NCT02161354

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: NanoSHIFT LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Dental Pain

Interventions

Type	Name	Description
DRUG	NTC-510 capsules	Subjects will be randomized to one of 3 groups and NTC-510 will be given as a single oral dose of 2.0 mg, a split dose of 2.0 mg followed by 2.0 mg an hour later, or 6.0 mg for acute pain relief (PR) following third molar extraction.
DRUG	Placebo Capsules	Subjects will be randomized to one of 3 groups and placebo capsules will be given as a single oral dose of for acute dental pain following third molar extraction.
DRUG	NTC-510A Capsules	Subjects will be randomized to one of 3 groups where NTC-510A or placebo will be given as a single oral dose of 2.0, 4.0, or 6 mg for acute pain relief (PR) following third molar extraction

Timeline

• Start date: 2014-06-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2014-06-11
• Last updated: 2017-06-23

Locations

1 site across 1 country: United States