Single Dose Study of N1539 in the Treatment of Pain Secondary to Dental Impaction Surgery
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To evaluate the safety and efficacy of single IV doses of N1539 after dental impaction surgery.
Condition or disease
Drug: N1539Drug: placeboDrug: Motrin
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.
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
surgical extraction of > 2 third molars with at least 1 complete or partial mandibular bony extraction
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