Clinical trial NCT00315874: The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain.
Official title: Safety and Efficacy of Buprenorphine TDS (Transdermal Delivery System) 5, 10 and 20 Applied Every 7 Days for Sixty Days vs. 5 mg Oxycodone/325 mg Acetaminophen Tablets q6h Prn vs. Placebo in Patients With Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Back Pain
Keywords: chronic back pain
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 chronic low back 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 if applicable, 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: Phoenix
country: United States
facility: Hawthorne & York, Intl, Ltd
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research & Education
state: Arizona
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: Atlanta
country: United States
facility: Atlanta Research Center
state: Georgia
city: Indianapolis
country: United States
facility: Rheumatology Associates, Inc.
state: Indiana
city: Kalamazoo
country: United States
facility: Westside Family Medical Center
state: Michigan
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: New York
country: United States
facility: The New York Hospital Cornell Medical Center
state: New York
city: Raleigh
country: United States
facility: NC Clinical Research, Inc.
state: North Carolina
city: Winston-Salem
country: United States
facility: Pain Control Ctr Bowman Gray School of Med
state: North Carolina
city: Dallas
country: United States
facility: Metroplex Clinical Research Center
state: Texas
Study officials:
References: