MedTrace Logo

Preventing Gastric Glitch With Prucalopride and Buspirone: N-of-1 Clinical Trial

NCT05377619 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-05-17

No results posted yet for this study

Summary

Background: Gastric glitch is a new functional disease characterized by severe and transient epigastric pain occurring after challenges such as drinking alcohol and eating specific foods. Aims: In this N-of-1 trial, we first characterized the clinical and gastric tomographic images of a patient with gastric glitch highly reproducible after alcohol challenging, and then tested the effect of prucalopride and buspirone on the prevention of gastric glitch crises.

Conditions

  • Dyspepsia

Interventions

DRUG

Prucalopride

prucalopride 2 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner

DRUG

Buspirone

buspirone 10 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner

DRUG

Placebo

placebo 1 hour before the challenge with intake of wine (200 ml) and a dinner

Sponsors & Collaborators

  • Universidade de Passo Fundo

    lead OTHER

Principal Investigators

  • Fernando Fornari · University of Passo Fundo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-06
Primary Completion
2022-03-06
Completion
2022-03-06

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05377619 on ClinicalTrials.gov