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The Effect of Acute Intake of Oral Buspirone Hydrochloride on Esophageal Motility, Bolus Transit and Symptoms of Dysphagia, in Patients with Ineffective Esophageal Motility: A Pilot, Open-label, Single Dosing Study with High-Resolution Esophageal Manometry and Impedance.

The Effect of Acute Intake of Oral Buspirone Hydrochloride on Esophageal Motility, Bolus Transit and Symptoms of Dysphagia, in Patients with Ineffective Esophageal Motility: A Pilot, Open-label, Single Dosing Study with High-Resolution Esophageal Manometry and Impedance.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2010-021390-36-BE
Enrollment
7
Registered
2010-06-30
Start date
2010-09-07
Completion date
Unknown
Last updated
2021-03-17

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

Conditions

Ineffective Esophageal Motility

Interventions

Trade Name: buspar Pharmaceutical Form: Tablet INN or Proposed INN: BUSPIRONE CAS Number: 36505847 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10-

Sponsors

uzleuven
Lead Sponsor

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 (neuromuscular, psychiatric, cardiovascular, pulmonary, endocrine, autoimmune, renal and hepatic). 5. A demonstrable obstructive cause of dysphagia. 6. Prior history of esophageal, ENT or gastric surgery or endoscopic antireflux procedure. 7. A clinical and manometric diagnosis of achalasia, diffuse esophageal spasm, nutcracker esophagus, or hypertensive lower esophageal sphincter (LES).

Design outcomes

Primary

MeasureTime frame
Main Objective: To investigate the acute effect of buspirone hydrochloride (buspar®) administered orally as two 10 mg tablets, on esophageal motility, bolus transit, and symptoms of dysphagia, in patients with IEM.;Secondary Objective: no secondary objectives;Primary end point(s): 1. Mean pressure wave amplitude at 4, 10 and 16 cm above LES, per swallow type and volume. 2. Mean bolus passage score per swallow type and volume. 3. Percentage of swallows with incomplete bolus transport, per swallow type and volume (impedance).—

Countries

Belgium

Outcome results

None listed

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