Back to resultsEffects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers
Primary Purpose
Gastroesophageal Reflux
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Buspirone
Placebo
Sponsored by
About this trial
This is an interventional other trial for Gastroesophageal Reflux
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Buspirone
Placebo
Arm Description
Buspirone 20 mg per oral
Placebo
Outcomes
Primary Outcome Measures
Change in sensitivity to thermal stimulation
To detect changes in thermal stimulation for sensitivity
Secondary Outcome Measures
Change in sensitivity to mechanical stimulation
To detect changes in mechanical stimulation for sensitivity
Change in sensitivity to electrical stimulation
To detect changes in electrical stimulation for sensitivity
Change in sensitivity to chemical stimulation
To detect changes in chemical stimulation for sensitivity
Change in positive and negative affect score
to detect change in affect of the multimodal stimulation
Change in state trait and anxiety score
to detect changes in the score due to the multimodal stimulation
Full Information
NCT ID
NCT04352686
First Posted
April 15, 2020
Last Updated
April 15, 2020
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT04352686
Brief Title
Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers
Official Title
Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
February 2012 (Actual)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
November 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate if buspirone, a partial 5-HT-1A receptor agonist, is able to modify esophageal sensitivity, assessed by the multimodal stimulation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroesophageal Reflux
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Buspirone
Arm Type
Active Comparator
Arm Description
Buspirone 20 mg per oral
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Buspirone
Intervention Description
Administration of buspirone to assess esophageal sensitivity
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administration of placebo to assess differences in esophageal sensitivity
Primary Outcome Measure Information:
Title
Change in sensitivity to thermal stimulation
Description
To detect changes in thermal stimulation for sensitivity
Time Frame
After 30 minutes after administration buspirone
Secondary Outcome Measure Information:
Title
Change in sensitivity to mechanical stimulation
Description
To detect changes in mechanical stimulation for sensitivity
Time Frame
After 45 minutes after administration buspirone
Title
Change in sensitivity to electrical stimulation
Description
To detect changes in electrical stimulation for sensitivity
Time Frame
After 60 minutes after administration buspirone
Title
Change in sensitivity to chemical stimulation
Description
To detect changes in chemical stimulation for sensitivity
Time Frame
After 75 minutes after administration buspirone
Title
Change in positive and negative affect score
Description
to detect change in affect of the multimodal stimulation
Time Frame
At the beginning of the study and at the end of the multimodal stimulation
Title
Change in state trait and anxiety score
Description
to detect changes in the score due to the multimodal stimulation
Time Frame
At the beginning of the study and at the end of the multimodal stimulation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effects of Serotonin Agonist Buspirone on Multimodal Esophageal Stimulation in Healthy Volunteers
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