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

Primary Purpose

Osteoarthritis

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Buprenorphine
Buprenorphine
oxycodone immediate-release
Sponsored by
Purdue Pharma LP
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis focused on measuring Osteoarthritis, opioid, transdermal

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Parkway Medical Center
  • International Clinical Research Network
  • Clinical Trials Research
  • Accelovance
  • Torrance Clinical Research
  • Southern Colorado Clinic
  • Drug Study Institute
  • Innovative Research of West Florida, Inc.
  • International Medical Research
  • Peninsula Research, Inc.
  • Palm Beach Research Center
  • Georgia Medical Research Institute
  • Non- Surgical Orthopedic & Spine Center, P.C.
  • The Arthritis Center
  • Commonwealth Biomedical Research, LLC
  • Miray Medical Center
  • Professional Clinical Research Crystal Lake Health Center
  • Rheumatology PC
  • Pharm Quest
  • The Clinical Trial Center, LLC
  • Amarillo Center for Clinical Research
  • Med Search Professional Group/Pharmaceutical C-Trials Inc.
  • Texas Medical Research Associates

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

BTDS 5

BTDS 20

Oxycodone Immediate-Release (Oxy IR) 40 mg

Arm Description

Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear

Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear

Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).

Outcomes

Primary Outcome Measures

"Average Pain Over the Last 24 Hours" Scores at 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
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
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
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.

Full Information

First Posted
April 6, 2006
Last Updated
September 5, 2012
Sponsor
Purdue Pharma LP
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1. Study Identification

Unique Protocol Identification Number
NCT00312221
Brief Title
Safety and Efficacy of Buprenorphine Transdermal System (BTDS) in Subjects With Moderate to Severe Osteoarthritis Pain
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Terminated
Why Stopped
terminated early for administrative reasons unrelated to safety or efficacy
Study Start Date
April 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Purdue Pharma LP

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
Osteoarthritis, opioid, transdermal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
418 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BTDS 5
Arm Type
Active Comparator
Arm Description
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Arm Title
BTDS 20
Arm Type
Experimental
Arm Description
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Arm Title
Oxycodone Immediate-Release (Oxy IR) 40 mg
Arm Type
Experimental
Arm Description
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
Intervention Type
Drug
Intervention Name(s)
Buprenorphine
Other Intervention Name(s)
Butrans™
Intervention Description
Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
Intervention Type
Drug
Intervention Name(s)
oxycodone immediate-release
Intervention Description
Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
Primary Outcome Measure Information:
Title
"Average Pain Over the Last 24 Hours" Scores at Weeks 4, 8, and 12 of the Double-blind Phase.
Description
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).
Time Frame
Weeks 4, 8, and 12 of the double-blind phase
Secondary Outcome Measure Information:
Title
The Mean Daily Number of Supplemental Analgesic Medication Tablets
Description
The mean daily number of supplemental analgesic medication tablets included sponsor-supplied ibuprofen, acetaminophen, or OxyIR®.
Time Frame
Double-blind phase (84 days)
Title
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
Description
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).
Time Frame
Weeks 4, 8 and 12 of the double-blind phase
Title
The Sleep Disturbance Subscale in The Medical Outcomes (MOS)-Sleep Scale at Weeks 4, 8, and 12 of the Double-blind Phase
Description
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.
Time Frame
Weeks 4, 8, and 12 of the Double-blind Phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Parkway Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
International Clinical Research Network
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Clinical Trials Research
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
Accelovance
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Torrance Clinical Research
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
Southern Colorado Clinic
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81008
Country
United States
Facility Name
Drug Study Institute
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Innovative Research of West Florida, Inc.
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
International Medical Research
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Peninsula Research, Inc.
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Facility Name
Palm Beach Research Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Georgia Medical Research Institute
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Non- Surgical Orthopedic & Spine Center, P.C.
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
The Arthritis Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Commonwealth Biomedical Research, LLC
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Miray Medical Center
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
23010
Country
United States
Facility Name
Professional Clinical Research Crystal Lake Health Center
City
Benzonia
State/Province
Michigan
ZIP/Postal Code
49616
Country
United States
Facility Name
Rheumatology PC
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Pharm Quest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
Amarillo Center for Clinical Research
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79124
Country
United States
Facility Name
Med Search Professional Group/Pharmaceutical C-Trials Inc.
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Texas Medical Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
Country
United States

12. IPD Sharing Statement

Links:
URL
http://app.purduepharma.com/xmlpublishing/pi.aspx?id=b
Description
Product Information

Learn more about this trial

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

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