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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Alkermes, Inc.
• Treatments: Ibuprofen; Meloxicam

Criteria

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