Back to resultsThe Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine transdermal delivery system
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, opioid, transdermal
Eligibility Criteria
Inclusion Criteria: clinical evidence of chronic back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, osteoarthritis, or other, similar nonmalignant conditions. back pain treated with an opioid-containing analgesic at a dose equal to or less than the equivalent of 90 mg of oral morphine per day or 12 or fewer capsules or tablets of an opioid combination analgesic per day. Exclusion Criteria: receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets per day of short-acting opioid-containing products. scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics. Other protocol-specific exclusion/inclusion criteria may apply.
Sites / Locations
- Rheumatology Associates of North Alabama
- Arizona Research Center
- Arthritis Center of Connecticut
- University Clinical Research
- Gainesville Clinical Research Center
- Miami Research Associates
- Sarasota Arthritis Center
- Coastal Medical Research
- Palm Beach Research Center
- Private Practice
- Pain Management & Rehabilitation
- Mid-America Rheumatology Consultants
- Riverhills Healthcare
- Arthritis & Osteoporosis Treatment & Research Center
- Center for Pharmaceutical Research
- PrecisionMed, Inc.
- Cornerstone Research Care
- Consultants for Clinical Research
- Center for Clinical Research
- The Arthritis Clinic of Northern Virginia
- Evergreen Clinical Research
- Private Practice
Outcomes
Primary Outcome Measures
Patient Satisfaction With Medication for Pain and Average Pain Intensity scores on days 0, 7, 14, 21, 28, 35, 42, 49, 56 and, if applicable, at early termination.
Secondary Outcome Measures
Average Pain Intensity and Patient Satisfaction With Medication for Pain scores (Patient Global Efficacy Rating)
incidence of and time to early discontinuation due to lack of efficacy
investigator's assessment of therapeutic response
dose level at the end of titration
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00315887
Brief Title
The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.
Official Title
A Double-Blind Comparative Study of Buprenorphine Transdermal System (BTDS) and Hydrocodone/Acetaminophen Tablets in Patients With Chronic Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 1999 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Purdue Pharma LP
4. Oversight
5. Study Description
Brief Summary
The objective of this study is to assess the safety and efficacy of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and hydrocodone/acetaminophen in subjects with chronic back pain. The double-blind treatment intervention duration is 56 days during which time supplemental analgesic medication (ibuprofen) will be provided to all subjects in addition to study drug.
Detailed Description
Buprenorphine is a synthetic opioid analgesic with over twenty-five 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. Transdermal systems may offer advantages over currently indicated oral products including ease and convenience of use, improved compliance, possible reduction in patient care, and prolonged and consistent delivery of drug.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
low back pain, opioid, transdermal
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
250 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal delivery system
Primary Outcome Measure Information:
Title
Patient Satisfaction With Medication for Pain and Average Pain Intensity scores on days 0, 7, 14, 21, 28, 35, 42, 49, 56 and, if applicable, at early termination.
Secondary Outcome Measure Information:
Title
Average Pain Intensity and Patient Satisfaction With Medication for Pain scores (Patient Global Efficacy Rating)
Title
incidence of and time to early discontinuation due to lack of efficacy
Title
investigator's assessment of therapeutic response
Title
dose level at the end of titration
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical evidence of chronic back pain related to intervertebral disc disease, nerve root entrapment, spondylolithesis, osteoarthritis, or other, similar nonmalignant conditions.
back pain treated with an opioid-containing analgesic at a dose equal to or less than the equivalent of 90 mg of oral morphine per day or 12 or fewer capsules or tablets of an opioid combination analgesic per day.
Exclusion Criteria:
receiving opioids at an average daily dose of greater than 90 mg of oral morphine equivalents or patients receiving more than 12 tablets per day of short-acting opioid-containing products.
scheduled to have surgery (including dental) during the study period that involved the use of pre- and/or postoperative analgesics or anesthetics.
Other protocol-specific exclusion/inclusion criteria may apply.
Facility Information:
Facility Name
Rheumatology Associates of North Alabama
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Arizona Research Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85023
Country
United States
Facility Name
Arthritis Center of Connecticut
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
University Clinical Research
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Gainesville Clinical Research Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Miami Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Sarasota Arthritis Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Coastal Medical Research
City
South Daytona Beach
State/Province
Florida
ZIP/Postal Code
32119
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
Private Practice
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Pain Management & Rehabilitation
City
Terre Haute
State/Province
Indiana
ZIP/Postal Code
47807
Country
United States
Facility Name
Mid-America Rheumatology Consultants
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66209
Country
United States
Facility Name
Riverhills Healthcare
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Arthritis & Osteoporosis Treatment & Research Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
PrecisionMed, Inc.
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Cornerstone Research Care
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Center for Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78758
Country
United States
Facility Name
The Arthritis Clinic of Northern Virginia
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22206
Country
United States
Facility Name
Evergreen Clinical Research
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Private Practice
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
12. IPD Sharing Statement
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The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Back Pain.
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