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

NCT06898268 | Completed

• 1 other identifier: DRIRUMDGKHAN
• Study Type: interventional
• Target: 290
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gastroesophageal Reflux Disorder

Outcome Measures

Primary Outcomes (2)

• Response to treatment

  Reduction in vomiting episodes and preservation/increase in previous weight

  1 week

• Treatment-emerged adverse events

  The occurrence of diarrhea, constipation, lethargy/somnolence, dark urine, headache, and warm flushes was considered as treatment-emerged adverse events.

  1 week

Study Arms (2)

Metoclopramide group

EXPERIMENTAL

Patients were prescribed metoclopramide twice a day for one week.

Drug: Metoclopramide

Ondansetron

EXPERIMENTAL

Patients in this group were put on oral ondansetron in BD doses for one week.

Drug: Ondansetron

Interventions

Metoclopramide DRUG

Patients were prescribed metoclopramide twice a day for one week.

Metoclopramide group

Ondansetron DRUG

Patients were put on oral ondansetron in BD doses for one week.

Ondansetron

Eligibility Criteria

• Age: 1 Month - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Muhammad Aamir Latif: lead

Study Sites (1)

Allama Iqbal Teaching Hospital

Dera Ghazi Khan, Punjab Province, 32200, Pakistan

Location

MeSH Terms

Interventions

Metoclopramide; Ondansetron

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; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Irum Jabeen, FCPS

  Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan

  PRINCIPAL INVESTIGATOR

• Asma Akbar, FCPS

  Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Consultant

Study Record Dates

• First Submitted: March 22, 2025
• First Posted: March 27, 2025
• Study Start: July 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)