Duloxetine for chronic osteoarthritis pain; an important alternative?
Phase 3
Withdrawn
- Conditions
- osteoarthritis10023213
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- Not specified
- Target Recruitment
- 362
Inclusion Criteria
1) having hip or knee OA based on the clinical ACR criteria, and 2) having chronic pain (most days of the last three months) in hip or knee, and 3) either: (i) a contra-indication for NSAIDs; (ii) adverse reactions of NSAIDs; or (iii) insufficient benefit of NSAIDs.
Exclusion Criteria
1) on waiting list for hip/knee replacement, and 2) use of antidepressants, 3) contra-indication of duloxetine (use of Monoamine Oxidase Inhibitors, having uncontrolled narrow-angle glaucoma, in combination with (other) central nervous system acting drugs, in combination with thioridazine, hypersensitivity to duloxetine, disturbed liverfunction, renal insufficiency (creatinine clearance <30)).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary outcome of this study will be pain at 3 months measured with the<br /><br>WOMAC pain subscale.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary outcomes will be pain at one year (WOMAC pain subscale), disability<br /><br>(WOMAC function subscale), adverse reactions, quality of life, compliance to<br /><br>treatment, patients*satisfaction, OARSI-OMERACT, co-interventions, costs (iMCQ,<br /><br>iPCQ).</p><br>