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

ISRCTN	ISRCTN53366886
DOI	https://doi.org/10.1186/ISRCTN53366886
Protocol serial number	RA-CP-109
Sponsor	Dimethaid Research Inc. (Canada)
Funder	Dimethaid Research Inc. (Canada)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Philip Baer
Scientific

Malvern Medical Centre
1333 Neilson Road
Toronto, Ontario
M1B 4Y9
Canada

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Osteoarthritis of the knee
Intervention	Topical diclofenac solution versus vehicle control solution.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Diclofenac
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
Key secondary outcome measure(s)	Change from baseline to final assessment in stiffness, assessed using the WOMAC subscale
Completion date	31/08/2000

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	01/11/1999
Date of final enrolment	31/08/2000

Malvern Medical Centre

Toronto, Ontario
M1B 4Y9
Canada

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	08/08/2005		Yes	No