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NCT00315887 Clinical Trial

The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.

Chronic Low Back Pain Clinical Trial

Official title:
A Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets in Patients With Chronic Back Pain

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00315887
Other study ID # BP98-1201
Secondary ID
Status Completed
Phase Phase 3
First received April 18, 2006
Last updated May 1, 2006
Start date April 1999
Est. completion date October 1999

Study information
Verified date April 2006
Source Purdue Pharma LP
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) will be provided to all subjects in addition to study drug.

Description:

Buprenorphine is a synthetic opioid analgesic with over twenty-five years of international clinical experience indicating it to be safe and effective in a variety of therapeutic situations for the relief of moderate to severe pain. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.

Recruitment information / eligibility
Status Completed
Enrollment 250
Est. completion date October 1999
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- clinical evidence of chronic back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, osteoarthritis, or other, similar nonmalignant conditions.

- back pain treated with an opioid-containing analgesic at a dose equal to or less than the equivalent of 90 mg of oral morphine per day or 12 or fewer capsules or tablets of an opioid combination analgesic per day.

Exclusion Criteria:

- receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets per day of short-acting opioid-containing products.

- scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.

Other protocol-specific exclusion/inclusion criteria may apply.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Buprenorphine transdermal delivery system

Locations
Country Name City State
United States The Arthritis Clinic of Northern Virginia Arlington Virginia
United States Center for Clinical Research Austin Texas
United States Consultants for Clinical Research Cincinnati Ohio
United States Riverhills Healthcare Crestview Hills Kentucky
United States University Clinical Research Deland Florida
United States Evergreen Clinical Research Edmonds Washington
United States Gainesville Clinical Research Center Gainesville Florida
United States Cornerstone Research Care High Point North Carolina
United States Rheumatology Associates of North Alabama Huntsville Alabama
United States Arthritis & Osteoporosis Treatment & Research Center Jackson Mississippi
United States Center for Pharmaceutical Research Kansas City Missouri
United States PrecisionMed, Inc. Las Vegas Nevada
United States Miami Research Associates Miami Florida
United States Mid-America Rheumatology Consultants Overland Park Kansas
United States Arizona Research Center Phoenix Arizona
United States Sarasota Arthritis Center Sarasota Florida
United States Coastal Medical Research South Daytona Beach Florida
United States Pain Management & Rehabilitation Terre Haute Indiana
United States Arthritis Center of Connecticut Waterbury Connecticut
United States Private Practice Wauwatosa Wisconsin
United States Palm Beach Research Center West Palm Beach Florida
United States Private Practice Weston Florida

Sponsors (1)
Lead Sponsor Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Patient Satisfaction With Medication for Pain and Average Pain Intensity scores on days 0, 7, 14, 21, 28, 35, 42, 49, 56 and, if applicable, at early termination.
Secondary Average Pain Intensity and Patient Satisfaction With Medication for Pain scores (Patient Global Efficacy Rating)
Secondary incidence of and time to early discontinuation due to lack of efficacy
Secondary investigator’s assessment of therapeutic response
Secondary dose level at the end of titration
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