Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT05629325

Buspirone for Weak or Absent Esophageal Peristalsis

Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2024-07-03

25

Participants Needed

1

Research Sites

168 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This is a randomized, double-blind, placebo-controlled, cross-over clinical trial of buspirone in patients with complaints of dysphagia due to poor esophageal motility. The goal of this clinical trial is to study the effect of buspirone on esophageal motility by performing high resolution impedance manometry (HRiM).

CONDITIONS

Official Title

Buspirone for Weak or Absent Esophageal Peristalsis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Diagnosed with Ineffective Esophageal Motility (IEM) or absent contractility by HRM within the last three months using Chicago classification v4.0
  • IEM defined as >70% ineffective or ≥50% failed swallows with normal integrated relaxation pressure
  • Absent contractility defined as 100% failed swallows with normal integrated relaxation pressure
  • Completed gastro-duodenoscopy within 12 months showing no anatomical abnormalities of stomach or esophagus
  • History of dysphagia at least twice per week for at least 2 months
  • Sexually active women of childbearing potential must use medically acceptable contraception or have a negative pregnancy test
  • Able and willing to provide signed informed consent
Not Eligible

You will not qualify if you...

  • Severe erosive esophagitis (grade C or D off PPI, or ≥ grade B on PPI) on recent endoscopy
  • Systemic diseases affecting esophageal motility (e.g., systemic sclerosis)
  • Previous surgery in thorax or upper abdomen (except appendectomy or cholecystectomy)
  • Hiatal hernia 3 cm or larger
  • QTc interval >450 ms
  • Use of medications affecting cholinergic function such as anticholinergics or tricyclic antidepressants
  • Use of promotility agents like prucalopride or domperidone
  • Concurrent use of more than one benzodiazepine
  • Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic, gastrointestinal, or cerebrovascular diseases
  • Major psychiatric disorders
  • Pregnancy or breastfeeding
  • History of poor compliance
  • Psychiatric illness interfering with study participation or consent
  • History of alcohol or drug abuse interfering with study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University Hospitals Leuven

Leuven, Vlaams-Brabant, Belgium, 3000

Actively Recruiting

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Research Team

J

Jan Tack

CONTACT

K

KU Leuven

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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