Status:
COMPLETED
Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
Lead Sponsor:
Alkermes, Inc.
Conditions:
Dental Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 mol...
Eligibility Criteria
Inclusion
- surgical extraction of \> 2 third molars with at least 1 complete or partial mandibular bony extraction
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT00945763
Start Date
July 1 2009
End Date
November 1 2009
Last Update
December 2 2011
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Jean Brown Research
Salt Lake City, Utah, United States, 84124