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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06898268

Enrollment

290

Registered

2025-03-27

Start date

2024-07-01

Completion date

2024-12-31

Last updated

2025-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux Disorder

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.

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.

Interventions

DRUGMetoclopramide

Patients were prescribed metoclopramide twice a day for one week.

DRUGOndansetron

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

1 Months to 12 Months

Healthy volunteers

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

Design outcomes

Primary

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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026