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The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain.

Primary Purpose

Back Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine transdermal delivery system
Sponsored by
Purdue Pharma LP
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Back Pain focused on measuring chronic back pain, opioid, transdermal

Eligibility Criteria

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

Inclusion Criteria: unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking </=2 short-acting opioid doses per day. taking >/=3 opioid doses per day with or without acceptable pain control. Exclusion Criteria: receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid. scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period. Other protocol-specific exclusion/inclusion criteria may apply.

Sites / Locations

  • Hawthorne & York, Intl, Ltd
  • Arizona Research & Education
  • Gainesville Clinical Research Center
  • Park Place Therapeutic Center
  • Atlanta Research Center
  • Rheumatology Associates, Inc.
  • Westside Family Medical Center
  • The Center for Pharmaceutical Research
  • The New York Hospital Cornell Medical Center
  • NC Clinical Research, Inc.
  • Pain Control Ctr Bowman Gray School of Med
  • Metroplex Clinical Research Center

Outcomes

Primary Outcome Measures

Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or if applicable, at early termination.

Secondary Outcome Measures

Brief Pain Inventory
dropouts due to lack of efficacy
MOS health survey
VAS pain intensity
therapeutic response
patient preference
daily patient diary
and number of oxycodone/acetaminophen or placebo tablets taken

Full Information

First Posted
April 18, 2006
Last Updated
May 13, 2013
Sponsor
Purdue Pharma LP
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1. Study Identification

Unique Protocol Identification Number
NCT00315874
Brief Title
The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain.
Official Title
Safety and Efficacy of Buprenorphine TDS (Transdermal Delivery System) 5, 10 and 20 Applied Every 7 Days for Sixty Days vs. 5 mg Oxycodone/325 mg Acetaminophen Tablets q6h Prn vs. Placebo in Patients With Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 1998 (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 demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (5, 10, and 20 mg) in comparison to placebo transdermal system and immediate release oxycodone/acetaminophen in subjects with chronic low back pain inadequately treated with non-opioid analgesics. The double-blind treatment intervention duration is 60 days.
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
Back Pain
Keywords
chronic back pain, opioid, transdermal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
225 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Buprenorphine transdermal delivery system
Primary Outcome Measure Information:
Title
Pain on average and pain right now scores at days 0, 9, 15, 30, 45, 60, or if applicable, at early termination.
Secondary Outcome Measure Information:
Title
Brief Pain Inventory
Title
dropouts due to lack of efficacy
Title
MOS health survey
Title
VAS pain intensity
Title
therapeutic response
Title
patient preference
Title
daily patient diary
Title
and number of oxycodone/acetaminophen or placebo tablets taken

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: unacceptable pain control despite currently taking a nonsteroidal anti-inflammatory drug considered at a therapeutic and/or tolerated dose or currently taking </=2 short-acting opioid doses per day. taking >/=3 opioid doses per day with or without acceptable pain control. Exclusion Criteria: receiving opioids at an average daily dose of greater than 60 mg of oral morphine equivalents or subjects receiving more than 6 tablets per day of a short-acting opioid. scheduled to have surgery (including dental) involving the use of post- or preoperative analgesics or anesthetics during the study period. Other protocol-specific exclusion/inclusion criteria may apply.
Facility Information:
Facility Name
Hawthorne & York, Intl, Ltd
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85008
Country
United States
Facility Name
Arizona Research & Education
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Gainesville Clinical Research Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Park Place Therapeutic Center
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Atlanta Research Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Rheumatology Associates, Inc.
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Westside Family Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
The Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
The New York Hospital Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
NC Clinical Research, Inc.
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Pain Control Ctr Bowman Gray School of Med
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Metroplex Clinical Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain.

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