Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RA-CP-109
Study information
Scientific title
Acronym
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Osteoarthritis of the knee
Intervention
Topical diclofenac solution versus vehicle control solution.
Intervention type
Drug
Phase
Not Specified
Drug names
Diclofenac
Primary outcome measures
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 measures
Change from baseline to final assessment in stiffness, assessed using the WOMAC subscale
Overall trial start date
01/11/1999
Overall trial end date
31/08/2000
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant 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
Recruitment start date
01/11/1999
Recruitment end date
31/08/2000
Locations
Countries of recruitment
Canada
Trial participating centre
Malvern Medical Centre
Toronto, Ontario
M1B 4Y9
Canada
Sponsor information
Organisation
Dimethaid Research Inc. (Canada)
Sponsor details
1405 Denison Street
Markham
Ontario
L3R 5V2
Canada
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Dimethaid Research Inc. (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results in http://www.ncbi.nlm.nih.gov/pubmed/16086839
Publication citations
-
Results
Baer PA, Thomas LM, Shainhouse Z, Treatment of osteoarthritis of the knee with a topical diclofenac solution: a randomised controlled, 6-week trial [ISRCTN53366886]., BMC Musculoskelet Disord, 2005, 6, 44, doi: 10.1186/1471-2474-6-44.