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

NCT05377619 | Completed Phase 1

• 1 other identifier: 5.151.164
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain severity during gastric glitch crises

  Pain severity scored by the patient using a Likert scale (1 = minimal / 10 = maximal pain) following wine intake (200 ml)

  2 hours after challenging with wine intake

Other Outcomes (1)

• Occurrence of side effects secondary to tested drugs

  12 hours after drugs intake

Study Arms (3)

prucalopride

EXPERIMENTAL

prucalopride 2 mg 1 capsule orally 1 hour before the wine challenging (during a dinner), in five dinners (2 dinners per week)

Drug: Prucalopride

buspirone

EXPERIMENTAL

buspirone 10 mg 1 capsule orally 1 hour before the wine challenging (during a dinner), in five dinners (2 dinners per week)

Drug: Buspirone

placebo

PLACEBO COMPARATOR

placebo 1 capsule orally 1 hour before the wine challenging (during a dinner), in five dinners (2 dinners per week)

Drug: Placebo

Interventions

Prucalopride DRUG

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

Also known as: Resolor

prucalopride

Buspirone DRUG

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

Also known as: Ansitec

buspirone

Placebo DRUG

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

placebo

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patient suffering from severe gastric pain after ingestion of a small amount of wine

You may not qualify if:

• N/A (N-of-1 trial)

Sponsors & Collaborators

• Universidade de Passo Fundo: lead

Study Sites (1)

University of Passo Fundo

Passo Fundo, Rio Grande do Sul, 99010-080, Brazil

Location

MeSH Terms

Conditions

Dyspepsia

Interventions

prucalopride; Buspirone

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spiro Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Polycyclic Compounds

Study Officials

• Fernando Fornari

  University of Passo Fundo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Identical capsules containing prucalopride, buspirone or placebo.
• Purpose: PREVENTION
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: N-of-1 trial testing the effect of prucalopride, buspirone and placebo on the prevention of alcohol-induced gastric glitch

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 17, 2022
• Study Start: January 6, 2022
• Primary Completion: March 6, 2022
• Study Completion: March 6, 2022
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)