Effect of pre-operative pain treatment by means of duloxetine on postoperative outcome after total hip or knee arthroplasty - Duloxetine In OsteoArthritis study (DOA-study)

MCG0 sitesFebruary 24, 2014

Overview

No summary available.

Registry

who.int

Start Date

February 24, 2014

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

MCG

•1\.Primary Osteoarthritis (based on clinical and radiological ACR\-criteria)
•2\.Age \>18 years
•3\.A neuropathic or at least a mixed neuropathic / noiciceptive pain phenotype (m\-painDETECT\-score \>12\)
•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 49
•F.1\.3 Elderly (\>\=65 years) yes
•F.1\.3\.1 Number of subjects for this age range 70

•General exclusion criteria:
•1\.Surgical hip or knee joint procedures less than 1 year previously
•2\.Cognitive and/or neurological disorders that could interfere strongly with questionnaire surveys (e.g. Dementia)
•3\.Serious or unstable medical condition that could likely lead to hospitalization during the course of the study or compromise study participation.
•4\.Planned or intended to perform THA or TKA within the study duration (present planned arthroplasty not included)
•5\.A history of peripheral nerve injury
•6\.Previous exposure to Duloxetine
•Duloxetine related exclusion criteria:
•7\.Allergy to study medication or compounds of the Duloxetine capsule (or another SNRI);
•8\.History of peptic ulcer disease or bleeding disorder (or other substantial risk factor for bleeding)