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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00315874
Recruitment Status : Completed
First Posted : April 19, 2006
Last Update Posted : May 14, 2013
Information provided by:
Purdue Pharma LP

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.

Condition or disease Intervention/treatment Phase
Back Pain Drug: Buprenorphine transdermal delivery system Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
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 Start Date : April 1997
Estimated Study Completion Date : January 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain
U.S. FDA Resources

Primary Outcome Measures :
  1. 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 :
  1. Brief Pain Inventory
  2. dropouts due to lack of efficacy
  3. MOS health survey
  4. VAS pain intensity
  5. therapeutic response
  6. patient preference
  7. daily patient diary
  8. and number of oxycodone/acetaminophen or placebo tablets taken

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00315874

United States, Arizona
Hawthorne & York, Intl, Ltd
Phoenix, Arizona, United States, 85008
Arizona Research & Education
Phoenix, Arizona, United States, 85012
United States, Florida
Gainesville Clinical Research Center
Gainesville, Florida, United States, 32605
Park Place Therapeutic Center
Plantation, Florida, United States, 33324
United States, Georgia
Atlanta Research Center
Atlanta, Georgia, United States, 30033
United States, Indiana
Rheumatology Associates, Inc.
Indianapolis, Indiana, United States, 46260
United States, Michigan
Westside Family Medical Center
Kalamazoo, Michigan, United States, 49009
United States, Missouri
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
United States, New York
The New York Hospital Cornell Medical Center
New York, New York, United States, 10021
United States, North Carolina
NC Clinical Research, Inc.
Raleigh, North Carolina, United States, 27607
Pain Control Ctr Bowman Gray School of Med
Winston-Salem, North Carolina, United States, 27103
United States, Texas
Metroplex Clinical Research Center
Dallas, Texas, United States, 75235
Sponsors and Collaborators
Purdue Pharma LP Identifier: NCT00315874     History of Changes
Other Study ID Numbers: BP96-0102
First Posted: April 19, 2006    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013

Keywords provided by Purdue Pharma LP:
chronic back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists