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

Not Applicable

Completed

• Conditions: Gastroesophageal Reflux
• Interventions: Drug: Placebo; Drug: Buspirone

• Registration Number: NCT04352686
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Primary Completion: 2012-09
• Study Completion: 2012-11
• Status Verified: 2020-04
• Study First Submitted: 2020-04-15
• Study First Submitted QC: 2020-04-15
• Last Update Submitted: 2020-04-15
• Study First Posted: 2020-04-20
• Last Update Posted: 2020-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• HV aged between 18 - 60 years

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Buspirone	Buspirone	Buspirone 20 mg per oral

Primary Outcome Measures

Name	Time	Method
Change in sensitivity to thermal stimulation	After 30 minutes after administration buspirone	To detect changes in thermal stimulation for sensitivity

Secondary Outcome Measures

Name	Time	Method
Change in positive and negative affect score	At the beginning of the study and at the end of the multimodal stimulation	to detect change in affect of the multimodal stimulation
Change in sensitivity to mechanical stimulation	After 45 minutes after administration buspirone	To detect changes in mechanical stimulation for sensitivity
Change in sensitivity to electrical stimulation	After 60 minutes after administration buspirone	To detect changes in electrical stimulation for sensitivity
Change in state trait and anxiety score	At the beginning of the study and at the end of the multimodal stimulation	to detect changes in the score due to the multimodal stimulation
Change in sensitivity to chemical stimulation	After 75 minutes after administration buspirone	To detect changes in chemical stimulation for sensitivity