Clinical trial NCT00490919: Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Chronic Low Back Pain
Official title: Multi-center, Randomized, Double-blind, Placebo-controlled With Open Label run-in Study Assessing Efficacy, Tolerability, Safety of BTDS 10 or 20 Compared to Placebo in Opioid-naïve Subjects With Moderate to Severe, Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Chronic pain
opioid
transdermal
Moderate to severe chronic low back pain
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2007-06-25
Enrollment: 539
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 determine the analgesic efficacy and safety of Buprenorphine Transdermal System (BTDS) 10 and 20 compared to placebo in opioid-naïve subjects with moderate to severe chronic low back pain. The double-blind treatment intervention duration is 12 weeks, during which time supplemental analgesic medication (immediate-release oxycodone for the first 6 days post-randomization and acetaminophen or ibuprofen for the remainder of the double-blind phase) will be provided to all subjects in addition to study drug.

Detailed description: Buprenorphine is a synthetic opioid analgesic with over 25 years of international clinical experience indicating it to be safe and effective in a variety of therapeutic settings for the relief of moderate to severe pain. BTDS is a transdermal system formulation that is designed to deliver a consistent and a steady dose of buprenorphine over a 7-day period with limited blood concentration fluctuation.

Eligibility criteria: Inclusion Criteria:

* Subjects with moderate to severe chronic low back pain (lasting several hours daily) as their predominant pain condition for at least 3 months prior to screening,
* Subjects treated within the 14 days prior to screening with nonopioid therapy only, or with therapy including opioids at a dose of \<5 mg oxycodone (or equivalent) per day,
* Subjects whose low back pain is not adequately controlled with non-opioid analgesic medication and who the Investigator feels are appropriate candidates for around-the-clock opioid therapy

Exclusion Criteria:

* Subjects who had a surgical procedure directed towards the source of back pain within 6 months of screening or planned during the study conduct period,
* Subjects who are allergic to buprenorphine or who had a history of allergies to other opioids,
* Subjects who have allergies or other contraindications to transdermal delivery systems or patch adhesives.

