osteoarthritis
Conditions
Interventions
Trade Name: Duloxetine
Pharmaceutical Form: Capsule, hard
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Netherlands
Contacts
Public ContactDepartment of General Practice
Erasmus MC
Outcome results
None listed