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
Overview
- Phase
- Phase 3
- Intervention
- Buprenorphine
- Conditions
- Osteoarthritis
- Sponsor
- Purdue Pharma LP
- Enrollment
- 418
- Locations
- 23
- Primary Endpoint
- "Average Pain Over the Last 24 Hours" Scores at Weeks 4, 8, and 12 of the Double-blind Phase.
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
BTDS 5
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Intervention: Buprenorphine
BTDS 20
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Intervention: Buprenorphine
Oxycodone Immediate-Release (Oxy IR) 40 mg
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Intervention: oxycodone immediate-release
Outcomes
Primary Outcomes
"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 Outcomes
- The Mean Daily Number of Supplemental Analgesic Medication Tablets(Double-blind phase (84 days))
- 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 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)