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

Phase 2

Completed

• Conditions: Dental Pain
• Interventions: Drug: placebo; Drug: N1539; Drug: Motrin

• Registration Number: NCT00945763
• Lead Sponsor: Alkermes, Inc.

Brief 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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Disposition First Submitted: 2011-06-24
• Status Verified: 2011-11
• Disposition First Submitted QC: 2011-11-28
• Last Update Submitted: 2011-11-28
• Disposition First Posted: 2011-12-02
• Last Update Posted: 2011-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• surgical extraction of > 2 third molars with at least 1 complete or partial mandibular bony extraction

Exclusion Criteria

• allergic response to aspirin, NSAIDs, acetaminophen or hydrocodone
• use of aspirin or other analgesics within 48 hours prior to surgery
• current or recent history of drug or alcohol abuse
• any medication for treatment of chronic pain
• clinically significant abnormality on screening laboratory test active or recent history of peptic ulcer disease or GI bleeding
• prior abdominal surgery, except uncomplicated appendectomy
• any other surgical procedure within 30 days before administration of study drug
• pregnancy or breastfeeding
• untreated hypertension; SBP > 140 mmHg or DBP > 95 mmHg

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	-
N1539 15 mg	N1539	-
N1539 30 mg	N1539	-
N1539 60 mg	N1539	-
Motrin	Motrin	-

Primary Outcome Measures

Name	Time	Method
Pain Intensity Difference at End of Study	0-24 hours

Secondary Outcome Measures

Name	Time	Method
Onset of action	0-1 hour

Trial Locations

Locations (1)

Jean Brown Research; 🇺🇸 Salt Lake City, Utah, United States