Gastroesophageal Reflux DisorderNCT06898268
Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux
A study testing Metoclopramide and Ondansetron in people with Gastroesophageal Reflux Disorder, run by Muhammad Aamir Latif at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 12 months
- Conditions the study is for
- Gastroesophageal Reflux Disorder
- What is being tested?
- Metoclopramide and Ondansetron
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jul 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Allama Iqbal Teaching Hospital
Dera Ghazi Khan, Punjab Province, 32200
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastroesophageal Reflux Disorder
- Being tested
- Metoclopramide, Ondansetron
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetoclopramideDrug
Patients were prescribed metoclopramide twice a day for one week.
OndansetronDrug
Patients were put on oral ondansetron in BD doses for one week.
| Study group | Role | What they receive |
|---|---|---|
| Metoclopramide group | Experimental | Patients were prescribed metoclopramide twice a day for one week. Receives: Drug: Metoclopramide |
| Ondansetron | Experimental | Patients in this group were put on oral ondansetron in BD doses for one week. Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment
Reduction in vomiting episodes and preservation/increase in previous weight
Measured: 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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start1 Jul 2024
- Primary completion31 Dec 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muhammad Aamir Latif
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Muhammad Aamir Latif, RESnTEC, Institute of Research
- Investigators
- Irum Jabeen, FCPS, Principal investigator, Allama Iqbal Teaching Hospital, Dera Ghazi Khan, PakistanAsma Akbar, FCPS, Principal investigator, Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898268
- Sponsor's protocol ID
- DRIRUMDGKHAN
- Status last verified
- Mar 2025
- First submitted
- 22 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: If a reasonable request is made, data can be shared.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux, a Comparative Study of Short Trial.
- ClinicalTrials.gov ID
- NCT06898268
- Acronym / sponsor ID
- DRIRUMDGKHAN
- Conditions
- Gastroesophageal Reflux Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 290 participants (actual)
- Lead sponsor
- Muhammad Aamir LatifUniversity, hospital or other
- Study start
- 1 Jul 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metoclopramide group | Experimental | Drug: MetoclopramidePatients were prescribed metoclopramide twice a day for one week. |
| Ondansetron | Experimental | Drug: OndansetronPatients in this group were put on oral ondansetron in BD doses for one week. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetoclopramidePatients were prescribed metoclopramide twice a day for one week. | Drug | Metoclopramide group |
| OndansetronPatients were put on oral ondansetron in BD doses for one week. | Drug | Ondansetron |
Primary outcome
Response to treatment
Time frame: 1 week
Reduction in vomiting episodes and preservation/increase in previous weight
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No. If a reasonable request is made, data can be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Irum Jabeen, FCPS principal investigator
Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan
Asma Akbar, FCPS principal investigator
Allama Iqbal Teaching Hospital, Dera Ghazi Khan, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metoclopramide and Ondansetron in people with Gastroesophageal Reflux Disorder, run by Muhammad Aamir Latif at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response to treatment (time frame: 1 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.