The Safety and Efficacy of the Buprenorphine Transdermal Delivery System in Subjects With Chronic Low Back Pain.
This study has been completed.
Sponsor:
Purdue Pharma LP
Information provided by:
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00315874
First received: April 18, 2006
Last updated: May 13, 2013
Last verified: May 2013
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Back Pain |
Drug: Buprenorphine transdermal delivery system |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
Resource links provided by NLM:
Further study details as provided by Purdue Pharma LP:
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
| Estimated Enrollment: | 225 |
| Study Start Date: | April 1997 |
| Estimated Study Completion Date: | January 1998 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00315874
Locations
| United States, Arizona | |
| Arizona Research & Education | |
| Phoenix, Arizona, United States, 85012 | |
| Hawthorne & York, Intl, Ltd | |
| Phoenix, Arizona, United States, 85008 | |
| 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
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00315874 History of Changes |
| Other Study ID Numbers: | BP96-0102 |
| Study First Received: | April 18, 2006 |
| Last Updated: | May 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Purdue Pharma LP:
|
chronic back pain opioid transdermal |
Additional relevant MeSH terms:
|
Back Pain Low Back Pain Pain Neurologic Manifestations Nervous System Diseases Signs and Symptoms Buprenorphine Analgesics, Opioid Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Narcotic Antagonists Narcotics |
ClinicalTrials.gov processed this record on June 17, 2013