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Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain
This study has been terminated.
(terminated early for administrative reasons unrelated to safety or efficacy)
Sponsor:
Purdue Pharma LP
Information provided by (Responsible Party):
Purdue Pharma LP
ClinicalTrials.gov Identifier:
NCT00312221
First received: April 6, 2006
Last updated: September 5, 2012
Last verified: September 2012
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Purpose
The objective of this study is to demonstrate the effectiveness and tolerability of the buprenorphine transdermal system (20 mg) in comparison to the buprenorphine transdermal system (5 mg) and oxycodone immediate release in subjects with moderate to severe osteoarthritis pain currently treated with oral opioids. The double-blind treatment intervention duration is 12 weeks during which time supplemental analgesic medication (acetaminophen, ibuprofen, immediate release oxycodone) will be provided to all subjects in addition to study drug.
| Condition | Intervention | Phase |
|---|---|---|
| Osteoarthritis | Drug: Buprenorphine Drug: oxycodone immediate-release | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Randomized, Double-blind, Multicenter Study to Determine the Efficacy and Safety of BTDS 20 or Oxycodone Immediate-Release (OxyIR) Versus BTDS 5 in Subjects With Moderate to Severe Osteoarthritis (OA) Pain |
Resource links provided by NLM:
MedlinePlus related topics:
Osteoarthritis
Drug Information available for:
Oxycodone
Oxycodone hydrochloride
Buprenorphine
Buprenorphine hydrochloride
U.S. FDA Resources
Further study details as provided by Purdue Pharma LP:
Primary Outcome Measures:
- "Average Pain Over the Last 24 Hours" Scores at Weeks 4, 8, and 12 of the Double-blind Phase. [ Time Frame: Weeks 4, 8, and 12 of the double-blind phase ]The "average pain over the last 24 hours" score was collected using an 11-point numerical scale ranging from 0 to 10, where 0 = no pain and 10 = pain as bad as you can imagine. This variable was obtained at each clinic visit during the double-blind phase of the study (postrandomization weeks 1, 2, 4, 8, and 12).
Secondary Outcome Measures:
- The Mean Daily Number of Supplemental Analgesic Medication Tablets [ Time Frame: Double-blind phase (84 days) ]The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®.
- The Physical Function Subscale of The Western Ontario and McMaster's Universities Osteoarthritis (WOMAC OA) Index at Weeks 4, 8, and 12 of the Double Blind Phase [ Time Frame: Weeks 4, 8 and 12 of the double-blind phase ]
The WOMAC (Version LK 3.1) measures symptoms and physical functioning of patients with OA of the hip and knee. It contains 24 items (5 pain, 2 stiffness, 17 physical function) and takes less than 5 minutes to complete.
The WOMAC physical function subscale has 17 items coded as 0 to 4 (best to worst), which are summed, giving a range of 0 to 68 (best to worst).
- The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase [ Time Frame: Weeks 4, 8, and 12 of the Double-blind Phase ]The MOS-Sleep Scale consists of 12 individual items: (4 sleep disturbance, 2 sleep adequacy, 1 quantity of optimal sleep, 3 somnolence, 1 snoring, and 1 shortness of breath) and takes 5 to 10 minutes to complete. Question 1 is scored on a scale of 1 to 5 and Questions 2 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.
| Enrollment: | 418 |
| Study Start Date: | April 2004 |
| Study Completion Date: | August 2005 |
| Primary Completion Date: | July 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: BTDS 5
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
|
Drug: Buprenorphine
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Other Name: Butrans™
|
|
Experimental: BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
|
Drug: Buprenorphine
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Other Name: Butrans™
|
|
Experimental: Oxycodone Immediate-Release (Oxy IR) 40 mg
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
|
Drug: oxycodone immediate-release
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
|
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.
Eligibility| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Osteoarthritis of the hip, knee, or spine for 1 year or longer, confirmed by radiographic evidence within the last 2 years.
- Good pain control while on a stable dose of an opioid analgesic for osteoarthritis.
Exclusion Criteria:
- Not currently taking and tolerating opioids.
- 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 osteoarthritis.
Other protocol-specific exclusion/inclusion criteria may apply.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312221
Please refer to this study by its ClinicalTrials.gov identifier: NCT00312221
Locations
| United States, Alabama | |
| Parkway Medical Center | |
| Birmingham, Alabama, United States, 35215 | |
| United States, California | |
| International Clinical Research Network | |
| Chula Vista, California, United States, 91910 | |
| Clinical Trials Research | |
| Roseville, California, United States, 95661 | |
| Accelovance | |
| San Diego, California, United States, 92108 | |
| Torrance Clinical Research | |
| Torrance, California, United States, 90505 | |
| United States, Colorado | |
| Southern Colorado Clinic | |
| Pueblo, Colorado, United States, 81008 | |
| United States, Florida | |
| Drug Study Institute | |
| Jupiter, Florida, United States, 33458 | |
| Innovative Research of West Florida, Inc. | |
| Largo, Florida, United States, 33770 | |
| International Medical Research | |
| Ormond Beach, Florida, United States, 32174 | |
| Peninsula Research, Inc. | |
| Ormond Beach, Florida, United States, 32174 | |
| Palm Beach Research Center | |
| West Palm Beach, Florida, United States, 33409 | |
| United States, Georgia | |
| Georgia Medical Research Institute | |
| Marietta, Georgia, United States, 30060 | |
| Non- Surgical Orthopedic & Spine Center, P.C. | |
| Marietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| The Arthritis Center | |
| Springfield, Illinois, United States, 62704 | |
| United States, Kentucky | |
| Commonwealth Biomedical Research, LLC | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Massachusetts | |
| Miray Medical Center | |
| Brockton, Massachusetts, United States, 23010 | |
| United States, Michigan | |
| Professional Clinical Research Crystal Lake Health Center | |
| Benzonia, Michigan, United States, 49616 | |
| Rheumatology PC | |
| Kalamazoo, Michigan, United States, 49009 | |
| United States, North Carolina | |
| Pharm Quest | |
| Greensboro, North Carolina, United States, 27401 | |
| United States, Pennsylvania | |
| The Clinical Trial Center, LLC | |
| Jenkintown, Pennsylvania, United States, 19046 | |
| United States, Texas | |
| Amarillo Center for Clinical Research | |
| Amarillo, Texas, United States, 79124 | |
| Med Search Professional Group/Pharmaceutical C-Trials Inc. | |
| Hurst, Texas, United States, 76054 | |
| Texas Medical Research Associates | |
| San Antonio, Texas, United States, 78238 | |
Sponsors and Collaborators
Purdue Pharma LP
More Information
Additional Information:
| Responsible Party: | Purdue Pharma LP |
| ClinicalTrials.gov Identifier: | NCT00312221 History of Changes |
| Other Study ID Numbers: |
BUP3019 |
| Study First Received: | April 6, 2006 |
| Results First Received: | July 15, 2010 |
| Last Updated: | September 5, 2012 |
Keywords provided by Purdue Pharma LP:
|
Osteoarthritis, opioid, transdermal |
Additional relevant MeSH terms:
|
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Buprenorphine Oxycodone Analgesics, Opioid |
Narcotics Central Nervous System Depressants Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Narcotic Antagonists |
ClinicalTrials.gov processed this record on September 21, 2017