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 |
| Secondary identifying numbers | RA-CP-109 |
- Submission date
- 25/07/2005
- Registration date
- 26/07/2005
- Last edited
- 11/04/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Philip Baer
Scientific
Scientific
Malvern Medical Centre
1333 Neilson Road
Toronto, Ontario
M1B 4Y9
Canada
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Diclofenac |
| Primary outcome measure | 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 study start date | 01/11/1999 |
| Completion date | 31/08/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 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 |
Locations
Countries of recruitment
- Canada
Study participating centre
Malvern Medical Centre
Toronto, Ontario
M1B 4Y9
Canada
M1B 4Y9
Canada
Sponsor information
Dimethaid Research Inc. (Canada)
Industry
Industry
1405 Denison Street
Markham, Ontario
L3R 5V2
Canada
| Website | http://www.dimethaid.com/ |
|---|---|
"ROR" |
https://ror.org/00qe6gb33 |
Funders
Funder type
Industry
Dimethaid Research Inc. (Canada)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 08/08/2005 | Yes | No |
