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

Dental Pain Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00945763
Study type Interventional
Source Alkermes, Inc.
Contact
Status Completed
Phase Phase 2
Start date July 2009
Completion date November 2009
View Details
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