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

Gastroesophageal Reflux Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04352686
• Other study ID #: Busprione MuMoS HV
• Status: Completed
• Phase: N/A
• Start date: February 2012
• Est. completion date: November 2012

Study information

• Verified date: April 2020
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• Buspirone
Administration of buspirone to assess esophageal sensitivity
• Placebo
Administration of placebo to assess differences in esophageal sensitivity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in sensitivity to thermal stimulation	To detect changes in thermal stimulation for sensitivity	After 30 minutes after administration buspirone
Secondary	Change in sensitivity to mechanical stimulation	To detect changes in mechanical stimulation for sensitivity	After 45 minutes after administration buspirone
Secondary	Change in sensitivity to electrical stimulation	To detect changes in electrical stimulation for sensitivity	After 60 minutes after administration buspirone
Secondary	Change in sensitivity to chemical stimulation	To detect changes in chemical stimulation for sensitivity	After 75 minutes after administration buspirone
Secondary	Change in positive and negative affect score	to detect change in affect of the multimodal stimulation	At the beginning of the study and at the end of the multimodal stimulation
Secondary	Change in state trait and anxiety score	to detect changes in the score due to the multimodal stimulation	At the beginning of the study and at the end of the multimodal stimulation