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Efficacy and Safety Study of Buprenorphine HCl Buccal Film in Subjects With Low Back Pain

NCT01256450 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2017-02-27

Study results available
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Summary

The purpose of this study is to determine whether buprenorphine hydrochloride (HCl) buccal film is effective and safe in the treatment of chronic low back pain (CLBP).

Conditions

  • Pain
  • Low Back Pain

Interventions

DRUG

Buprenorphine

buccal soluble film; applied to the buccal mucosa twice daily

DRUG

Placebo

buccal soluble film; applied to the buccal mucosa twice daily

Sponsors & Collaborators

  • BioDelivery Sciences International

    lead INDUSTRY

Principal Investigators

  • Andrew Finn, PharmD · BioDelivery Sciences International, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-11-30
Primary Completion
2011-07-31
Completion
2011-07-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT01256450 on ClinicalTrials.gov