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

NCT07031479 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: 0971/67
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Feeding Intolerance

Keywords

gastric residual volume; metoclopramide; itopride

Outcome Measures

Primary Outcomes (1)

• Mean gastric residual volume (in mL) on day 3 after initiation of prokinetics

  Mean gastric residual volume (in mL) on day 3 after initiation of prokinetics. The gastric residual volume was recorded four times daily, prior to feeding.

  Day3

Secondary Outcomes (7)

• Mean gastric residual volume (in mL) on day 1 after initiation of prokinetics

  Day1

• Mean gastric residual volume (in mL) on day 7 after initiation of prokinetics

  Day 7

• Percentage of prescribed enteral nutrition volume successfully administered on day 3 after initiation of prokinetics

  Day 3

• Percentage of target enteral nutrition energy successfully administered on day 4 after initiation of prokinetics

  Day 4

• Percentage of target enteral nutrition protein successfully administered on day 4 after initiation of prokinetics

  Day 4

Study Arms (2)

Itopride

EXPERIMENTAL

Enteral Itopride (50 mg enterally tid ac)

Drug: Itopride HCI 50 mg

Metoclopramide

ACTIVE COMPARATOR

Intravenous Metoclopramide (10 mg IV q 6 hours) CrCl 15-60 ml/min: Metoclopramide 5 mg IV q 6 hours CrCl \<15 ml/min: Metoclopramide 5 mg IV q 12 hours Hepatic impairment/ cirrhosis: Metoclopramide 5 mg IV q 6 hours

Drug: Metoclopramide 10 mg ampoule

Interventions

Itopride HCI 50 mg DRUG

Enteral Itopride 50 mg enterally tid ac

Itopride

Metoclopramide 10 mg ampoule DRUG

Intravenous Metoclopramide (10 mg IV q 6 hours) CrCl 15-60 ml/min: Metoclopramide 5 mg IV q 6 hours CrCl \<15 ml/min: Metoclopramide 5 mg IV q 12 hours Hepatic impairment/ cirrhosis: Metoclopramide 5 mg IV q 6 hours

Metoclopramide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized medical patients aged over 18 years who were receiving enteral feeding and had a gastric residual volume (GRV) ≥ 200 ml

You may not qualify if:

• Use of any prokinetic drug within 24 hours before participating in the study
• Known hypersensitivity or contraindication to Metoclopramide or Itopride
• Prolonged QTc interval \> 460 ms in female \>440 ms in male
• Hemodynamic instability
• GI surgery ≤ 6 weeks before enrollment in the study
• History of esophagectomy or gastrectomy
• Pregnancy
• Suspicious or confirmed gastrointestinal obstruction or gastrointestinal hemorrhage or gastrointestinal perforation
• Epilepsy or currently use of anti-epileptic drug
• Acute CNS infection or severe brain injury
• Parkinson's disease
• Confirmed or suspected pheochromocytoma
• History of tardive dyskinesia, history of methemoglobinemia.

Sponsors & Collaborators

• Chulalongkorn University: lead

MeSH Terms

Interventions

Metoclopramide

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Study Officials

• Narisorn Lakananurak, MD.

  Chulalongkorn University

  STUDY DIRECTOR

Central Study Contacts

Sasicha Kitphati, MD.

CONTACT

+66819244809; kitphati.s@gmail.com

Narisorn Lakananurak, MD.

CONTACT

+66853347979; Narisorn.l@chula.ac.th

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled trial

Study Record Dates

• First Submitted: April 20, 2025
• First Posted: June 22, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share