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Duloxetine for chronic osteoarthritis pain; an important alternative?


- candidate number19506
- NTR NumberNTR4798
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-sep-2014
- Secondary IDs80-83600-98-3143 ZonMw
- Public TitleDuloxetine for chronic osteoarthritis pain; an important alternative?
- Scientific TitleDuloxetine for chronic osteoarthritis pain; an important alternative?
- ACRONYM
- hypothesisDuloxetine is effective as third choice pain medication for treating chronic pain in osteoarthritis patients.
- Healt Condition(s) or Problem(s) studiedOsteoarthritis, Hip, Knee, Chronic pain, General practitioner
- Inclusion criteria1) 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 criteria1) 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)
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2015
- planned closingdate
- Target number of participants362
- InterventionsParticipating general practices will be randomized to either: 1) prescribe duloxetine as third choice pain medication in combination with usual care; or 2) provide usual care only (no antidepressants for pain medication).
- Primary outcomePain at 3 months measured with the WOMAC pain subscale
- Secondary outcomePain at 1 year (WOMAC pain subscale), Disability (WOMAC function subscale)
Adverse reactions
Quality of life with the EQ-5D
Compliance to treatment (Brief Medication Questionnaire)
Patientsí satisfaction
OARSI-OMERACT responder criteria
Costs; including direct medical and patient costs (iMCQ) and productivity costs (iPCQ).
- TimepointsBaseline, 3, 6, 9 and 12 months
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESDr. D. Schiphof
- CONTACT for SCIENTIFIC QUERIESDr. D. Schiphof
- Sponsor/Initiator Erasmus Medical Center, ZonMw: The Netherlands Organization for Health Research and Development
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD18-sep-2014 - 16-sep-2016


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl