Buprenorphine in the Treatment of Osteoarthritis (OA) in the Elderly

This study has been completed.
Sponsor:
Information provided by:
Napp Pharmaceuticals Limited
ClinicalTrials.gov Identifier:
NCT00324038
First received: May 9, 2006
Last updated: June 13, 2011
Last verified: June 2011
  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
Drug: Codeine paracetamol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Napp Pharmaceuticals Limited:

Primary Outcome Measures:
  • Average Daily Pain Scores - BS11 Pain Scores. [ Time Frame: every day over a 12 week study duration. ] [ Designated as safety issue: No ]
    The primary efficacy variable was the average daily pain score recorded on a Box Scale-11 pain scale in the evening. 0 = no pain and 10 = most pain imaginable. Subjects ticked the box from 0 - 10 which best describes their level of pain.


Enrollment: 219
Study Start Date: March 2006
Study Completion Date: December 2007
Arms Assigned Interventions
Experimental: buprenorphine transdermal system
Buprenorphine transdermal 7 day analgesic patch
Drug: Buprenorphine
buprenorphine transdermal system 5, 10 and 20 mg
Other Name: BuTrans/Norspan
Active Comparator: codeine paracetamol tablets
codeine paracetamol combination tablets
Drug: Codeine paracetamol
combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
Other Name: Co-codamol tablets

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
  More Information

No publications provided by Napp Pharmaceuticals Limited

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr J Paul Schofield, Napp Pharmaceuticals Ltd
ClinicalTrials.gov Identifier: NCT00324038     History of Changes
Other Study ID Numbers: 2005-004279-39, BUP4004
Study First Received: May 9, 2006
Results First Received: July 17, 2009
Last Updated: June 13, 2011
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

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Acetaminophen
Buprenorphine
Codeine
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Analgesics, Opioid
Central Nervous System Depressants
Narcotic Antagonists
Narcotics
Antitussive Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on July 24, 2014