Skip to content

Duloxetine for chronic osteoarthritis pain; an important alternative?

Duloxetine for chronic osteoarthritis pain; an important alternative? - Duloxetine for chronic osteoarthritis pain

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON42274
Enrollment
362
Registered
2015-03-17
Start date
Unknown
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

Patients in the intervention group will be treated with duloxetine 1dd60mg and usual care during one year. The patients in the control group will be treated with usual care which consists of analges
Chronic pain
Duloxetine
General practice
Osteoarthritis

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

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, disturbed liverfunction, renal insufficiency (creatinine clearance

Design outcomes

Primary

MeasureTime frame
The primary outcome of this study will be pain at 3 months measured with the WOMAC pain subscale.

Secondary

MeasureTime frame
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).

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)