Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux

March 22, 2025 updated by: Muhammad Aamir Latif

Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux, a Comparative Study of Short Trial.

This study aimed to fill the gaps by comparing the efficacy and safety of ondansetron versus metoclopramide for the control of gastroesophageal reflux disorder in children 1-12 months of age, presenting at the outdoor department of Allama Iqbal Teaching Hospital, Dera Ghazi Khan.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Since the FDA issued a warning against domperidone as a potential proarrhythmic drug in children, its use has been widely discouraged and no longer recommended in safe practices. This warning at one end persuaded the pediatricians to search for the new options; on the other end, the use of metoclopramide, H2 receptor antagonists, and alginate-based medications became superfluous, opening a wide area of research in search of the next potential best option. The findings of this study would add to the existing statistics and help clinicians to have better outcomes among infants with gastroesophageal reflux disorder.

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Dera Ghazi Khan, Punjab, Pakistan, 32200
        • Allama Iqbal teaching hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Infants of any gender
  • Aged 1-12 months
  • Presenting with symptoms of gastroesophageal reflux disease not responding to dietary modifications and positioning
  • Afebrile at the time of presentation
  • Vitally stable

Exclusion Criteria:

  • No evidence of hypertrophic pyloric stenosis on ultrasonography
  • Children with congenital heart disease
  • Any history of prior illness associated with symptoms
  • With abdominal distension
  • Neurological impairment, like developmentally delayed, grossly microcephalic

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Metoclopramide group
Patients were prescribed metoclopramide twice a day for one week.
Drug: Metoclopramide
Patients were prescribed metoclopramide twice a day for one week.
Experimental: Ondansetron
Patients in this group were put on oral ondansetron in BD doses for one week.
Drug: Ondansetron
Patients were put on oral ondansetron in BD doses for one week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response to treatment
Time Frame: 1 week
Reduction in vomiting episodes and preservation/increase in previous weight
1 week
Treatment-emerged adverse events
Time Frame: 1 week
The occurrence of diarrhea, constipation, lethargy/somnolence, dark urine, headache, and warm flushes was considered as treatment-emerged adverse events.
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muhammad Aamir Latif

Investigators

  • Principal Investigator: Irum Jabeen, FCPS, Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan
  • Principal Investigator: Asma Akbar, FCPS, Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

March 22, 2025

First Submitted That Met QC Criteria

March 22, 2025

First Posted (Actual)

March 27, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 22, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DRIRUMDGKHAN

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

If a reasonable request is made, data can be shared.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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