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

Alkermes

Status and phase: Completed; Phase 2

Conditions: Dental Pain

Treatments: Drug: N1539; Drug: Motrin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00945763

N1539-02

Details and patient eligibility

About

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

Full 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 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.

Enrollment: 230 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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230 participants in 5 patient groups, including a placebo group

placebo

Placebo Comparator group

Treatment:

Drug: placebo

N1539 15 mg

Experimental group

Treatment:

Drug: N1539

Drug: N1539

Drug: N1539

N1539 30 mg

Experimental group

Treatment:

Drug: N1539

Drug: N1539

Drug: N1539

N1539 60 mg

Experimental group

Treatment:

Drug: N1539

Drug: N1539

Drug: N1539

Motrin

Active Comparator group

Treatment:

Drug: Motrin