The effect of Buspirone on the sensitivity of the esophagus in healthy volunteers.

The effect of Buspirone on esophageal sensitivity in healthy volunteers: a randomized, double-blind, placebo-controlled, single-dosing study.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005059-15-BE

Enrollment

Registered

2011-10-24

Start date

2012-02-03

Completion date

Unknown

Last updated

2021-04-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

altered esophageal sensitivity, gastro-esophageal reflux disease

Interventions

Trade Name: Bespar Product Name: Buspar Pharmaceutical Form: Tablet INN or Proposed INN: BUSPIRONE CAS Number: 36505-84-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration nu

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. age >18 and =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. a history of allergic reaction to buspirone, or multiple allergies to several foods and drugs 2. pregnancy, lactation 3. concomitant administration of monomine oxidase inhibitors (MAOI), verapamil, or diltiazem, or medications affecting esophageal motility 4. significant commorbidities (neuromuscuar, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic) 5. prior history of esophageal, ENT or gastric surgery or endoscopic antireflux procedure

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate the acute effect of buspirone hydrochloride (Bespar) administered orally as two 10mg tablets, on esophageal sensitivity in healthy volunteers.;Secondary Objective: no secondary objectives;Primary end point(s): Comparison of VAS (visual analogue scores) between healthy volunteers in esophageal stimulation;Timepoint(s) of evaluation of this end point: VAS scores will be compared between active treatment and placebo after completion of both visitis.	—

Measure

Time frame

Main Objective: To investigate the acute effect of buspirone hydrochloride (Bespar) administered orally as two 10mg tablets, on esophageal sensitivity in healthy volunteers.;Secondary Objective: no secondary objectives;Primary end point(s): Comparison of VAS (visual analogue scores) between healthy volunteers in esophageal stimulation;Timepoint(s) of evaluation of this end point: VAS scores will be compared between active treatment and placebo after completion of both visitis.

—

Secondary

Measure	Time frame
Secondary end point(s): no secondary end point;Timepoint(s) of evaluation of this end point: no secondary end point	—

Countries

Belgium

Contacts

Public ContactTARGID

KULeuven

veerle.boecxstaens@med.kuleuven.be003216340876

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026