Acute GastroenteritisPhase 3NCT02619201
Antiemetic Efficacy of Ondansetron Versus Metoclopramide
A Phase 3 study testing Ondansetron and metoclopramide in people with Acute Gastroenteritis and Vomiting, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.
Trial summary
Acute gastroenteritis (GEA) is a public health problem at present, the main cause of vomiting and consultation in emergencies in children under 5 years. Worldwide, there are about 2 million deaths per year due to gastroenteritis in children under 5 years. Read more about this study
- Who is it for?
- Ages 1 year to 5 years
- Conditions the study is for
- Acute Gastroenteritis, Vomiting
- What is being tested?
- Ondansetron and metoclopramide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Nov 2016
- Phase
- Phase 3
- 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 year to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Orally intolerance
- More than 2 vomiting in the last 24 hours
- Without antiemetic therapy within 24 hours of the clinical picture
- Patients with or without diarrhea
Who cannot join
- Previous abdominal surgery
- Suspected surgical abdominal
- Vomiting bile
- Hypersensitivity to Ondansetron and Metoclopramide
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of Efficacy of Ondansetron Versus Metoclopramide for Vomiting in Children With Acute Gastroenteritis: Randomized Controlled Clinical Trial
Acute gastroenteritis (GEA) is a public health problem at present, the main cause of vomiting and consultation in emergencies in children under 5 years. Worldwide, there are about 2 million deaths per year due to gastroenteritis in children under 5 years.
In Mexico, the mortality rate by age in 2013, recorded 28 deaths per 100,000 boys and girls, in 2013 in our country 2.5 million children between 5 and 17 years engaged in an economic activity. The occupancy rate for the child population was 8.6: 11.4 for boys and 5.8 for girls.
NICE guidance gastroenteritis defined as a transient disorder caused by an enteric infection and characterized by a sudden onset of diarrhea with or without vomiting
Read the detailed description
It will be conducted a randomized controlled double-blinded study in the Emergency service of the Naval General Hospital of High Specialty in the Mexico City. The period of patient inclusion in the study is November 2015 to November 2016.
The selections of the patients are children between 1 and 5 years who come to the emergency room with symptoms of acute gastroenteritis with vomiting and intolerance of oral route.
Treatments were randomly assigned eligible patients on admission in the emergency department
The primary endpoint was evaluated at 15 minutes after treatment application:
- Treatment 1: Ondansetron was administered intravenous dose (0.15mg/kg/doses) Diluted in 20 ml saline and administered intravenously 5 minutes
- Treatment 2: Metoclopramide was administered intravenous dose (0.15mg/kg/doses) Diluted in 20 ml saline and administered intravenously 5 minutes
The administration of intravenous medications, will be held in the observation area of the emergency department of pediatrics under monitoring continuo vital signs during application and 15 minutes after treatment.
At 15 minutes after administration, the mouth with oral electrolyte begins by assessing your tolerance, 30 minutes to progress to the astringent diet.
It will follow up with patient assessment in the emergency department of pediatrics, 3 hours after having established the treatment, in order to corroborate the remission of vomiting, it is graduation of home otherwise he will enter hospital.
Primary objective Cumulative rate of cessation of vomiting
secondary objectives
- Compare the number of vomiting episodes with the administration of ondansetron vs metoclopramide
- Compare time duration in which the oral route is restarted.
- Compare hospital admission rate
- Describe adverse effects in both groups
Inclusion Criteria:
- Orally intolerance
- More than 2 vomiting in the last 24 hours
- Without antiemetic therapy within 24 hours of the clinical picture
- Patients with or without diarrhea
Exclusion Criteria:
- Previous abdominal surgery
- Suspected surgical abdominal
- vomiting bile
- Hypersensitivity to Ondansetron and Metoclopramide
- Conditions
- Acute Gastroenteritis, Vomiting
- Being tested
- Ondansetron, metoclopramide
- Keywords
- vomiting in children, ondansetron, metoclopramide, antiemetics
- Medical subject headings
- Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called OD
An intravenous dose of ondansetron ( 0.15mg /kg / doses ) .
metoclopramideDrug
Also called MT
An intravenous dose of metoclopramide ( 0.15mg /kg / doses ) .
