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Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly
This study has been completed.
Sponsored by: Napp Pharmaceuticals Limited
Information provided by: Napp Pharmaceuticals Limited
ClinicalTrials.gov Identifier: NCT00324038
  Purpose

The primary objective is to compare buprenorphine transdermal delivery system (BTDS) with standard- treatment in subjects with osteoarthritis (OA).


Condition Intervention Phase
Osteoarthritis
 Drug: Buprenorphine Transdermal Delivery System
 Phase IV

MedlinePlus related topics: Osteoarthritis
Drug Information available for: Buprenorphine Buprenorphine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title: An Open, Randomised, Multicentre Study to Compare Buprenorphine Transdermal Delivery System (BTDS) With Standard Treatment in Elderly Subjects With OA of the Hip and/or Knee

Further study details as provided by Napp Pharmaceuticals Limited:

Primary Outcome Measures:
  • The primary efficacy measure will be the average daily pain score.

Secondary Outcome Measures:
  • Optimum method of titration
  • Escape medication use
  • Sleep scale
  • Laxative use

Estimated Enrollment: 200
Study Start Date: March 2006
Study Completion Date: December 2007
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Either sex aged 65 or above
  • Diagnosis of OA of the hip and/or knee
  • Severe pain requiring step two medication
  • Taking maximum dose of paracetamol

Exclusion Criteria:

  • Painful disease of the joints other than OA
  • Contraindication to buprenorphine, other opioids, patch adhesives or nonsteroidal anti-inflammatory agents (NSAIDS)
  • Subjects taking cyclooxygenase (COX) II selective inhibitors
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00324038

Locations
United Kingdom
Napp Pharmaceuticals Ltd
Cambridge, United Kingdom, CB4 0GW
Sponsors and Collaborators
Napp Pharmaceuticals Limited
Investigators
Principal Investigator: Prof Philip Conaghan Unaffiliated
  More Information

Study ID Numbers: 2005-004279-39, BUP4004
Study First Received: May 9, 2006
Last Updated: April 29, 2008
ClinicalTrials.gov Identifier: NCT00324038  
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Napp Pharmaceuticals Limited:
OA
Elderly
Pain
OA of the hips and/or knees

Study placed in the following topic categories:
Buprenorphine
Musculoskeletal Diseases
Osteoarthritis
Joint Diseases
 Arthritis
Pain
Rheumatic Diseases

Additional relevant MeSH terms:
Sensory System Agents
Therapeutic Uses
Narcotic Antagonists
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
 Peripheral Nervous System Agents
Analgesics
Central Nervous System Agents
Pharmacologic Actions
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009



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