Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015

Back Pain Lower Back Chronic Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01125917
• Other study ID #: BUP3015S
• Status: Terminated
• Phase: Phase 3
• First received: May 17, 2010
• Last updated: August 27, 2012
• Start date: June 2004
• Est. completion date: January 2008

Study information

• Verified date: August 2012
• Source: Purdue Pharma LP
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 354
• Est. completion date: January 2008
• Est. primary completion date: September 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Back Pain Lower Back Chronic
• Low Back Pain

Intervention

Drug:
• Buprenorphine transdermal patch
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
• Buprenorphine transdermal patch
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
• Buprenorphine transdermal patch
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Purdue Pharma LP

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs) as a Measure of Safety	The purpose of the extension phase was to evaluate the long-term safety and tolerability of BTDS in subjects who had participated in the core study (BUP3015).	52-week extension phase	Yes

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