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

Completed · Phase 2 · Has a placebo group

Conditions studied: Dental Pain

In brief

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

Key facts

Study ID

NCT00945763

Run by

Alkermes, Inc.

People needed

230

Starts

2009-07-01

Expected to finish

2009-11-01

Last updated by the study team

2011-12-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Jean Brown Research — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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