Safety and Efficacy Study of NTC-510 to Treat Pain Following Dental Surgery of Third Molars

Dental Pain Clinical Trial

Official title: A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study To Determine The Efficacy and Safety of Buprenorphine (as NTC-510 and NTC-510A) in Subjects With Pain Following Surgical Extraction of 1 or 2 Third Molars.

Status Terminated

Clinical Trial Summary

To evaluate the efficacy of a single dose NTC-510 or NTC-510A for dental pain following third molar extraction.

Clinical Trial Description

This is a Phase 2a, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the efficacy, concentration versus efficacy relationship, and safety of NTC-510 and NTC-510A at doses of 2.0, 1.0, and 0.5 mg.

The study will consist of 4 phases: screening (within 28 days before check-in), check-in (before surgery on Day 1), treatment (surgery, randomization, and treatment with study drug on Day 1), and follow up (Days 6 to 8). During the screening phase, screening procedures will be performed, subject eligibility will be determined, and written consent will be obtained. Subjects will then undergo dental surgery to extract 1 or 2 third molars (with at least 1 partial or complete bony mandibular extraction). The impaction score ([1] erupted in tissue, [2] broken soft tissue, [3] partial bony impaction, and [4] full bony impaction) will be collected for statistical adjustment should there be randomization imbalance. The surgery will be conducted according to standard clinical unit procedures. ;

Related Conditions & MeSH terms

• Dental Pain
• Toothache

• NCT number: NCT02161354
• Study type: Interventional
• Source: NanoSHIFT LLC
• Status: Terminated
• Phase: Phase 2
• Start date: June 2014
• Completion date: February 2016