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Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

Primary Purpose

Back Pain Lower Back Chronic

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Buprenorphine
Oxycodone Immediate-Release
Sponsored by
Purdue Pharma LP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain Lower Back Chronic focused on measuring Low back pain, opioid, transdermal, Butrans

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: low back pain for 3 months or longer, confirmed by radiographic evidence. receiving a stable dose of an opioid analgesic for low back pain. Exclusion Criteria: taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment. requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain. Other protocol-specific exclusion/inclusion criteria may apply.

Sites / Locations

  • Birmingham Pain Center
  • Arthritis Clinical Intervention Program
  • Winston Physician Services, LLC
  • Arizona Research Center, Inc.
  • Radiant Research
  • Advanced Clinical Therapeutics
  • Hot Springs Pain Clinic
  • NuLife Clinical Research, Inc.
  • Lovelace Scientific Resources, Inc.
  • 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, Inc.
  • 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
  • Coastal Medical Research
  • 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
  • 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
  • Arthritis & 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 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

BTDS 5

BTDS 20

Oxycodone Immediate-Release

Arm Description

Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.

Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Outcomes

Primary Outcome Measures

Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.
Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)

Secondary Outcome Measures

Mean Daily Number of Supplemental Analgesic Tablets
The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase
Oswestry Disability Index (ODI) Score (V 2.0)
The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)
The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.
The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath). Question 1 is scored on a scale of 1 to 5 and Questions 3 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.

Full Information

First Posted
April 10, 2006
Last Updated
August 27, 2012
Sponsor
Purdue Pharma LP
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1. Study Identification

Unique Protocol Identification Number
NCT00313014
Brief Title
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain
Official Title
A Multicenter, Randomized, Double-blind, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-release Versus BTDS 5 in Subjects With Moderate to Severe Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Terminated
Why Stopped
Terminated early due to administrative reasons unrelated to efficacy or safety.
Study Start Date
February 2004 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
September 2005 (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 objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (BTDS) 20 in comparison to the buprenorphine transdermal system (BTDS) 5 and oxycodone immediate-release in subjects with moderate to severe low back pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen) 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 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, Butrans

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
660 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTDS 5
Arm Type
Active Comparator
Arm Description
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
Arm Title
BTDS 20
Arm Type
Experimental
Arm Description
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
Arm Title
Oxycodone Immediate-Release
Arm Type
Experimental
Arm Description
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
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
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Intervention Type
Drug
Intervention Name(s)
Oxycodone Immediate-Release
Intervention Description
Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
Primary Outcome Measure Information:
Title
Average Pain Over the Last 24 Hours Score at Weeks 4, 8, and 12.
Description
Subjects were evaluated during the double-blind phase for "average pain over the last 24 hours" prior to the study visits. Pain scale is 11 points (0 = no pain to 10 = pain as bad as you can imagine)
Time Frame
Last 24 hours score at weeks 4, 8, 12 of the double-blind phase
Secondary Outcome Measure Information:
Title
Mean Daily Number of Supplemental Analgesic Tablets
Description
The mean daily number of tablets of supplemental analgesic medications used during the double-blind phase
Time Frame
Double-blind phase (84 days)
Title
Oswestry Disability Index (ODI) Score (V 2.0)
Description
The ODI (version 2) is a low back pain-specific, validated instrument that consists of questions related to limitations in performing specific activities of daily living and 1 question related to pain intensity. The ODI is a self-administered questionnaire that is usually completed in less than 5 minutes. The ODI consists of 10 sections. Each section consists of 6 statements ranked from 0 to 5 (0 = good to 5 = worse). (Note: A higher score represents greater disability.)
Time Frame
Weeks 4, 8, 12
Title
The Sleep Disturbance Subscale in the MOS-Sleep Scale at Weeks 4, 8, and 12.
Description
The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity/ optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath). Question 1 is scored on a scale of 1 to 5 and Questions 3 to 12 are scored on a scale of 1 to 6. The Sleep Disturbance Subscale score is derived from the scores to Questions 1, 3, 7 and 8, and ranges from 0 to 100, where higher scores indicate greater sleep disturbance.
Time Frame
Weeks 4, 8, 12 of the double-blind phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: low back pain for 3 months or longer, confirmed by radiographic evidence. receiving a stable dose of an opioid analgesic for low back pain. Exclusion Criteria: taking more than 80 mg per day of oral morphine sulfate or equivalent within 30 days of enrollment. requiring frequent analgesic therapy for chronic condition(s), in addition to low back pain. Other protocol-specific exclusion/inclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Hale, MD
Organizational Affiliation
Gold Coast Research LLC, Weston, FL, USA
Official's Role
Principal Investigator
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, LLC
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
Tuscon
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, Inc.
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, Inc.
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
Coastal Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32168
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
11070
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
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
28860
Country
United States
Facility Name
Arthritis & 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

Citations:
PubMed Identifier
21807566
Citation
Steiner D, Munera C, Hale M, Ripa S, Landau C. Efficacy and safety of buprenorphine transdermal system (BTDS) for chronic moderate to severe low back pain: a randomized, double-blind study. J Pain. 2011 Nov;12(11):1163-73. doi: 10.1016/j.jpain.2011.06.003. Epub 2011 Jul 31.
Results Reference
result
Links:
URL
http://app.purduepharma.com/xmlpublishing/pi.aspx?id=b
Description
Product Information

Learn more about this trial

Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Low Back Pain

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