Clinical trial NCT00315887: The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.
Official title: A Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets in Patients With Chronic Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Low Back Pain
Keywords: low back pain
opioid
transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2006-04-19
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: 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 outcomes:
measure: Average Pain Intensity and Patient Satisfaction With Medication for Pain scores (Patient Global Efficacy Rating)
measure: incidence of and time to early discontinuation due to lack of efficacy
measure: investigator's assessment of therapeutic response
measure: dose level at the end of titration
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center
state: Arizona
city: Waterbury
country: United States
facility: Arthritis Center of Connecticut
state: Connecticut
city: Deland
country: United States
facility: University Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Gainesville Clinical Research Center
state: Florida
city: Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Center
state: Florida
city: South Daytona Beach
country: United States
facility: Coastal Medical Research
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Weston
country: United States
facility: Private Practice
state: Florida
city: Terre Haute
country: United States
facility: Pain Management & Rehabilitation
state: Indiana
city: Overland Park
country: United States
facility: Mid-America Rheumatology Consultants
state: Kansas
city: Crestview Hills
country: United States
facility: Riverhills Healthcare
state: Kentucky
city: Jackson
country: United States
facility: Arthritis & Osteoporosis Treatment & Research Center
state: Mississippi
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Las Vegas
country: United States
facility: PrecisionMed, Inc.
state: Nevada
city: High Point
country: United States
facility: Cornerstone Research Care
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Austin
country: United States
facility: Center for Clinical Research
state: Texas
city: Arlington
country: United States
facility: The Arthritis Clinic of Northern Virginia
state: Virginia
city: Edmonds
country: United States
facility: Evergreen Clinical Research
state: Washington
city: Wauwatosa
country: United States
facility: Private Practice
state: Wisconsin
Study officials:
References: