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

• Conditions: Knee Osteoarthritis; MedDRA version: 9.1Level: LLTClassification code 10023476Term: Knee osteoarthritis

• Registration Number: EUCTR2008-004114-28-NL
• Lead Sponsor: Erasmus Medical Center; Department of general practice

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 154

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

- 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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.