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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Buspirone Hydrochloride 10 MG
Drug4 weeks of treatment with buspirone
Placebo
Drug4 weeks of treatment with placebo
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: Buspirone => Washout => PlaceboExperimental treatment 2 interventions
Group B: Placebo => Washout => BuspironeExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
HRiM Manometric Features: DCI 5ml supine
Changes in distal contractile integral (DCI, in mmHg\*s\*cm) between buspirone and placebo. DCI is established on HRiM. As primary endpoint, we will focus on the values for DCI for the liquid bolus, 5 ml in supine position.
Time frame
During manometric assessment after 4 weeks of treatmentSecondary outcomes
1
Bolus passage score
Patients will evaluate the perception of each swallow during the manometric assessment via the following Likert score: 1-Normal, 2-Slow passage of bolus, 3-Stepwise passage, 4-Partial Blockage, 5-Complete Blockage.
Time frame
During manometric assessment after 4 weeks of treatment2
HRiM Manometric Features: PCI
Pharyngeal Esophageal Contractile Integral (PCI es., mm.Hg.s.cm)
Time frame
During manometric assessment after 4 weeks of treatment3
HRiM Manometric Features: DCI
Distal Esophageal Contractile Integral (DCI, mmHg.s.cm)
Time frame
During manometric assessment after 4 weeks of treatment4
HRiM Manometric Features: Largest Break Size
Largest Break Size (cm)
Time frame
During manometric assessment after 4 weeks of treatmentSponsors and contacts
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Source ClinicalTrials.gov