Buspirone for Weak or Absent Esophageal Peristalsis
ConditionDysphagia, Esophageal
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversitaire Ziekenhuizen KU Leuven
About this trial
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).
Eligibility criteria
Qualifiers
A minimum of 18 years old;
Ineffective Esophageal Motility (IEM) or absent contractility, as determined on HRM in the last three months before inclusion in the study, using the Chicago classification v4.0 (1).
Have completed a gastro-duodenoscopy, within 12 months, showing no anatomical abnormality of the stomach or esophagus, which can explain the patients' symptoms.
History of dysphagia for at least 2 months, at least twice per week in the last month.
Disqualifiers
Endoscopic signs of severe erosive esophagitis (grade C or D, Los Angeles classification) on endoscopy performed off PPI treatment in the 12 months prior to screening, or ≥ grade B when endoscopy is performed during PPI treatment.
Systemic diseases, known to affect esophageal motility (i.e. systemic sclerosis)
Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed).
Hiatal hernia ≥3 cm
Trial design
Treatments tested in this trial
- Buspirone Hydrochloride 10 MG
- Placebo
Treatment groups
25 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov