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The effect of oral buspirone hydrochloride on esophageal motility, bolus transit and symptoms of dysphagia, in patients with poor esophageal motility: A randomized, double-blind, placebo controlled, cross-over trial with high resolution esophageal manometry and impedance.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-516667-91-00
Enrollment
25
Registered
2024-10-24
Start date
2019-09-10
Completion date
Unknown
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ineffective motility or absent peristalsis

Brief summary

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.

Detailed description

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), 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 Resting Pressure (EGJ Rest.P, mmHg), Esophago-Gastric Junction Contractile Integral (EGJCI, mmHg.cm), Lower Esophageal Sphincter – Crural Diaphragm (LES-CD, mm), Mayo Dysphagia Questionnaire, Overall Treatment Evaluation, Overall Symptom Severity

Interventions

Sponsors

UZ Leuven
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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), 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 Resting Pressure (EGJ Rest.P, mmHg), Esophago-Gastric Junction Contractile Integral (EGJCI, mmHg.cm), Lower Esophageal Sphincter – Crural Diaphragm (LES-CD, mm), Mayo Dysphagia Questionnaire, Overall Treatment Evaluation, Overall Symptom Severity

Countries

Belgium

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026