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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN53366886

Enrollment

200

Registered

2005-07-26

Start date

1999-11-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the knee Musculoskeletal Diseases Osteoarthritis (OA)

Interventions

Topical diclofenac solution versus vehicle control solution.

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
Change from baseline to final assessment in stiffness, assessed using the WOMAC subscale	—

Countries

Canada

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 17, 2026