Clinical trial NCT01125917: Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
Official title: A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release Vs Buprenorphine Transdermal System (BTDS) 5 in Subjects With Moderate to Severe Low Back Pain: A 52-Week Open-label Extension Phase of BUP3015
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Back Pain Lower Back Chronic
Keywords: Low back pain
Opioid
Transdermal
Lead sponsor: Purdue Pharma LP
Sponsor class: INDUSTRY
First posted: 2010-05-19
Enrollment: 354
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the extension phase is to evaluate the long-term safety and tolerability of buprenorphine transdermal system (BTDS). Subjects begin the extension phase on BTDS 5 mcg/h and may up- or down-titrate the dose \[up to BTDS 20 micrograms (mcg) / hour (h)\] depending on adequate pain relief and tolerability.

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 situations for the relief of moderate to severe pain.

Eligibility criteria: Inclusion Criteria:

* Subjects who completed all visits of the double-blind phase on study drug, and subjects who discontinued study drug due to lack of therapeutic effect in the double-blind phase but completed all visits of the double-blind phase off study drug are eligible to enroll in the extension phase.
* For subjects entering the extension, 4 electrocardiograms (ECGs) are required at entry if none were collected prior to randomization while on BTDS 20. NOTE: Subjects with any 1 QT data corrected for heart rate using the Fridericia formula (QTcF) interval ≥ 500 milliseconds (msec) would be discontinued from the extension phase

Exclusion Criteria:

