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

Phase 3

Terminated

Conditions: Osteoarthritis

Interventions: Drug: Buprenorphine
Drug: oxycodone immediate-release

Registration Number: NCT00312221

Lead Sponsor: Purdue Pharma LP

Brief Summary: 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.

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.

Recruitment & Eligibility

Status: TERMINATED

Sex: All

Target Recruitment: 418

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BTDS 20	Buprenorphine	Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Oxycodone Immediate-Release (Oxy IR) 40 mg	oxycodone immediate-release	Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
BTDS 5	Buprenorphine	Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear

Primary Outcome Measures

Name	Time	Method
"Average Pain Over the Last 24 Hours" Scores at Weeks 4, 8, and 12 of the Double-blind Phase.	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

Name	Time	Method
The Mean Daily Number of Supplemental Analgesic Medication Tablets	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	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	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.

Trial Locations

Locations (23): Accelovance
🇺🇸
San Diego, California, United States
Southern Colorado Clinic
🇺🇸
Pueblo, Colorado, United States
Palm Beach Research Center
🇺🇸
West Palm Beach, Florida, United States
Non- Surgical Orthopedic & Spine Center, P.C.
🇺🇸
Marietta, Georgia, United States
Pharm Quest
🇺🇸
Greensboro, North Carolina, United States
Med Search Professional Group/Pharmaceutical C-Trials Inc.
🇺🇸
Hurst, Texas, United States
Drug Study Institute
🇺🇸
Jupiter, Florida, United States
Innovative Research of West Florida, Inc.
🇺🇸
Largo, Florida, United States
Rheumatology PC
🇺🇸
Kalamazoo, Michigan, United States
Miray Medical Center
🇺🇸
Brockton, Massachusetts, United States
Parkway Medical Center
🇺🇸
Birmingham, Alabama, United States
Georgia Medical Research Institute
🇺🇸
Marietta, Georgia, United States
Clinical Trials Research
🇺🇸
Roseville, California, United States
Torrance Clinical Research
🇺🇸
Torrance, California, United States
Commonwealth Biomedical Research, LLC
🇺🇸
Madisonville, Kentucky, United States
The Clinical Trial Center, LLC
🇺🇸
Jenkintown, Pennsylvania, United States
Texas Medical Research Associates
🇺🇸
San Antonio, Texas, United States
Amarillo Center for Clinical Research
🇺🇸
Amarillo, Texas, United States
International Clinical Research Network
🇺🇸
Chula Vista, California, United States
International Medical Research
🇺🇸
Ormond Beach, Florida, United States
The Arthritis Center
🇺🇸
Springfield, Illinois, United States
Professional Clinical Research Crystal Lake Health Center
🇺🇸
Benzonia, Michigan, United States
Peninsula Research, Inc.
🇺🇸
Ormond Beach, Florida, United States