NCT00945763

Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery

A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Adaptive Design, Single-Dose Study of Intravenous N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Alkermes, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery.

Detailed description

This is a randomized, double-blind, placebo-controlled, single center study in subjects who have undergone third molar extraction surgery. Eligible subjects will have surgical removal of \>2 third molars, of which at least 1 must be a complete or partial mandibular impaction. Each subject's study participation will consist of a screening visit (1-21 days prior to surgery), an inpatient evaluation period of 24 hours following dosing, and a follow-up phone call 3-5 days postdose.

Conditions

• Dental Pain

Interventions

Type	Name	Description
DRUG	N1539	30 mg
DRUG	placebo	tablets
DRUG	N1539	15 mg
DRUG	N1539	60 mg
DRUG	Motrin	400 mg

Timeline

• Start date: 2009-07-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2009-07-24
• Last updated: 2011-12-02

Locations

1 site across 1 country: United States