drugset / Trial / NCT07031479

Efficacy of Itopride Versus Metoclopramide in Hospitalized Medicine Patients With High Gastric Residual Volume

NCT07031479

Phase 4 Not yet recruiting 86 enrolled Chulalongkorn University
RandomizedParallel-groupTriple-blindTreatment

Summary

A prospective randomized controlled trial included 86 patients in medicine ward who were diagnosed with feeding intolerance, defined as having a gastric residual volume greater than 200 ml. The patients were randomly assigned to two treatment groups: one receiving enteral metoclopramide and the other receiving intravenous metoclopramide. The primary outcome was the gastric residual volume at 72 hours after treatment. The secondary outcome was gastric residual volume at 24 hours and 7 days after treatment, administered-to-prescribed volume at 72 hours after treatment, the administered-to-target energy ratio and the administered-to-target protein ratio at 96 hours after treatment, the nutrition status evaluated by the Nutrition Alert Form at 7 days after treatment, incidence of adverse events (arrhythmia, pneumonia, diarrhea, vomiting, aspiration), length of hospital stay, ICU length of stay and in-hospital mortality.

Timeline

Start
2025-07-01
Primary completion
2026-06-30
Completion
2026-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Itopride Small molecule 50 mg Other
Comparator Metoclopramide Small molecule 5 mg Intravenous
Comparator Metoclopramide Small molecule 10 mg Intravenous

Indications

No indication recorded.