Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers

NCT04352686 | Completed

• 1 other identifier: Busprione MuMoS HV
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

To investigate if buspirone, a partial 5-HT-1A receptor agonist, is able to modify esophageal sensitivity, assessed by the multimodal stimulation.

Conditions

Gastroesophageal Reflux

Outcome Measures

Primary Outcomes (1)

• Change in sensitivity to thermal stimulation

  To detect changes in thermal stimulation for sensitivity

  After 30 minutes after administration buspirone

Secondary Outcomes (5)

• Change in sensitivity to mechanical stimulation

  After 45 minutes after administration buspirone

• Change in sensitivity to electrical stimulation

  After 60 minutes after administration buspirone

• Change in sensitivity to chemical stimulation

  After 75 minutes after administration buspirone

• Change in positive and negative affect score

  At the beginning of the study and at the end of the multimodal stimulation

• Change in state trait and anxiety score

  At the beginning of the study and at the end of the multimodal stimulation

Study Arms (2)

Buspirone

ACTIVE COMPARATOR

Buspirone 20 mg per oral

Drug: Buspirone

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Buspirone DRUG

Administration of buspirone to assess esophageal sensitivity

Buspirone

Placebo DRUG

Administration of placebo to assess differences in esophageal sensitivity

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• HV aged between 18 - 60 years

You may not qualify if:

• history of psychiatric disease or a positive first degree psychiatric family history
• pregnancy or lactation
• concomitant administration of any centrally activating medication (anti-depressive medication, hypnotics, sedatives, anxiolytics, …)
• medication affecting esophageal motility
• significant co-morbidities (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic)
• prior history of esophageal, gastric surgery or endoscopic anti-reflux procedure
• history of gastrointestinal disease

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Buspirone

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr

Study Record Dates

• First Submitted: April 15, 2020
• First Posted: April 20, 2020
• Study Start: February 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: April 20, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share