Effectiveness of Diclofenac versus Paracetamol in primary care patients with knee osteoarthritis. - DIPA-trial

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004114-28-NL

Enrollment

154

Registered

2008-11-24

Start date

2009-04-01

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Knee Osteoarthritis MedDRA version: 9.1 Level: LLT Classification code 10023476 Term: Knee osteoarthritis

Interventions

Trade Name: Diclofenac Product Name: Diclofenacnatrium 50 PHC Product Code: RVG 11986 Pharmaceutical Form: Tablet INN or Proposed INN: DICLOFENAC CAS Number: 15307865 Concentration unit: mg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients consulting for a new episode with non-traumatic knee pain in the general practice. - Complying to the clinical American College of Rheumatology (ACR) criteria for osteoarthrosis of the knee. - Have an indication for pain medication. - A score of 3 or more on the pain severity scale (0-10 scale). - Patients’ aged 45 years or older. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Contra-indication for NSAID or Paracetamol use (these are: Gastrointestinal bleedings in history or active, blood dyscrasia, bone marrow depression, serious heart failure, serious liver or kidney disease (glomerular filtration < 30 ml/min), known alcoholism, Colitis Ulcerosa, Crown disease, sulphite hypersensitivity, appearance of asthma, urticaria, angioedema, nasal polyps or rhinitis after use of acetylsalicylic acid or other prostaglandin synthetase inhibitors, or use of anti-depressives (SSRIs). - An arthroplasty or osteotomy of the knee in contralateral or unilateral side. - Already taking NSAID or paracetamol medication of similar or higher doses as in the study. - Surgery or major trauma of the affected joint within the previous 6 months. - Pregnancy. - Use of corticosteroid of hyaluronic acid.

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective is to assess whether there is a clinically relevant effectiveness of Diclofenac compared to Paracetamol for a period of two weeks and if necessarily another two weeks (conform Dutch guidelines of the general practitioners) in new consulters with knee OA in the general practice;Secondary Objective: Secondary objectives are to identify possible predictors of a clinical relevant better effectiveness of Diclofenac compared to Paracetamol and when additional funding is obtained, to assess the cost-effectiveness. ;Primary end point(s): Pain and function measured with the Western Ontario and McMaster (WOMAC) Osteoarthritis Index.	—

Measure

Time frame

Main Objective: The primary objective is to assess whether there is a clinically relevant effectiveness of Diclofenac compared to Paracetamol for a period of two weeks and if necessarily another two weeks (conform Dutch guidelines of the general practitioners) in new consulters with knee OA in the general practice;Secondary Objective: Secondary objectives are to identify possible predictors of a clinical relevant better effectiveness of Diclofenac compared to Paracetamol and when additional funding is obtained, to assess the cost-effectiveness. ;Primary end point(s): Pain and function measured with the Western Ontario and McMaster (WOMAC) Osteoarthritis Index.

—

Countries

Netherlands

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026