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.

Phase 1

• Conditions: Ineffective Esophageal Motility

• Registration Number: EUCTR2010-021390-36-BE
• Lead Sponsor: uzleuven

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-30
• Study Completion: 2013-02-19
• Last Update Posted: 17 March 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1.Age >18 and <60 years.
2.Minimum duration of dysphagia history: 2 months.
3.Recent esophago-gastroscopy.
4.A baseline esophageal manometric profile with at least 30% of wet swallows exhibiting any combination of the following abnormalities: (i) non-transmitted contractions (ii) low amplitude contractions (peristaltic contractions with amplitude <30 mmHg in the distal esophagus)1 (iii) a = 2 cm defect in the 30 mm Hg isobaric contour of the distal esophageal segment.19

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified