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Prucalopride and Buspirone for Gastric Glitch N-of-1 Trial
NCT05377619Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2022
- Primary completion
- Mar 2022
- Countries
- 1
- Sponsor
- Universidade de Passo Fundo
- Modality
- Small Molecules
- Conditions
- dyspepsia
01
Overview
Phase 2, randomised, double-blind trial in dyspepsia comparing Prucalopride, Buspirone and Placebo (3 arms). Primary endpoint: Pain severity during gastric glitch crises. Started Jan 2022; status: completed.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Prucalopride
Prucalopride 2 mg orally 1 hour before wine challenge (5 occasions).
Buspirone
Buspirone 10 mg orally 1 hour before wine challenge (5 occasions).
Placebo
Placebo orally 1 hour before wine challenge (5 occasions).
03
Who it enrols
Adult patient suffering from severe gastric pain after ingestion of a small amount of wine.
04
Endpoints
Primary
Pain severity during gastric glitch crises
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