|
ISRCTN
|
ISRCTN53366886
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
A double blinded, placebo-controlled, two-way parallel clinical trial to confirm the safety and efficacy of Pennsaid in the treatment of the osteoarthritic knee
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
RA-CP-109
|
|
Study hypothesis
|
To evaluate the efficacy and safety of a topical diclofenac solution compared with a vehicle control solution in the treatment of the symptoms of osteoarthritis of the knee.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Canada
|
|
Disease/condition/study domain
|
Osteoarthritis of the knee
|
|
Participants - inclusion criteria
|
1. Primary osteoarthritis of the knee characterised by deterioration and abrasion of articular cartilage and/or formation of new bone at the joint surface
2. Age between 40 and 85 years
3. Moderate flare of pain after discontinuation of prior non-steroidal anti-inflammatory drug (NSAID)/analgesic
4. Non-pregnant
|
|
Participants - exclusion criteria
|
1. Sensitivity to NSAIDs
2. Severe, uncontrolled systemic disease
3. Gastro-duodenal ulcer
4. Secondary osteoarthritis
5. Corticosteroid use
6. Prior intra-articular viscosupplementation
7. Fibromyalgia
|
|
Anticipated start date
|
01/11/1999
|
|
Anticipated end date
|
31/08/2000
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
200
|
|
Interventions
|
Topical diclofenac solution versus vehicle control solution.
|
|
Primary outcome measure(s)
|
Change from baseline to final assessment in pain and physical function, assessed using the Western Ontario McMaster Universities Osteoarthritis (WOMAC) subscales, and patient global assessment
|
|
Secondary outcome measure(s)
|
Change from baseline to final assessment in stiffness, assessed using the WOMAC subscale
|
|
Sources of funding
|
Dimethaid Research Inc. (Canada)
|
|
Trial website
|
|
|
Publications
|
Results in http://www.ncbi.nlm.nih.gov/pubmed/16086839
|
|
Contact name
|
Dr
Philip
Baer
|
|
Address
|
Malvern Medical Centre
1333 Neilson Road
|
|
City/town
|
Toronto, Ontario
|
|
Zip/Postcode
|
M1B 4Y9
|
|
Country
|
Canada
|
|
Sponsor
|
Dimethaid Research Inc. (Canada)
|
|
Address
|
1405 Denison Street
|
|
City/town
|
Markham, Ontario
|
|
Zip/Postcode
|
L3R 5V2
|
|
Country
|
Canada
|
|
Sponsor website:
|
http://www.dimethaid.com/
|
|
Date applied
|
25/07/2005
|
|
Last edited
|
11/04/2008
|
|
Date ISRCTN assigned
|
26/07/2005
|
