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EDULOX 2: Patient education and duloxetine versus active placebo for severe functional somatic disorder
2024-514264-42-00Phase 4Authorised
- Sponsor
- Central Denmark Region
- Start
- Feb 2024
- Modality
- Small Molecules
- Countries
- 1
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Overview
Phase 4, randomised, double-blind trial of duloxetine and benztropine in Functional Somatic Disorder (FSD) and bodily distress syndrome (BDS) (2 arms), sponsored by Central Denmark Region. Primary endpoints: SF-36 aggregate physical health-related quality of life and function score at week 12 and Patient-rated Clinical Global Improvement at week 12. Planned start Feb 2024; status: authorised.
02
Drugs
duloxetinebenztropine
03
Conditions
Functional Somatic Disorder (FSD)bodily distress syndrome (BDS)
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