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

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ClinicalTrials.gov Identifier: NCT00312221
Recruitment Status : Terminated (terminated early for administrative reasons unrelated to safety or efficacy)
First Posted : April 7, 2006
Results First Posted : September 15, 2010
Last Update Posted : September 10, 2012
Sponsor:
Information provided by (Responsible Party):
Purdue Pharma LP

Study Description
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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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Buprenorphine Drug: oxycodone immediate-release Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 418 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2004
Actual Primary Completion Date : July 2005
Actual Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arms and Interventions
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Arm Intervention/treatment
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).


Outcome Measures
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Primary Outcome Measures :
  1. "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 Outcome Measures :
  1. 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®.

  2. 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).


  3. 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.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00312221


Locations
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Sponsors and Collaborators
Purdue Pharma LP
More Information
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Additional Information:

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Responsible Party: Purdue Pharma LP
ClinicalTrials.gov Identifier: NCT00312221    
Other Study ID Numbers: BUP3019
First Posted: April 7, 2006    Key Record Dates
Results First Posted: September 15, 2010
Last Update Posted: September 10, 2012
Last Verified: September 2012
Keywords provided by Purdue Pharma LP:
Osteoarthritis, opioid, transdermal
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Oxycodone
Buprenorphine
Analgesics, Opioid
 Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists