A Phase 1/2 interventional study of Prucalopride and Buspirone in Dyspepsia, sponsored by Universidade de Passo Fundo. Completed at 1 site in Brazil. Open to female participants. Per ClinicalTrials.gov, last updated 2022-05-17.
Sponsored by Universidade de Passo Fundo · Phase 1/2, Interventional, and Prevention
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.
Objective: To evaluate the effect of prucalopride and buspirone, compared to placebo, in the prevention of gastric pain crises, in a double-blind clinical trial of a single patient. Methods: Female, 35 years old, with signed consent to participate in the study, received 15 capsules to take 1 capsule 60 minutes before ingesting 200 ml of red wine at home (≈20 grams of alcohol), twice a week, according to her routine food, totaling 15 meals. Thus, the experimental phase lasted about eight weeks. The 15 capsules contain placebo (5 capsules), prucalopride 2 mg (5 capsules) or buspirone 10 mg (5 capsules), prepared by a specialized pharmacy in such a way that their physical characteristics do not allow the identification of which agent is being administered, neither by the patient nor the investigator controlling the trial (double-blind). The aforementioned pharmacy generated a code for each pill, randomly, and provided a sealed list with the 15 codes and their respective drugs, for disclosure after the end of the study. The patient was instructed to record in a standardized diary the occurrence of pain crises after the wine challenge, as well as their duration and intensity (Likert 0 to 10: maximum pain), and accompanying symptoms. The patient was asked to contact the researchers directly (WhatsApp) throughout the trial, to clarify any doubts or need for some assistance due to the occurrence of symptoms related to the study. The study statistics will be descriptive in terms of pain events, and the effect of the drugs will be evaluated in a statistical model suitable for the N-of-1 trial. Prucalopride is a 5-HT4 receptor agonist that accelerates gastric emptying, while buspirone is a 5-HT1A receptor agonist that enhances gastric accommodation function. The presumed pathophysiology underlying the patient's pain is retention of wine in the gastric lumen, causing pain. Stimulating gastric emptying with prucalopride or increasing the accommodation of the gastric fundus with buspirone could prevent or alleviate the pain crisis.
363 studies on the registry are indexed under Dyspepsia; 51 are open to participants now.
This study's enrollment of 1 is below the median of 87 across 297 interventional studies indexed under Dyspepsia.
Browse Dyspepsia studies →Universidade de Passo Fundo is the lead sponsor of 13 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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 10 mg 1 capsule orally 1 hour before the wine challenging (during a dinner), in five dinners (2 dinners per week)
Drug: Buspirone
placebo 1 capsule orally 1 hour before the wine challenging (during a dinner), in five dinners (2 dinners per week)
Drug: Placebo
prucalopride 2 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner
Also known as: Resolor
buspirone 10 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner
Also known as: Ansitec
placebo 1 hour before the challenge with intake of wine (200 ml) and a dinner
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)
Time frame: 2 hours after challenging with wine intake
Occurrence of side effects secondary to tested drugs
Registration by the patient (symptom diary) concerning the occurrence (yes/not) of side effects potentially related with prucalopride (abdominal cramps, nausea, diarrhea, and headache) and buspirone (drowsiness and dizziness) after each ethylic challange
Time frame: 12 hours after drugs intake
Plan to share: No
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Universidade de Passo Fundo