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Gastrointestinal Dysmotility on Aspiration Risk

NCT05455359 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-12-26

No results posted yet for this study

Summary

The hypothesis of this study is that esophageal and gastric dysmotility increase the risk of developing aspiration-associated symptoms in children with neurologic impairment. The investigators are conducting a ten week cross over study comparing prucalopride to famotidine for the treatment of aspiration-associated symptoms.

Conditions

  • Esophageal Motility Disorders
  • Gastric Motor Dysfunction
  • Aspiration Pneumonia
  • Gastro Esophageal Reflux

Interventions

DRUG

Prucalopride

Prucalopride 0.04 mg/kg/day

DRUG

Famotidine

Famotidine 0.4 mg/kg/day

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
5 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-13
Primary Completion
2027-05-31
Completion
2027-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05455359 on ClinicalTrials.gov