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Trial record 2 of 6 for:    napp pharmaceuticals

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00324038
First Posted: May 10, 2006
Last Update Posted: June 14, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Napp Pharmaceuticals Limited
  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
Intervention Model: Parallel Assignment
Masking: None (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. ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): 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

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
First Submitted: May 9, 2006
First Posted: May 10, 2006
Results First Submitted: July 17, 2009
Results First Posted: March 30, 2010
Last Update Posted: June 14, 2011
Last Verified: June 2011

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
Buprenorphine
Codeine
Acetaminophen
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Analgesics, Non-Narcotic
Antipyretics
Antitussive Agents
Respiratory System Agents