Buspirone for weak or absent esophageal peristalsis
- Conditions
- ineffective motility or absent peristalsis
- Registration Number
- 2024-516667-91-00
- Lead Sponsor
- UZ Leuven
- Brief Summary
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, in supine position)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing, recruiting
- Sex
- Not specified
- Target Recruitment
- 25
Ineffective motility or absent contractility identified on HRiM
Primary complaint of dysphagia for a minimum of 2 months
Age > 18 years
No anatomical cause for symptoms
No hiatal hernia ≥3 cm
- Sexually active women of childbearing potential participating in the study must be using an appropriate form of contraception.
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.
Major psychiatric disorder.
Pregnancy or breastfeeding.
History of poor compliance.
History of/or current psychiatric illness that would interfere with ability to comply with protocol requirements or give informed consent.
History of alcohol or drug abuse that would interfere with ability to comply with protocol requirements.
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
QT c>450 ms.
Use of medication that effect cholinergic function such as anticholinergics, tricyclic antidepressants.
Concomitant promotility agents such as prucalopride or domperidone.
Concomitant use of more than one benzodiazepine.
Significant neurological, respiratory, hepatic, renal, hematological, cardiovascular, metabolic or gastrointestinal cerebrovascular disease as judged by the investigator.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in distal contractile integral (DCI, mm Hg*s*cm) between buspirone and placebo established on high resolution impedance manometry (HRiM), for the liquid bolus (5 mL) in supine position. Change in distal contractile integral (DCI, mm Hg*s*cm) between buspirone and placebo established on high resolution impedance manometry (HRiM), for the liquid bolus (5 mL) in supine position.
- Secondary Outcome Measures
Name Time Method Bolus Presence Time (BPT, s) Bolus Presence Time (BPT, s)
Bolus Flow Time (BFT, s) Bolus Flow Time (BFT, s)
Change in symptoms between placebo and buspirone during the HRiM with 3 types of boluses: A Likert score applied during all swallows: 1 (Normal), 2 (Slow passage of bolus), 3 (Stepwise passage), 4 (Partial Blockage), 5 (Complete Blockage) Change in symptoms between placebo and buspirone during the HRiM with 3 types of boluses: A Likert score applied during all swallows: 1 (Normal), 2 (Slow passage of bolus), 3 (Stepwise passage), 4 (Partial Blockage), 5 (Complete Blockage)
Proximal Contractile Integral (PCI es., mmHg.s.cm) Proximal Contractile Integral (PCI es., mmHg.s.cm)
Distal Contractile Integral (DCI, mmHg.s.cm) Distal Contractile Integral (DCI, mmHg.s.cm)
Largest Break Size (cm) Largest Break Size (cm)
Distal Latency (DL, s) Distal Latency (DL, s)
Integrated Relaxation Pressure 4s (IRP4s, mmHg) Integrated Relaxation Pressure 4s (IRP4s, mmHg)
Pressure Flow Index (PFI) Pressure Flow Index (PFI)
Impedance Ratio (IR) Impedance Ratio (IR)
Distension Pressure Accommodation (DPA, mmHg) Distension Pressure Accommodation (DPA, mmHg)
Distension Pressure Emptying (DPE, mmHg) Distension Pressure Emptying (DPE, mmHg)
Ramp Pressure (RP, mmHg/s) Ramp Pressure (RP, mmHg/s)
Contractile Segment Impedance (CSI, Ohms) Contractile Segment Impedance (CSI, Ohms)
Esophago-Gastric Junction Resting Pressure (EGJ Rest.P, mmHg) Esophago-Gastric Junction Resting Pressure (EGJ Rest.P, mmHg)
Esophago-Gastric Junction Contractile Integral (EGJCI, mmHg.cm) Esophago-Gastric Junction Contractile Integral (EGJCI, mmHg.cm)
Lower Esophageal Sphincter – Crural Diaphragm (LES-CD, mm) Lower Esophageal Sphincter – Crural Diaphragm (LES-CD, mm)
Mayo Dysphagia Questionnaire Mayo Dysphagia Questionnaire
Overall Treatment Evaluation Overall Treatment Evaluation
Overall Symptom Severity Overall Symptom Severity
Trial Locations
- Locations (1)
UZ Leuven
🇧🇪Leuven, Belgium
UZ Leuven🇧🇪Leuven, BelgiumJan TackSite contact+3216344225jan.tack@kuleuven.be