Clinical trial NCT00314652: Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.
Official title: A Double-Blind Placebo-Controlled Study of Buprenorphine Transdermal System (BTDS) in Patients With Osteoarthritis of the Hip or Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: Osteoarthritis
chronic pain
opioid
transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2006-04-14
Enrollment: 260
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 in subjects with osteoarthritis pain. The double-blind treatment intervention duration is 28 days.

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:

* documented history and/or radiologic evidence of chronic osteoarthritis of the hip or knee.
* receiving opioid therapy for osteoarthritis-related pain within the past year or have experienced pain that was inadequately controlled with a full standard dose of NSAIDs.

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 or capsules 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: Percentage of patients who were treated successfully for pain management
measure: a patient fails if he or she discontinues early due to ineffective treatment or has a Patient Satisfaction Scale score of poor or fair at the final visit
Secondary outcomes:
measure: Average pain intensity and patient satisfaction scores
measure: Incidence of early discontinuation due to lack of efficacy
measure: Time to early discontinuation due to lack of efficacy
measure: Dose level at end of titration
measure: Investigator's assessment of therapeutic response
measure: Diary pain scores
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Hawthorne & York, International, Ltd.
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center, LLC
state: Arizona
city: Tucson
country: United States
facility: ACRC/Arizona Clinical Research
state: Arizona
city: Tucson
country: United States
facility: Advanced Clinical Therapeutics
state: Arizona
city: San Diego
country: United States
facility: San Diego Arthritis and Osteoporosis Research
state: California
city: San Diego
country: United States
facility: Scripps Clinic Rancho Bernardo
state: California
city: Trumbull
country: United States
facility: Clinical Research Consultants, Inc.
state: Connecticut
city: Clearwater
country: United States
facility: Tampa Bay Medical Research, Inc.
state: Florida
city: Deland
country: United States
facility: University Clinical Research
state: Florida
city: Gainesville
country: United States
facility: Gainesville Clinical Research Center
state: Florida
city: Jacksonville
country: United States
facility: Physicians Research Associates Jacksonville
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Weston
country: United States
facility: Gold Coast Research, Inc.
state: Florida
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Kalamazoo
country: United States
facility: Westside Family Medical Center
state: Michigan
city: Kansas City
country: United States
facility: Center for Pharmaceutical Research
state: Missouri
city: Passaic
country: United States
facility: NJP Clinical Research
state: New Jersey
city: Winston-Salem
country: United States
facility: PW Clinical Research, LLC
state: North Carolina
city: Beaverbrook
country: United States
facility: New Century Research Center, Ltd.
state: Ohio
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Memphis
country: United States
facility: Mid-South Clinical Research Institute
state: Tennessee
city: Salt Lake City
country: United States
facility: Advanced Clinical Research
state: Utah
Study officials:
References: