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

NCT02161354 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2017-06-23

No results posted yet for this study

Summary

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

Conditions

  • Dental Pain

Interventions

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

Sponsors & Collaborators

  • NanoSHIFT LLC

    lead INDUSTRY

Principal Investigators

  • William L Buchanan, MD,DDS · PPD Development, LP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02161354 on ClinicalTrials.gov