Other protocol-specific inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Average Pain Over the Last 24 Hours Scores at Week 12 of the Double-blind Phase.
timeFrame: Prerandomization phase consisted of a 6-10 day screening period and a <27 day open-label run-in period; and a 12-week double-blind phase.
Secondary outcomes:
measure: The Mean Daily Number of Tablets of Nonopioid Supplemental Analgesic Medications Taken During Weeks 2 Through 12 of the Double-blind Phase
timeFrame: weeks 2-12
measure: The Sleep Disturbance Subscale in the Medical Outcome Study (MOS) Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
timeFrame: Weeks 4, 8, 12 of double-blind phase
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Research Facility
state: Alabama
city: Mobile
country: United States
facility: Coastal Clinical Research, Inc.
state: Alabama
city: Chandler
country: United States
facility: Radiant Research; Phoenix Southeast
state: Arizona
city: Phoenix
country: United States
facility: Arizona Research Center Inc.
state: Arizona
city: Phoenix
country: United States
facility: Research Facility
state: Arizona
city: Phoenix
country: United States
facility: Research Facility
state: Arizona
city: Anaheim
country: United States
facility: Research Facility
state: California
city: Beverly Hills
country: United States
facility: Lovelace Scientific Resources, Inc.
state: California
city: Carmichael
country: United States
facility: Research Facility
state: California
city: City of Industry
country: United States
facility: Advance Care Medical Group
state: California
city: Downey
country: United States
facility: Research Facility
state: California
city: Foothill Ranch
country: United States
facility: Research Facility
state: California
city: Sacramento
country: United States
facility: Research Facility
state: California
city: San Luis Obispo
country: United States
facility: Research Facility
state: California
city: Littleton
country: United States
facility: Research Facility
state: Colorado
city: Stamford
country: United States
facility: Research Facility
state: Connecticut
city: Clearwater
country: United States
facility: Clinical Research of West Florida
state: Florida
city: Clearwater
country: United States
facility: Research Facility
state: Florida
city: Deland
country: United States
facility: University Clinical Research
state: Florida
city: Delray Beach
country: United States
facility: Arthritis Associates of S. FL
state: Florida
city: Ft. Myers
country: United States
facility: Research Facility
state: Florida
city: Holly Hill
country: United States
facility: Century Clinical Research, Inc.
state: Florida
city: Jupiter
country: United States
facility: Research Facility
state: Florida
city: Largo
country: United States
facility: Research Facility
state: Florida
city: Merritt Island
country: United States
facility: Research Facility
state: Florida
city: Miami
country: United States
facility: Pharmax Research Clinic
state: Florida
city: Orlando
country: United States
facility: Research Facility
state: Florida
city: Plantation
country: United States
facility: Research Facility
state: Florida
city: Port Orange
country: United States
facility: Research Facility
state: Florida
city: Tampa
country: United States
facility: Clinical Research of West Flor
state: Florida
city: Tampa
country: United States
facility: Research Facility
state: Florida
city: West Palm Beach
country: United States
facility: Research Facility
state: Florida
city: Atlanta
country: United States
facility: Independent Neurodiagnostic Clinic
state: Georgia
city: Dawsonville
country: United States
facility: Research Facility
state: Georgia
city: Decatur
country: United States
facility: Druid Oaks Health Center
state: Georgia
city: Marietta
country: United States
facility: Research Facility
state: Georgia
city: Marietta
country: United States
facility: Research Facility
state: Georgia
city: Honolulu
country: United States
facility: Research Facility
state: Hawaii
city: Boise
country: United States
facility: Research Facility
state: Idaho
city: Indianapolis
country: United States
facility: Rehabilitation Association of IN
state: Indiana
city: Overland Park
country: United States
facility: Research Facility
state: Kansas
city: Prairie Village
country: United States
facility: CTT Consultants, Inc.
state: Kansas
city: Baton Rouge
country: United States
facility: Dolby Research, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Research Facility
state: Louisiana
city: New Orleans
country: United States
facility: Research Facility
state: Louisiana
city: Shreveport
country: United States
facility: Research Facility
state: Louisiana
city: Brockton
country: United States
facility: Research Facility
state: Massachusetts
city: Haverhill
country: United States
facility: East Coast Clinical Research
state: Massachusetts
city: Springfield
country: United States
facility: Research Facility
state: Massachusetts
city: Bay City
country: United States
facility: Research Facility
state: Michigan
city: Biloxi
country: United States
facility: Research Facility
state: Mississippi
city: Florissant
country: United States
facility: Research Facility
state: Missouri
city: St. Louis
country: United States
facility: Research Facility
state: Missouri
city: St. Louis
country: United States
facility: Research Facility
state: Missouri
city: St. Louis
country: United States
facility: Sports Med Consultants, PC
state: Missouri
city: Henderson
country: United States
facility: Research Facility
state: Nevada
city: Las Vegas
country: United States
facility: Research Facility
state: Nevada
city: Albuquerque
country: United States
facility: Lovelace Scientific Resources
state: New Mexico
city: New York
country: United States
facility: Research Facility
state: New York
city: New York
country: United States
facility: Research Facility
state: New York
city: Charlotte
country: United States
facility: Research Facility
state: North Carolina
city: Greensboro
country: United States
facility: Research Facility
state: North Carolina
city: Morgantown
country: United States
facility: Research Facility
state: North Carolina
city: Cincinatti
country: United States
facility: Community Research
state: Ohio
city: Cincinnati
country: United States
facility: Research Facility
state: Ohio
city: Columbus
country: United States
facility: Research Facility
state: Ohio
city: Columbus
country: United States
facility: Research Facility
state: Ohio
city: Toledo
country: United States
facility: Research Facility
state: Ohio
city: Oklahoma City
country: United States
facility: Research Facility
state: Oklahoma
city: Eugene
country: United States
facility: Research Facility
state: Oregon
city: Medford
country: United States
facility: Research Facility
state: Oregon
city: Altoona
country: United States
facility: Research Facility
state: Pennsylvania
city: Chicora
country: United States
facility: Research Facility
state: Pennsylvania
city: Duncansville
country: United States
facility: Research Facility
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Research Facility
state: Pennsylvania
city: West Reading
country: United States
facility: Research Facility
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center for Clinical Research
state: Rhode Island
city: Anderson
country: United States
facility: Anderson Family Care, PA
state: South Carolina
city: Dallas
country: United States
facility: KRK Medical Research
state: Texas
city: Killeen
country: United States
facility: Research Facility
state: Texas
city: Plano
country: United States
facility: Research Facility
state: Texas
city: San Antonio
country: United States
facility: Research Facility
state: Texas
city: San Antonio
country: United States
facility: Research Facility
state: Texas
city: Sugarland
country: United States
facility: Research Facility
state: Texas
city: Salt Lake City
country: United States
facility: Research Facility
state: Utah
city: Roanoke
country: United States
facility: Research Facility
state: Virginia
Study officials:
References:
citation: Steiner DJ, Sitar S, Wen W, Sawyerr G, Munera C, Ripa SR, Landau C. Efficacy and safety of the seven-day buprenorphine transdermal system in opioid-naive patients with moderate to severe chronic low back pain: an enriched, randomized, double-blind, placebo-controlled study. J Pain Symptom Manage. 2011 Dec;42(6):903-17. doi: 10.1016/j.jpainsymman.2011.04.006. Epub 2011 Sep 25.