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Study of Buprenorphine HCl Buccal Film in the Treatment of Dental Pain

NCT00941304 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2017-02-27

Study results available
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Summary

The purpose of this study is to assess the activity of buprenorphine hydrochloride (HCl) buccal film in the treatment of dental pain.

Conditions

  • Dental Pain

Interventions

DRUG

Oxycodone

Single-dose of over-encapsulated oral 5-mg oxycodone capsule

DRUG

Buprenorphine

Single-dose of buprenorphine HCl buccal film

DRUG

Placebo Film

Single-dose of placebo buccal film

DRUG

Placebo Capsule

Single-dose of oral placebo capsule

Sponsors & Collaborators

  • BioDelivery Sciences International

    lead INDUSTRY

Principal Investigators

  • David Blum, MD · BioDelivery Sciences International

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2009-11-30
Completion
2009-11-30

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 NCT00941304 on ClinicalTrials.gov