| Study group | Role | What they receive |
|---|---|---|
| ondansetron | Experimental | An intravenous dose of ondansetron ( 0.15mg /kg / doses ) Diluted in 20 ml of saline and administer intravenously in 5 minutes Receives: Drug: Ondansetron |
| metoclopramide | Active comparator | An intravenous dose of metoclopramide ( 0.15mg /kg / doses ) Diluted in 20 ml of saline and administer intravenously in 5 minutes Receives: Drug: metoclopramide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative rate of vomiting after cessation of drug administration
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2015 (estimated)
- Study startNov 2015
- Primary completionMay 2016 (estimated)
- Study completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Acute GastroenteritisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico Naval
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Yaneth Miranda Tecuautzin, medicine, Principal investigator, Secretaria de Marina-Armada de México (Mexican Navy)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02619201
- Sponsor's protocol ID
- HGNAE-10
- Status last verified
- Oct 2015
- First submitted
- 25 Nov 2015
- Last updated
- 2 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Herikstad H, Yang S, Van Gilder TJ, Vugia D, Hadler J, Blake P, Deneen V, Shiferaw B, Angulo FJ. A population-based estimate of the burden of diarrhoeal illness in the United States: FoodNet, 1996-7. Epidemiol Infect. 2002 Aug;129(1):9-17. doi: 10.1017/s0950268801006628.
PubMed 12211601Guarino A, Albano F, Ashkenazi S, Gendrel D, Hoekstra JH, Shamir R, Szajewska H; ESPGHAN/ESPID Evidence-Based Guidelines for the Management of Acute Gastroenteritis in Children in Europe Expert Working Group. European Society for Paediatric Gastroenterology, Hepatology, and Nutrition/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe: executive summary. J Pediatr Gastroenterol Nutr. 2008 May;46(5):619-21. doi: 10.1097/MPG.0b013e31816e219e. No abstract available.
PubMed 18493225Haque KN, al-Frayh A, el-Rifai R. Is it necessary to regraduate milk after acute gastroenteritis in children? Trop Geogr Med. 1983 Dec;35(4):369-73.
PubMed 6689452Carter B, Fedorowicz Z. Antiemetic treatment for acute gastroenteritis in children: an updated Cochrane systematic review with meta-analysis and mixed treatment comparison in a Bayesian framework. BMJ Open. 2012 Jul 19;2(4):e000622. doi: 10.1136/bmjopen-2011-000622. Print 2012.
PubMed 22815462National Collaborating Centre for Women's and Children's Health (UK). Diarrhoea and Vomiting Caused by Gastroenteritis: Diagnosis, Assessment and Management in Children Younger than 5 Years. London: RCOG Press; 2009 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK63844/
PubMed 22132432Atia AN, Buchman AL. Oral rehydration solutions in non-cholera diarrhea: a review. Am J Gastroenterol. 2009 Oct;104(10):2596-604; quiz 2605. doi: 10.1038/ajg.2009.329. Epub 2009 Jun 23.
PubMed 19550407Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med. 2006 Apr 20;354(16):1698-705. doi: 10.1056/NEJMoa055119.
PubMed 16625009Rerksuppaphol S, Rerksuppaphol L. Randomized study of ondansetron versus domperidone in the treatment of children with acute gastroenteritis. J Clin Med Res. 2013 Dec;5(6):460-6. doi: 10.4021/jocmr1500w. Epub 2013 Oct 12.
PubMed 24171058Das JK, Kumar R, Salam RA, Freedman S, Bhutta ZA. The effect of antiemetics in childhood gastroenteritis. BMC Public Health. 2013;13 Suppl 3(Suppl 3):S9. doi: 10.1186/1471-2458-13-S3-S9. Epub 2013 Sep 17.
PubMed 24564795Roslund G, Hepps TS, McQuillen KK. The role of oral ondansetron in children with vomiting as a result of acute gastritis/gastroenteritis who have failed oral rehydration therapy: a randomized controlled trial. Ann Emerg Med. 2008 Jul;52(1):22-29.e6. doi: 10.1016/j.annemergmed.2007.09.010. Epub 2007 Nov 19.
PubMed 18006189
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Ondansetron Versus Metoclopramide for Vomiting in Children With Acute Gastroenteritis: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT02619201
- Acronym / sponsor ID
- HGNAE-10
- Conditions
- Acute Gastroenteritis, Vomiting
- Keywords
- vomiting in children, ondansetron, metoclopramide, antiemetics
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Hospital General Naval de Alta Especialidad - Escuela Medico NavalOther government
- Study start
- Nov 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- Nov 2016 (estimated)
- First posted
- 2 Dec 2015 (estimated)
- 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.
Acute gastroenteritis (GEA) is a public health problem at present, the main cause of vomiting and consultation in emergencies in children under 5 years. Worldwide, there are about 2 million deaths per year due to gastroenteritis in children under 5 years.
In Mexico, the mortality rate by age in 2013, recorded 28 deaths per 100,000 boys and girls, in 2013 in our country 2.5 million children between 5 and 17 years engaged in an economic activity. The occupancy rate for the child population was 8.6: 11.4 for boys and 5.8 for girls.
NICE guidance gastroenteritis defined as a transient disorder caused by an enteric infection and characterized by a sudden onset of diarrhea with or without vomiting
Detailed description
It will be conducted a randomized controlled double-blinded study in the Emergency service of the Naval General Hospital of High Specialty in the Mexico City. The period of patient inclusion in the study is November 2015 to November 2016.
The selections of the patients are children between 1 and 5 years who come to the emergency room with symptoms of acute gastroenteritis with vomiting and intolerance of oral route.
Treatments were randomly assigned eligible patients on admission in the emergency department
The primary endpoint was evaluated at 15 minutes after treatment application:
- Treatment 1: Ondansetron was administered intravenous dose (0.15mg/kg/doses) Diluted in 20 ml saline and administered intravenously 5 minutes
- Treatment 2: Metoclopramide was administered intravenous dose (0.15mg/kg/doses) Diluted in 20 ml saline and administered intravenously 5 minutes
The administration of intravenous medications, will be held in the observation area of the emergency department of pediatrics under monitoring continuo vital signs during application and 15 minutes after treatment.
At 15 minutes after administration, the mouth with oral electrolyte begins by assessing your tolerance, 30 minutes to progress to the astringent diet.
It will follow up with patient assessment in the emergency department of pediatrics, 3 hours after having established the treatment, in order to corroborate the remission of vomiting, it is graduation of home otherwise he will enter hospital.
Primary objective Cumulative rate of cessation of vomiting
secondary objectives
- Compare the number of vomiting episodes with the administration of ondansetron vs metoclopramide
- Compare time duration in which the oral route is restarted.
- Compare hospital admission rate
- Describe adverse effects in both groups
Inclusion Criteria:
- Orally intolerance
- More than 2 vomiting in the last 24 hours
- Without antiemetic therapy within 24 hours of the clinical picture
- Patients with or without diarrhea
Exclusion Criteria:
- Previous abdominal surgery
- Suspected surgical abdominal
- vomiting bile
- Hypersensitivity to Ondansetron and Metoclopramide
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ondansetron | Experimental | Drug: OndansetronAn intravenous dose of ondansetron ( 0.15mg /kg / doses ) Diluted in 20 ml of saline and administer intravenously in 5 minutes |
| metoclopramide | Active comparator | Drug: metoclopramideAn intravenous dose of metoclopramide ( 0.15mg /kg / doses ) Diluted in 20 ml of saline and administer intravenously in 5 minutes |
Who may qualify
- Ages
- 1 year to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Orally intolerance
- More than 2 vomiting in the last 24 hours
- Without antiemetic therapy within 24 hours of the clinical picture
- Patients with or without diarrhea
Key exclusion criteria (4 listed)
- Previous abdominal surgery
- Suspected surgical abdominal
- Vomiting bile
- Hypersensitivity to Ondansetron and Metoclopramide
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 |
|---|---|---|
| OndansetronAlso: ODAn intravenous dose of ondansetron ( 0.15mg /kg / doses ) . | Drug | ondansetron |
| metoclopramideAlso: MTAn intravenous dose of metoclopramide ( 0.15mg /kg / doses ) . | Drug | metoclopramide |
Primary outcome
Cumulative rate of vomiting after cessation of drug administration
Time frame: 4 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2015.
