The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.
Information source: Purdue Pharma LP
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Low Back Pain
Intervention: Buprenorphine transdermal delivery system (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Purdue Pharma LP
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.
Clinical Details
Official title: A Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets in Patients With Chronic Back Pain
Study design: Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: 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 outcome: Average Pain Intensity and Patient Satisfaction With Medication for Pain scores (Patient Global Efficacy Rating)incidence of and time to early discontinuation due to lack of efficacy investigator’s assessment of therapeutic response dose level at the end of titration
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Rheumatology Associates of North Alabama, Huntsville, Alabama 35801, United States
Arizona Research Center, Phoenix, Arizona 85023, United States
Arthritis Center of Connecticut, Waterbury, Connecticut 06708, United States
Gainesville Clinical Research Center, Gainesville, Florida 32605, United States
Sarasota Arthritis Center, Sarasota, Florida 34239, United States
Palm Beach Research Center, West Palm Beach, Florida 33409, United States
University Clinical Research, Deland, Florida 32720, United States
Miami Research Associates, Miami, Florida 33173, United States
Coastal Medical Research, South Daytona Beach, Florida 32119, United States
Private Practice, Weston, Florida 33331, United States
Pain Management & Rehabilitation, Terre Haute, Indiana 47807, United States
Mid-America Rheumatology Consultants, Overland Park, Kansas 66209, United States
Riverhills Healthcare, Crestview Hills, Kentucky 41017, United States
Arthritis & Osteoporosis Treatment & Research Center, Jackson, Mississippi 39216, United States
Center for Pharmaceutical Research, Kansas City, Missouri 64114, United States
PrecisionMed, Inc., Las Vegas, Nevada 89128, United States
Cornerstone Research Care, High Point, North Carolina 27262, United States
Consultants for Clinical Research, Cincinnati, Ohio 45219, United States
Center for Clinical Research, Austin, Texas 78758, United States
The Arthritis Clinic of Northern Virginia, Arlington, Virginia 22206, United States
Evergreen Clinical Research, Edmonds, Washington 98026, United States
Private Practice, Wauwatosa, Wisconsin 53226, United States
Additional Information
Starting date: April 1999
Ending date: October 1999
Last updated: May 1, 2006
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