose, randomized, placebo-controlled, double-blinded, parallel group trial to evaluate the efficacy and safety of multiple doses of Ibuprofen 600 mg Extended-Release Tablets in a study of dental pain following extraction of third molar teeth. The surgery will consist of surgical extraction of 1-2 impacted third molars, of which one must be a mandibular impaction that is partially impacted in either tissue or bone. Subjects will be stratified according to baseline pain intensity, as rated on an 11-point pain intensity numerical rating scale (PI-NRS)and gender.

Conditions

• Pain
• Post-Operative Pain
• Third Molar Extraction

Interventions

Type	Name	Description
DRUG	Ibuprofen 600 mg Extended-Release Tablets	Ibuprofen 600 mg Extended-Release Tablet: One 600 mg tablet taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.
DRUG	Placebo	Placebo: One matching placebo tablet was taken orally every 12 hours or twice daily (BID). Each dose was administered with at least 6 ounces of water. Dose 1 was administered at hour 0, Dose 2 was administered at hour 12, Dose 3 was administered at hour 24 and Dose 4 was administered at hour 36.

Timeline

• Start date: 2008-06-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-06-30
• Last updated: 2011-03-24
• Results posted: 2011-03-23

Locations

1 site across 1 country: United States