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
Verified date | November 2011 |
Source | Alkermes, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery.
Status | Completed |
Enrollment | 230 |
Est. completion date | November 2009 |
Est. primary completion date | November 2009 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | Jean Brown Research | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Alkermes, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain Intensity Difference at End of Study | 0-24 hours | No | |
Secondary | Onset of action | 0-1 hour | No |
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