* Subjects requiring long-acting opioid analgesics \[once- or twice-daily dosing with a every (q) 24 hours (h) or q12h drug\] or transdermal fentanyl during the extension phase should be discontinued from the study.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) as a Measure of Safety
timeFrame: 52-week extension phase
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Pain Center
state: Alabama
city: Birmingham
country: United States
facility: Arthritis Clinical Intervention Program
state: Alabama
city: Haleyville
country: United States
facility: Winston Physician Services, Inc
state: Alabama
city: Phoenix
country: United States
facility: Arizona Research Center Inc
state: Arizona
city: Phoenix
country: United States
facility: Radiant Research
state: Arizona
city: Tucson
country: United States
facility: Advanced Clinical Therapeutics
state: Arizona
city: Hot Springs
country: United States
facility: Hot Springs Pain Clinic
state: Arkansas
city: Anaheim
country: United States
facility: NuLife Clinical Research, Inc.
state: California
city: Beverly Hills
country: United States
facility: Lovelace Scientific Resources
state: California
city: Carmichael
country: United States
facility: Northern California Research Corp
state: California
city: Chula Vista
country: United States
facility: International Clinical Research Network
state: California
city: Fountain Valley
country: United States
facility: Shreenath Clinical Service
state: California
city: Sacramento
country: United States
facility: U of Calif at Davis, Med Ctr, Pain Management Center
state: California
city: San Diego
country: United States
facility: Accelovance
state: California
city: Pueblo
country: United States
facility: Southern Colorado Clinic
state: Colorado
city: Chiefland
country: United States
facility: Chiefland Medical Center
state: Florida
city: Deland
country: United States
facility: University Clinical Research Deland
state: Florida
city: Jupiter
country: United States
facility: Drug Study Institute
state: Florida
city: Largo
country: United States
facility: Innovative Research of West Florida, Inc.
state: Florida
city: Ocala
country: United States
facility: Renstar Medical
state: Florida
city: Ormond Beach
country: United States
facility: Peninsula Research Inc.
state: Florida
city: Palm Harbor
country: United States
facility: The Arthritis Center
state: Florida
city: Pembroke Pines
country: United States
facility: University Clinical Research, Inc.
state: Florida
city: Plantation
country: United States
facility: Gold Coast Research, LLC
state: Florida
city: West Palm Beach
country: United States
facility: Palm Beach Research Center
state: Florida
city: Marietta
country: United States
facility: Georgia Medical Research Institute
state: Georgia
city: Stockbridge
country: United States
facility: Atlanta Knee & Shoulder Clinic
state: Georgia
city: Boise
country: United States
facility: Pain Care Boise
state: Idaho
city: Meridian
country: United States
facility: Idaho Arthritis and Osteoporosis Center
state: Idaho
city: Chicago
country: United States
facility: Pain and Rehabilitation Clinic of Chicago
state: Illinois
city: Evansville
country: United States
facility: GFI Research Center
state: Indiana
city: Evansville
country: United States
facility: MediSphere Medical Research Center, LLC
state: Indiana
city: Dubuque
country: United States
facility: Medical Associates Clinics
state: Iowa
city: Overland Park
country: United States
facility: Vince and Associates Clinical Research
state: Kansas
city: Prairie Village
country: United States
facility: CTT, Inc.
state: Kansas
city: Madisonville
country: United States
facility: Commonwealth Biomedical Research, LLC
state: Kentucky
city: Metairie
country: United States
facility: New Orleans Clinical Trial Management Inc.
state: Louisiana
city: New Orleans
country: United States
facility: Louisiana Research Associates, Inc.
state: Louisiana
city: New Orleans
country: United States
facility: Best Clinical Trials, LLC
state: Louisiana
city: New Orleans
country: United States
facility: Research Center of Louisiana
state: Louisiana
city: Baltimore
country: United States
facility: Sinai Hospital of Baltimore
state: Maryland
city: Springfield
country: United States
facility: Future Care Studies
state: Massachusetts
city: Kalamazoo
country: United States
facility: Rheumatology PC
state: Michigan
city: Saint Joseph
country: United States
facility: Lake Michigan Clinical Research & Consulting, Inc.
state: Michigan
city: St Louis
country: United States
facility: Medex Healthcare Research Inc
state: Missouri
city: St Louis
country: United States
facility: HealthCare Research
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research, LLC
state: Nebraska
city: Henderson
country: United States
facility: Lovelace Scientific Resources
state: Nevada
city: North Las Vegas
country: United States
facility: Pivotal Research Centers
state: Nevada
city: New York
country: United States
facility: Research Across America
state: New York
city: Charlotte
country: United States
facility: Pain and Orthopedic Neurology , Charlotte Spine Center,
state: North Carolina
city: Charlotte
country: United States
facility: Metrolina Medical Research
state: North Carolina
city: Durham
country: United States
facility: Triangle Orthopaedic Associates
state: North Carolina
city: Greensboro
country: United States
facility: Pharmquest
state: North Carolina
city: Morgantown
country: United States
facility: MedArk Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC
state: North Carolina
city: Winston Salem
country: United States
facility: Center for Clinical Research
state: North Carolina
city: Bismark
country: United States
facility: Odyssey Research
state: North Dakota
city: Oklahoma City
country: United States
facility: COR Clinical Research, LLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Associated Medical Services Inc
state: Oklahoma
city: Altoona
country: United States
facility: Keystone Clinical Research
state: Pennsylvania
city: Bethlehem
country: United States
facility: Valley Pain Specialists
state: Pennsylvania
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Mechanicsburg
country: United States
facility: Central Pennsylvania Clinical Research
state: Pennsylvania
city: Shippensburg
country: United States
facility: BioMedical Research Associates
state: Pennsylvania
city: State College
country: United States
facility: University Orthopedics Center
state: Pennsylvania
city: Cranston
country: United States
facility: New England Center Clinical Research
state: Rhode Island
city: Warwick
country: United States
facility: Omega Medical Research
state: Rhode Island
city: Orangeburg
country: United States
facility: The Arthritis and Osteoporosis Center
state: South Carolina
city: Watertown
country: United States
facility: Brown Clinic
state: South Dakota
city: Bristol
country: United States
facility: Holston Medical Group
state: Tennessee
city: Bristol
country: United States
facility: Tri Cities Medical Research
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Dallas
country: United States
facility: Galenos Research
state: Texas
city: Fort Worth
country: United States
facility: Benchmark Research
state: Texas
city: Harker Heights
country: United States
facility: Team Research of Central Texas
state: Texas
city: Richardson
country: United States
facility: KRK Medical Research
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: San Antonio
country: United States
facility: Unlimited Research
state: Texas
city: San Antonio
country: United States
facility: Texas Medical Research Associates
state: Texas
city: Spring
country: United States
facility: Clinical Trial Network Oaks Medical Center
state: Texas
city: Wichita Falls
country: United States
facility: N. Texas Neuro Research
state: Texas
city: Salt Lake City
country: United States
facility: Lifetree Clinical Research
state: Utah
city: Oregon
country: United States
facility: Dean Medical Center
state: Wisconsin
Study officials:
affiliation: Purdue Pharma LP
name: Deborah L Steiner, MD, MS
role: STUDY_DIRECTOR
References: