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

Study Overview
=================
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 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.

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

Conditions
-----------------
Dental Pain

Intervention / Treatment
-----------------
* Drug: N1539
* Drug: placebo
* Drug: N1539
* Drug: N1539
* Drug: Motrin


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br> | Drug: placebo<br>* tablets<br>* Other names: sugar pill;|
| Experimental: N1539 15 mg<br> | Drug: N1539<br>* 15 mg<br>* Other names: meloxicam;|
| Experimental: N1539 30 mg<br> | Drug: N1539<br>* 30 mg<br>* Other names: meloxicam;|
| Experimental: N1539 60 mg<br> | Drug: N1539<br>* 60 mg<br>* Other names: meloxicam;|
| Active Comparator: Motrin<br> | Drug: Motrin<br>* 400 mg<br>* Other names: ibuprofen;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity Difference at End of Study |  | 0-24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Onset of action |  | 0-1 hour | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dental Pain