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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2012-11-30

Brief Summary

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

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Detailed Description

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Conditions

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Gastroesophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Buspirone

Buspirone 20 mg per oral

Group Type ACTIVE_COMPARATOR

Buspirone

Intervention Type DRUG

Administration of buspirone to assess esophageal sensitivity

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administration of placebo to assess differences in esophageal sensitivity

Interventions

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Buspirone

Administration of buspirone to assess esophageal sensitivity

Intervention Type DRUG

Placebo

Administration of placebo to assess differences in esophageal sensitivity

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes