Duloxetine for chronic osteoarthritis pain; an important alternative?
- Conditions
- osteoarthritisTherapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
- Registration Number
- EUCTR2015-001669-16-NL
- Lead Sponsor
- Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 224
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.
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 112
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 112
1) on waiting list for hip/knee replacement, and 2) use of antidepressants and neuropathic pain medication 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 liver function, renal insufficiency (creatinine clearance <30 ml/min), usage of strong CYP1A2-inhibitors and CYP2D6-inhibitors and substrates)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The objective of this proposal is to investigate if duloxetine is effective as a third choice pain medication for treating chronic pain in OA compared to usual care;Secondary Objective: Furthermore, we will assess the cost-effectiveness of duloxetine treatment and if the presence of a neuropathic pain component favorably modifies the response to treatment and if the presence of a neuropathic component will be necessary for (cost-)effectiveness.;Primary end point(s): The primary outcome of this study will be pain at 3 months measured with the WOMAC pain subscale.;Timepoint(s) of evaluation of this end point: three months
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary outcomes will be pain at one year (WOMAC pain subscale), disability (WOMAC function subscale), adverse reactions, quality of life, compliance to treatment, patients' satisfaction, OARSI-OMERACT, co-interventions, costs (iMCQ, iPCQ);Timepoint(s) of evaluation of this end point: 1 year