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Duloxetine for chronic osteoarthritis pain; an important alternative?

Duloxetine for chronic osteoarthritis pain; an important alternative?

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26725
Enrollment
362
Registered
2014-09-18
Start date
2015-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoarthritis

Interventions

Participating 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).

Sponsors

Erasmus MC ZonMw
Lead Sponsor

Eligibility

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.

Exclusion criteria

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)

Design outcomes

Primary

MeasureTime frame
Pain at 3 months measured with the WOMAC pain subscale

Secondary

MeasureTime frame
Pain 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) Patients’ satisfaction OARSI-OMERACT responder criteria Costs; including direct medical and patient costs (iMCQ) and productivity costs (iPCQ).

Contacts

Public ContactD. Schiphof

Erasmus MC, kamer NA1906 Postbus 2040

d.schiphof@erasmusmc.nl0031107043623

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)