Status:
COMPLETED
Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux
Lead Sponsor:
Muhammad Aamir Latif
Conditions:
Gastroesophageal Reflux Disorder
Eligibility:
All Genders
1-12 years
Phase:
NA
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, presenti...
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 e...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
290 Patients enrolled
Trial Details
Trial ID
NCT06898268
Start Date
July 1 2024
End Date
December 31 2024
Last Update
March 27 2025
Active Locations (1)
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1
Allama Iqbal Teaching Hospital
Dera Ghazi Khan, Punjab Province, Pakistan, 32200