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

September 5, 2012 updated by: Purdue Pharma LP

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

418

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Parkway Medical Center
    • California
      • Chula Vista, California, United States, 91910
        • International Clinical Research Network
      • Roseville, California, United States, 95661
        • Clinical Trials Research
      • San Diego, California, United States, 92108
        • Accelovance
      • Torrance, California, United States, 90505
        • Torrance Clinical Research
    • Colorado
      • Pueblo, Colorado, United States, 81008
        • Southern Colorado Clinic
    • Florida
      • Jupiter, Florida, United States, 33458
        • Drug Study Institute
      • Largo, Florida, United States, 33770
        • Innovative Research of West Florida, Inc.
      • Ormond Beach, Florida, United States, 32174
        • Peninsula Research, Inc.
      • Ormond Beach, Florida, United States, 32174
        • International Medical Research
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research Center
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Georgia Medical Research Institute
      • Marietta, Georgia, United States, 30060
        • Non- Surgical Orthopedic & Spine Center, P.C.
    • Illinois
      • Springfield, Illinois, United States, 62704
        • The Arthritis Center
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Commonwealth Biomedical Research, LLC
    • Massachusetts
      • Brockton, Massachusetts, United States, 23010
        • Miray Medical Center
    • Michigan
      • Benzonia, Michigan, United States, 49616
        • Professional Clinical Research Crystal Lake Health Center
      • Kalamazoo, Michigan, United States, 49009
        • Rheumatology Pc
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Pharm Quest
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
    • Texas
      • Amarillo, Texas, United States, 79124
        • Amarillo Center for Clinical Research
      • Hurst, Texas, United States, 76054
        • Med Search Professional Group/Pharmaceutical C-Trials Inc.
      • San Antonio, Texas, United States, 78238
        • Texas Medical Research Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BTDS 5
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Drug: Buprenorphine
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Other Names:
  • Butrans™
Drug: Buprenorphine
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Other Names:
  • 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 Names:
  • Butrans™
Drug: Buprenorphine
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Other Names:
  • 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
"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).
Weeks 4, 8, and 12 of the double-blind phase

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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®.
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
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).
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
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.
Weeks 4, 8, and 12 of the Double-blind Phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Purdue Pharma LP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

July 1, 2005

Study Completion (Actual)

August 1, 2005

Study Registration Dates

First Submitted

April 6, 2006

First Submitted That Met QC Criteria

April 6, 2006

First Posted (Estimate)

April 7, 2006

Study Record Updates

Last Update Posted (Estimate)

September 10, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUP3019

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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