- Background: PubMed 12211601Herikstad H, Yang S, Van Gilder TJ, Vugia D, Hadler J, Blake P, Deneen V, Shiferaw B, Angulo FJ. A population-based estimate of the burden of diarrhoeal illness in the United States: FoodNet, 1996-7. Epidemiol Infect. 2002 Aug;129(1):9-17. doi: 10.1017/s0950268801006628.
- Background: PubMed 18493225Guarino A, Albano F, Ashkenazi S, Gendrel D, Hoekstra JH, Shamir R, Szajewska H; ESPGHAN/ESPID Evidence-Based Guidelines for the Management of Acute Gastroenteritis in Children in Europe Expert Working Group. European Society for Paediatric Gastroenterology, Hepatology, and Nutrition/European Society for Paediatric Infectious Diseases evidence-based guidelines for the management of acute gastroenteritis in children in Europe: executive summary. J Pediatr Gastroenterol Nutr. 2008 May;46(5):619-21. doi: 10.1097/MPG.0b013e31816e219e. No abstract available.
- Background: PubMed 6689452Haque KN, al-Frayh A, el-Rifai R. Is it necessary to regraduate milk after acute gastroenteritis in children? Trop Geogr Med. 1983 Dec;35(4):369-73.
- Background: PubMed 22815462Carter B, Fedorowicz Z. Antiemetic treatment for acute gastroenteritis in children: an updated Cochrane systematic review with meta-analysis and mixed treatment comparison in a Bayesian framework. BMJ Open. 2012 Jul 19;2(4):e000622. doi: 10.1136/bmjopen-2011-000622. Print 2012.
- Background: PubMed 22132432National Collaborating Centre for Women's and Children's Health (UK). Diarrhoea and Vomiting Caused by Gastroenteritis: Diagnosis, Assessment and Management in Children Younger than 5 Years. London: RCOG Press; 2009 Apr. Available from http://www.ncbi.nlm.nih.gov/books/NBK63844/
- Background: PubMed 19550407Atia AN, Buchman AL. Oral rehydration solutions in non-cholera diarrhea: a review. Am J Gastroenterol. 2009 Oct;104(10):2596-604; quiz 2605. doi: 10.1038/ajg.2009.329. Epub 2009 Jun 23.
- Background: PubMed 16625009Freedman SB, Adler M, Seshadri R, Powell EC. Oral ondansetron for gastroenteritis in a pediatric emergency department. N Engl J Med. 2006 Apr 20;354(16):1698-705. doi: 10.1056/NEJMoa055119.
- Background: PubMed 24171058Rerksuppaphol S, Rerksuppaphol L. Randomized study of ondansetron versus domperidone in the treatment of children with acute gastroenteritis. J Clin Med Res. 2013 Dec;5(6):460-6. doi: 10.4021/jocmr1500w. Epub 2013 Oct 12.
- Background: PubMed 24564795Das JK, Kumar R, Salam RA, Freedman S, Bhutta ZA. The effect of antiemetics in childhood gastroenteritis. BMC Public Health. 2013;13 Suppl 3(Suppl 3):S9. doi: 10.1186/1471-2458-13-S3-S9. Epub 2013 Sep 17.
- Background: PubMed 18006189Roslund G, Hepps TS, McQuillen KK. The role of oral ondansetron in children with vomiting as a result of acute gastritis/gastroenteritis who have failed oral rehydration therapy: a randomized controlled trial. Ann Emerg Med. 2008 Jul;52(1):22-29.e6. doi: 10.1016/j.annemergmed.2007.09.010. Epub 2007 Nov 19.
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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.
Yaneth Miranda Tecuautzin, medicine principal investigator
Secretaria de Marina-Armada de México (Mexican Navy)
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ondansetron and metoclopramide in people with Acute Gastroenteritis and Vomiting, run by Hospital General Naval de Alta Especialidad - Escuela Medico Naval.
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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 2 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yaneth Miranda Tecuautzin, medicine (66 91 60 07 39, missin1821@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative rate of vomiting after cessation of drug administration (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02619201, which also lists 10 linked publications.
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 2 Dec 2015.