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

Alkermes, Inc.230 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

230

Conditions

Dental Pain

Interventions

N1539DRUG

30 mg

placeboDRUG

tablets

N1539DRUG

15 mg

N1539DRUG

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Jean Brown Research

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Pain Intensity Difference at End of Study

Time frame: 0-24 hours

Secondary Outcomes

Onset of action

Time frame: 0-1 hour

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.