Effects of Serotonin Agonist Buspirone on Multimodal Esop... | NCT04352686

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

NCT04352686

Sponsor

Universitaire Ziekenhuizen KU Leuven

Status

Completed

Last Update Posted

Apr 20, 2020Actual

Enrollment

10Actual

Phase

Not Applicable

Conditions

Gastroesophageal Reflux

Interventions

Buspirone
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012Actual

Primary Completion Date

Sep 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Apr 15, 2020

First Submission Date that Met QC Criteria

Apr 15, 2020

First Posted Date

Apr 20, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 15, 2020

Last Update Posted Date

Apr 20, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Prof Dr Jan Tack, Prof Dr, Universitaire Ziekenhuizen KU LeuvenPrincipal Investigator

Lead Sponsor

Universitaire Ziekenhuizen KU LeuvenOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Buspirone	Active Comparator	Buspirone 20 mg per oral	Drug: Buspirone
Placebo	Placebo Comparator	Placebo	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Buspirone	Drug	Administration of buspirone to assess esophageal sensitivity	Buspirone

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in sensitivity to thermal stimulation	To detect changes in thermal stimulation for sensitivity	After 30 minutes after administration buspirone

Secondary Outcomes

Measure	Description	Time Frame
Change in sensitivity to mechanical stimulation	To detect changes in mechanical stimulation for sensitivity	After 45 minutes after administration buspirone
Change in sensitivity to electrical stimulation

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005764	Gastroesophageal Reflux

Ancestor Terms

ID	Term
D015154	Esophageal Motility Disorders
D003680	Deglutition Disorders
D004935	Esophageal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D002065	Buspirone

Ancestor Terms

ID	Term
D013141	Spiro Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided