Condition category
Musculoskeletal Diseases
Date applied
25/07/2005
Date assigned
26/07/2005
Last edited
11/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Philip Baer

ORCID ID

Contact details

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

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

http://www.dimethaid.com/

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

  1. 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.

Additional files

Editorial Notes