DyspepsiaPhase 1/2NCT05377619
Preventing Gastric Glitch With Prucalopride and Buspirone: N-of-1 Clinical Trial
A Phase 1/2 study testing Prucalopride and Buspirone in people with Dyspepsia, run by Universidade de Passo Fundo at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Prucalopride and Buspirone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteBrazil
- Study dates
- 6 Jan 2022to 6 Mar 2022
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult patient suffering from severe gastric pain after ingestion of a small amount of wine
Who cannot join
- N/A (N-of-1 trial)
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010-080
About this study
Official title: Gastric Glitch: a New Functional Disease Treated With Prucalopride and Buspirone in a N-of-1 Double-blind Clinical Trial
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.
Read the detailed description
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.
- Conditions
- Dyspepsia
- Being tested
- Prucalopride, Buspirone, Placebo
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrucaloprideDrug
Also called Resolor
prucalopride 2 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner
BuspironeDrug
Also called Ansitec
buspirone 10 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner
PlaceboDrug
placebo 1 hour before the challenge with intake of wine (200 ml) and a dinner
| Study group | Role | What they receive |
|---|---|---|
| prucalopride | Experimental | prucalopride 2 mg 1 capsule orally 1 hour before the wine challenging (during a dinner), in five dinners (2 dinners per week) Receives: 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) Receives: 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) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 2 hours after challenging with wine intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2022
- Study start6 Jan 2022
- Primary completion6 Mar 2022
- Study completion6 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- N-of-1 trial testing the effect of prucalopride, buspirone and placebo on the prevention of alcohol-induced gastric glitch
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade de Passo Fundo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Fornari, Universidade de Passo Fundo
- Investigators
- Fernando Fornari, Principal investigator, University of Passo Fundo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05377619
- Sponsor's protocol ID
- 5.151.164
- Status last verified
- May 2022
- First submitted
- 20 Apr 2022
- Last updated
- 17 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Glitch: a New Functional Disease Treated With Prucalopride and Buspirone in a N-of-1 Double-blind Clinical Trial
- ClinicalTrials.gov ID
- NCT05377619
- Acronym / sponsor ID
- 5.151.164
- Conditions
- Dyspepsia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Universidade de Passo FundoUniversity, hospital or other
- Study start
- 6 Jan 2022 (actual)
- Primary completion
- 6 Mar 2022 (actual)
- Study completion
- 6 Mar 2022 (actual)
- First posted
- 17 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- N-of-1 trial testing the effect of prucalopride, buspirone and placebo on the prevention of alcohol-induced gastric glitch
| Arm | Type | Receives |
|---|---|---|
| prucalopride | Experimental | Drug: Prucaloprideprucalopride 2 mg 1 capsule orally 1 hour before the wine challenging (during a dinner), in five dinners (2 dinners per week) |
| buspirone | Experimental | Drug: Buspironebuspirone 10 mg 1 capsule orally 1 hour before the wine challenging (during a dinner), in five dinners (2 dinners per week) |
| placebo | Placebo comparator | Drug: Placeboplacebo 1 capsule orally 1 hour before the wine challenging (during a dinner), in five dinners (2 dinners per week) |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- adult patient suffering from severe gastric pain after ingestion of a small amount of wine
Key exclusion criteria (1 listed)
- N/A (N-of-1 trial)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PrucaloprideAlso: Resolorprucalopride 2 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner | Drug | prucalopride |
| BuspironeAlso: Ansitecbuspirone 10 mg 1 hour before the challenge with intake of wine (200 ml) and a dinner | Drug | buspirone |
| Placeboplacebo 1 hour before the challenge with intake of wine (200 ml) and a dinner | Drug | placebo |
Primary outcome
Pain severity during gastric glitch crises
Time frame: 2 hours after challenging with wine intake
Pain severity scored by the patient using a Likert scale (1 = minimal / 10 = maximal pain) following wine intake (200 ml)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fernando Fornari principal investigator
University of Passo Fundo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Prucalopride and Buspirone in people with Dyspepsia, run by Universidade de Passo Fundo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain severity during gastric glitch crises (time frame: 2 hours after challenging with wine intake). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.