Placebo gecontroleerd onderzoek naar het effect van 6 maanden behandeling met doxycycline op pijn en functie in patiënten met artrose van de knie.
Recruiting
- Conditions
- 1. Knee osteoarthritis (knie artrose)<br />2. osteoarthritis (artrose).
- Registration Number
- NL-OMON26143
- Lead Sponsor
- Reumacentrum Sint Maartenskliniek Nijmegen
- Brief Summary
https://pubmed.ncbi.nlm.nih.gov/21551510/
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 230
Inclusion Criteria
1. Knee OA (index knee) according to the 1986 proposed ACR classification tree using clinical and radiological criteria (18): knee pain (VAS > 40mm during > 50% of last month), the presence of osteophytes and one of the following: age >50, crepitus, or morning stiffness < 30 minutes;
Exclusion Criteria
1. Other rheumatic diseases like rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematodes or psoriatic arthritis;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoint:<br /><br>Percentage of the patients achieving clinical response on pain and function, as defined by the OMERACT-OARSI set of responder criteria based on the KOOS dutch version - pain (sumscore question 5 to 9) and function sumscore question 1-17 – and VAS patient Global Assessment at week 24 compared between placebo and verum.
- Secondary Outcome Measures
Name Time Method Secondary endpoints: <br /><br>1. The use of analgesics (mean dose of paracetamol and NSAIDs, normalized for maximal registered dose);<br /><br>2. Quality of life measured using the SF-36;<br /><br>3. Safety (adverse events graded according to the CTC criteria).