Clinical trial NCT00315848: The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Osteoarthritis Pain.
Official title: A Multi-Center, Randomized, Double-Blind, Parallel Group Study of the Safety and Efficacy of Buprenorphine Transdermal Delivery System Vs. Oxycodone/Acetaminophen Tablets Vs. Placebo in Patients With Chronic Pain Due to Osteoarthritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis
Keywords: chronic pain
osteoarthritis
opioid
transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2006-04-19
Enrollment: 225
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 demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with osteoarthritis pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 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:

* unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking \</=2 short-acting opioid doses per day.
* taking \>/=3 opioid doses per day with or without acceptable pain control.

Exclusion Criteria:

* receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid.
* scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period.

Other protocol-specific exclusion/inclusion criteria may apply.

Primary outcomes:
measure: Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or at early termination.
Secondary outcomes:
measure: Brief Pain Inventory
measure: dropouts due to lack of efficacy
measure: MOS health survey
measure: VAS pain intensity
measure: therapeutic response
measure: patient preference
measure: daily patient diary
measure: and number of oxycodone/acetaminophen or placebo tablets taken
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Rheumatology Associates of North Alabama
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research and Education
state: Arizona
city: Phoenix
country: United States
facility: Phoenix Center for Clinical Research
state: Arizona
city: Westminster
country: United States
facility: Western Integrated Pain Treatment Centers
state: Colorado
city: Gainesville
country: United States
facility: Gainesville Clinical Research Center
state: Florida
city: Plantation
country: United States
facility: Park Place Therapeutic Center
state: Florida
city: Evansville
country: United States
facility: MediSphere Medical Research Center, L.L.C.
state: Indiana
city: Albany
country: United States
facility: Stratton VA Medical Center
state: New York
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
city: San Antonio
country: United States
facility: Arthritis Diagnostic and Treatment Center
state: Texas
Study officials:
References: