Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
Primary Purpose
Back Pain Lower Back Chronic
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine transdermal patch
Buprenorphine transdermal patch
Buprenorphine transdermal patch
Sponsored by
About this trial
This is an interventional treatment trial for Back Pain Lower Back Chronic focused on measuring Low back pain, Opioid, Transdermal
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.
Sites / Locations
- Birmingham Pain Center
- Arthritis Clinical Intervention Program
- Winston Physician Services, Inc
- Arizona Research Center Inc
- Radiant Research
- Advanced Clinical Therapeutics
- Hot Springs Pain Clinic
- NuLife Clinical Research, Inc.
- Lovelace Scientific Resources
- Northern California Research Corp
- International Clinical Research Network
- Shreenath Clinical Service
- U of Calif at Davis, Med Ctr, Pain Management Center
- Accelovance
- Southern Colorado Clinic
- Chiefland Medical Center
- University Clinical Research Deland
- Drug Study Institute
- Innovative Research of West Florida, Inc.
- Renstar Medical
- Peninsula Research Inc.
- The Arthritis Center
- University Clinical Research, Inc.
- Gold Coast Research, LLC
- Palm Beach Research Center
- Georgia Medical Research Institute
- Atlanta Knee & Shoulder Clinic
- Pain Care Boise
- Idaho Arthritis and Osteoporosis Center
- Pain and Rehabilitation Clinic of Chicago
- GFI Research Center
- MediSphere Medical Research Center, LLC
- Medical Associates Clinics
- Vince and Associates Clinical Research
- CTT, Inc.
- Commonwealth Biomedical Research, LLC
- New Orleans Clinical Trial Management Inc.
- Louisiana Research Associates, Inc.
- Best Clinical Trials, LLC
- Research Center of Louisiana
- Sinai Hospital of Baltimore
- Future Care Studies
- Rheumatology PC
- Lake Michigan Clinical Research & Consulting, Inc.
- Medex Healthcare Research Inc
- HealthCare Research
- Meridian Clinical Research, LLC
- Lovelace Scientific Resources
- Pivotal Research Centers
- Research Across America
- Pain and Orthopedic Neurology , Charlotte Spine Center,
- Metrolina Medical Research
- Triangle Orthopaedic Associates
- Pharmquest
- MedArk Clinical Research
- Wake Research Associates, LLC
- Center for Clinical Research
- Odyssey Research
- COR Clinical Research, LLC
- Associated Medical Services Inc
- Keystone Clinical Research
- Valley Pain Specialists
- Altoona Center for Clinical Research
- Central Pennsylvania Clinical Research
- BioMedical Research Associates
- University Orthopedics Center
- New England Center Clinical Research
- Omega Medical Research
- The Arthritis and Osteoporosis Center
- Brown Clinic
- Holston Medical Group
- Tri Cities Medical Research
- Holston Medical Group
- Galenos Research
- Benchmark Research
- Team Research of Central Texas
- KRK Medical Research
- Benchmark Research
- Unlimited Research
- Texas Medical Research Associates
- Clinical Trial Network Oaks Medical Center
- N. Texas Neuro Research
- Lifetree Clinical Research
- Dean Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
BTDS
Arm Description
Buprenorphine transdermal patch
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01125917
Brief Title
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
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Terminated early due to administrative reasons.
Study Start Date
June 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Purdue Pharma LP
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain Lower Back Chronic
Keywords
Low back pain, Opioid, Transdermal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
354 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BTDS
Arm Type
Experimental
Arm Description
Buprenorphine transdermal patch
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal patch
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal patch
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal patch
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Primary Outcome Measure Information:
Title
Number of Participants With Adverse Events (AEs) as a Measure of Safety
Description
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).
Time Frame
52-week extension phase
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah L Steiner, MD, MS
Organizational Affiliation
Purdue Pharma LP
Official's Role
Study Director
Facility Information:
Facility Name
Birmingham Pain Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35244
Country
United States
Facility Name
Arthritis Clinical Intervention Program
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Winston Physician Services, Inc
City
Haleyville
State/Province
Alabama
ZIP/Postal Code
35565
Country
United States
Facility Name
Arizona Research Center Inc
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Radiant Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85029
Country
United States
Facility Name
Advanced Clinical Therapeutics
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Hot Springs Pain Clinic
City
Hot Springs
State/Province
Arkansas
ZIP/Postal Code
71913
Country
United States
Facility Name
NuLife Clinical Research, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Lovelace Scientific Resources
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
Northern California Research Corp
City
Carmichael
State/Province
California
ZIP/Postal Code
95608
Country
United States
Facility Name
International Clinical Research Network
City
Chula Vista
State/Province
California
ZIP/Postal Code
91911
Country
United States
Facility Name
Shreenath Clinical Service
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
U of Calif at Davis, Med Ctr, Pain Management Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Accelovance
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Southern Colorado Clinic
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81008
Country
United States
Facility Name
Chiefland Medical Center
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
University Clinical Research Deland
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Drug Study Institute
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Innovative Research of West Florida, Inc.
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Renstar Medical
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Peninsula Research Inc.
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
The Arthritis Center
City
Palm Harbor
State/Province
Florida
ZIP/Postal Code
34684
Country
United States
Facility Name
University Clinical Research, Inc.
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Gold Coast Research, LLC
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Georgia Medical Research Institute
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Atlanta Knee & Shoulder Clinic
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
Pain Care Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Idaho Arthritis and Osteoporosis Center
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83742
Country
United States
Facility Name
Pain and Rehabilitation Clinic of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60610
Country
United States
Facility Name
GFI Research Center
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
MediSphere Medical Research Center, LLC
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Medical Associates Clinics
City
Dubuque
State/Province
Iowa
ZIP/Postal Code
52002
Country
United States
Facility Name
Vince and Associates Clinical Research
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
CTT, Inc.
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
Commonwealth Biomedical Research, LLC
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
New Orleans Clinical Trial Management Inc.
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Louisiana Research Associates, Inc.
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70114
Country
United States
Facility Name
Best Clinical Trials, LLC
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Research Center of Louisiana
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70115
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Future Care Studies
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
Rheumatology PC
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Lake Michigan Clinical Research & Consulting, Inc.
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Medex Healthcare Research Inc
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
HealthCare Research
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68134
Country
United States
Facility Name
Lovelace Scientific Resources
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89014
Country
United States
Facility Name
Pivotal Research Centers
City
North Las Vegas
State/Province
Nevada
ZIP/Postal Code
89030
Country
United States
Facility Name
Research Across America
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Facility Name
Pain and Orthopedic Neurology , Charlotte Spine Center,
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Metrolina Medical Research
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Triangle Orthopaedic Associates
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Pharmquest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
MedArk Clinical Research
City
Morgantown
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Wake Research Associates, LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Center for Clinical Research
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Odyssey Research
City
Bismark
State/Province
North Dakota
ZIP/Postal Code
58502
Country
United States
Facility Name
COR Clinical Research, LLC
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Associated Medical Services Inc
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Keystone Clinical Research
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Valley Pain Specialists
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18016
Country
United States
Facility Name
Altoona Center for Clinical Research
City
Duncansville
State/Province
Pennsylvania
ZIP/Postal Code
16635
Country
United States
Facility Name
Central Pennsylvania Clinical Research
City
Mechanicsburg
State/Province
Pennsylvania
ZIP/Postal Code
17055
Country
United States
Facility Name
BioMedical Research Associates
City
Shippensburg
State/Province
Pennsylvania
ZIP/Postal Code
17257
Country
United States
Facility Name
University Orthopedics Center
City
State College
State/Province
Pennsylvania
ZIP/Postal Code
16801
Country
United States
Facility Name
New England Center Clinical Research
City
Cranston
State/Province
Rhode Island
ZIP/Postal Code
29200
Country
United States
Facility Name
Omega Medical Research
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
The Arthritis and Osteoporosis Center
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Brown Clinic
City
Watertown
State/Province
South Dakota
ZIP/Postal Code
57201
Country
United States
Facility Name
Holston Medical Group
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Tri Cities Medical Research
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Galenos Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Benchmark Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
Team Research of Central Texas
City
Harker Heights
State/Province
Texas
ZIP/Postal Code
76548
Country
United States
Facility Name
KRK Medical Research
City
Richardson
State/Province
Texas
ZIP/Postal Code
75080
Country
United States
Facility Name
Benchmark Research
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
Unlimited Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Texas Medical Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
Country
United States
Facility Name
Clinical Trial Network Oaks Medical Center
City
Spring
State/Province
Texas
ZIP/Postal Code
77386
Country
United States
Facility Name
N. Texas Neuro Research
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76301
Country
United States
Facility Name
Lifetree Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Dean Medical Center
City
Oregon
State/Province
Wisconsin
ZIP/Postal Code
53575
Country
United States
12. IPD Sharing Statement
Links:
URL
http://app.purduepharma.com/xmlpublishing/pi.aspx?id=b
Description
Product Information
Learn more about this trial
Safety of BTDS in Subjects With Low Back Pain: A 52-Week Extension Phase of BUP3015
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