Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain - Full Text View

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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)
Genders Eligible for Study:	Both
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

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:

Product Information This link exits the ClinicalTrials.gov site


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
Health Authority:	United States: Food and Drug Administration

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 27, 2016