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Efficacy Study to Evaluate Buprenorphine HCl Buccal Film in Opioid-Naive Subjects

NCT01633944 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 752

Last updated 2017-02-27

Study results available
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Summary

The purpose of this study is to determine if buprenorphine hydrochloride (HCl) buccal film is effective in treating opioid-naive subjects, with moderate to severe chronic low back pain (CLBP), who require continuous around-the-clock (ATC) pain relief for an extended period of time.

Conditions

  • Low Back Pain

Interventions

DRUG

Buprenorphine

Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily

DRUG

Placebo

Matching Placebo Buccal Film twice daily

Sponsors & Collaborators

  • BioDelivery Sciences International

    lead INDUSTRY

Principal Investigators

  • M. Todd Kirby, PhD · Endo Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT01633944 on ClinicalTrials.gov