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Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015

NCT01125917 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2012-09-03

Study results available
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Summary

The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose \[up to BTDS 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief and tolerability.

Conditions

  • Back Pain Lower Back Chronic

Interventions

DRUG

Buprenorphine transdermal patch

Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.

DRUG

Buprenorphine transdermal patch

Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.

DRUG

Buprenorphine transdermal patch

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.

Sponsors & Collaborators

  • Purdue Pharma LP

    lead INDUSTRY

Principal Investigators

  • Deborah L Steiner, MD, MS · Purdue Pharma LP

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-06-30
Primary Completion
2005-09-30
Completion
2008-01-31

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 NCT01125917 on ClinicalTrials.gov