Patients with complaints of dysphagia and poor esophageal motility
Conditions
Interventions
Trade Name: Buspirone
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
KU Leuven - TARGID
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. A minimum of 18 years old; 2. 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. IEM is defined as >70% ineffective or =50% failed swallows with a normal integrated relaxation pressure (IRP4). IEM includes a weak contraction (DCI = 100 mmHg·s·cm and 5 cm length) in the 20-mmHg isobaric contour with DCI > 450 mmHg·s·cm). Absent contractility is defined as 100% failed swallows (DCI =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Endoscopic signs of severe erosive esophagitis (grade C or D, Los Angeles classification) on endoscopy performed during PPI treatment in the 12 months prior to screening, or = grade B when endoscopy is performed off PPI treatment. 2. Systemic diseases, known to affect esophageal motility (i.e. systemic sclerosis) 3. Surgery in the thorax or in the upper part of the abdomen (appendectomy and cholecystectomy are allowed). 4. QT c>450 ms. 5. Use of medication that effect cholinergic function such as anticholinergics, tricyclic antidepressants. 6. Concomitant promotility agents such as prucalopride or domperidone. 7. Concomitant use of benzodiazepines. 8. Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator. 9. Major psychiatric disorder. 10. Pregnancy or breastfeeding. 11. History of poor compliance. 12. History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent. 13. History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the effect of buspirone on high resolution manometry parameters (specifically: distal contractile integral, DCI) in patients with poor esophageal motility during a high resolution impedance manometry with 3 types of boluses (on liquid bolus, 5mL);Secondary Objective: To investigate the effect of buspirone vs. placebo on several esophageal and EGJ pressure flow parameters (PCI es., DCI, Largest Break Size, DL, IRP4s, PFI, IR, DPA, DPE, RP, CSI, BPT, BFT, EGJ Rest.P, EGJCI, LES-CD) as measured by high resolution impedance manometry To investigate the influence of buspirone on changes in symptoms using the validated Mayo Dysphagia Questionnaire To investigate the influence of buspirone on changes in overall treatment evaluation (OTE) and overall symptom severity (OSS) ;Primary end point(s): Changes in distal contractile integral (DCI, in mm Hg*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. ;Timepoint(s) of evaluation of this end point: DCI is measured after intake of buspirone or placebo for 4 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Bolus passage score A Likert score applied during all swallows: 1-Normal, 2-Slow passage of bolus, 3-Stepwise passage, 4-Partial Blockage, 5-Complete Blockage. a) Mean score for each type of swallow b) Percentage of swallows with a score =4, averaged for each type of swallow. High-resolution impedance manometry ESOPHAGUS Proximal Contractile Integral (PCI es., mmHg.s.cm) Distal Contractile Integral (DCI, mmHg.s.cm) Largest Break Size (cm) Distal Latency (DL, s) Integrated Relaxation Pressure 4s (IRP4s, mmHg) Pressure Flow Index (PFI) Impedance Ratio (IR) Distension Pressure Accommodation (DPA, mmHg) Distension Pressure Emptying (DPE, mmHg) Ramp Pressure (RP, mmHg/s) Contractile Segment Impedance (CSI, Ohms) Bolus Presence Time (BPT, s) Bolus Flow Time (BFT, s) ESOPHAGO-GASTRIC JUNCTION (EGJ) Esophago-Gastric Junction Resting Pressure (EGJ Rest.P, mmHg) Esophago-Gastric Junction Contractile Integral (EGJCI, mmHg.cm) Lower Esophageal Sphincter – Crural Diaphragm (LES-CD, mm) a) Mayo Dysphagia Questionnaires b) Overall Treatment Evaluation (OTE) c) Overall Symptom Severity (OSS) ;Timepoint(s) of evaluation of this end point: All parameters are measured after intake of buspirone or placebo for 4 weeks. | — |
Countries
Belgium
Contacts
Public ContactMarthe Everaert
KU Leuven - TARGID
Outcome results
None listed