Duloxetine for chronic osteoarthritis pain; an important alternative?

Phase 3

Completed

• Conditions: osteoarthritis; 10023213

• Registration Number: NL-OMON47264
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 224

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

1) on waiting list for hip/knee replacement, and 2) use of antidepressants or 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 liverfunction, renal insufficiency (creatinine clearance < 30ml/min), usage of strong CYP1A2-inhibitors and CYP2D6-inhibitors and substrates).

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pain at three months measured with the WOMAC pain subscale.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pain at one year (WOMAC), disability (WOMAC), adverse reactions, quality of<br /><br>life, compliance to treatment, patients* satisfaction, OARSI-OMERACT,<br /><br>co-interventions and costs (iMCQ and iPCQ)</p><br>