GastroenteritisPhase 3NCT01257672
Symptomatic Treatment of Acute Gastroenteritis
A Phase 3 study testing Ondansetron and Domperidone in people with Gastroenteritis and Vomiting, run by IRCCS Burlo Garofolo at 15 sites in Italy.
Trial summary
Vomiting in children with acute gastroenteritis is a major factor of failure of oral rehydration therapy. Effective symptomatic treatment of vomiting would lead to an important reduction in the use of Intravenous Fluid Therapy. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Gastroenteritis, Vomiting, Acute Gastroenteritis
- What is being tested?
- Ondansetron and Domperidone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 356 participants
- Where
- 15 sitesItaly
- Study dates
- Jul 2011to Nov 2013
- 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 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- age from 1 to 6 years;
- presumptive clinical diagnosis of acute gastroenteritis in patients with vomiting, with or without diarrhoea;
- more than three episodes of non-bilious, non-bloody vomiting within the previous 24 hours;
Who cannot join
- treatment with antiemetics or antidiarrhoic drugs in the 6 hours prior to access to ED;
- underlying chronic diseases (eg, malignancy, gastroesophageal reflux, migraine, renal failure, hypoalbuminemia, liver disease);
- severe dehydration: weight loss>10% or standardized clinical dehydration score >=18 for children aged 12-24 months and >=16 for older children;
- known hypersensitivity to ondansetron or domperidone;
- previous enrolment in the study.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Italy15 sites
Dipartimento di Emergenza Pediatrica, Ospedale Giuseppe Moscati
Avellino
Dipartimento di Emergenza Pediatrica, P.O. Spedali Civili
Brescia
Divisione di Emergenza Pediatrica, Ospedale Pediatrico A. Meyer
Florence
Unità Operativa di Pediatria, Ospedale GB Morgagni
Forlì
Divisione di Emergenza Pediatrica, Istituto G. Gaslini
Genova
Dipartimento di Pediatria, Azienda Policlinico di Modena
Modena
Dipartimento di Emergenza Pediatrica, Azienda Ospedaliera - Università di Padova
Padova
Dipartimento di Pediatrica, Azienda Ospedaliera- Università di Parma
Parma
Dipartimento di Pediatrica, Ospedale di Macerata
Province of Macerata
Dipartimento di Emergenza Pediatrica, Ospedale Pediatrico IRCCS Bambino Gesú
Roma
Dipartimento di Emergenza Pediatrica, Ospedale Infantile Regina Margherita
Torino
Dipartimento di Pediatria, Ospedale di Treviso
Treviso
Dipartimento di Emergenza Pediatrica, Istituto per la l'Infanzia, IRCCS Burlo Garofolo
Trieste
Dipartimento di Pediatria, Ospedale Castelli
Verbania, Novara
Unità di Terapia Intensiva Pediatrica, Ospedale Civile Maggiore
Verona
About this study
Official title: Oral Ondansetron vs Domperidone for Symptomatic Treatment of Vomiting During Acute Gastroenteritis in Children: Multicentre Randomized Controlled Trial
Vomiting in children with acute gastroenteritis is a major factor of failure of oral rehydration therapy. Effective symptomatic treatment of vomiting would lead to an important reduction in the use of Intravenous Fluid Therapy. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking.
The aim of this multicentre, double-blind randomized controlled trial is to compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with acute gastroenteritis who have failed Oral Rehydration Therapy.
Read the detailed description
Vomiting in children with acute gastroenteritis (AG) is not only a direct cause of fluid loss but it is also a major factor of failure of oral rehydration therapy (ORT). Physicians who provide care to paediatric patients in the emergency department (ED) usually prescribe intravenous fluid therapy (IVT) for mild or moderate dehydration when vomiting is the major symptom. Thus, effective symptomatic treatment of vomiting would lead to an important reduction in the use of IVT and, consequently, of the duration of hospital stay and of frequency of hospital admission. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking.
The aim of this multicentre, double-blind randomized controlled trial conducted in paediatric Emergency Departments is to compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with AG who have failed Oral Rehydration Therapy.
The trial results would provide evidence on the efficacy of domperidone, which is largely used in clinical practice despite the lack of proper evaluation and a controversial safety profile, as compared to ondansetron, which is not yet authorized in Italy despite evidence supporting its efficacy in treating vomiting. The trial results would contribute to a reduction in the use of IVT and, consequently, in hospital admissions in children with AG. The design of this RCT, which closely reflect current clinical practice in EDs, will allow immediate transferability of results
- Conditions
- Gastroenteritis, Vomiting, Acute Gastroenteritis
- Being tested
- Ondansetron, Domperidone, placebo
- Keywords
- acute gastroenteritis, vomiting, ondansetron, domperidon, symptomatic treatment
- Medical subject headings
- Gastroenteritis, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called zofran
ondansetron syrup (0,15 mg/Kg of body weight)
DomperidoneDrug
Also called Motilium
domperidone syrup (0,5 mg/Kg of body weight)
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| ondansetron | Experimental | ondansetron, syrup, 0,15 mg/Kg of body weight, 1 dose Receives: Drug: Ondansetron |
| domperidon | Active comparator | domperidone, syrup, 0,5 mg/Kg of body weight, one dose Receives: Drug: Domperidone |
| placebo | Placebo comparator | placebo, syrup, one dose Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients needing nasogastric or intravenous rehydration after symptomatic oral treatment failure, defined as vomiting or fluid refusal after the second attempt of ORT.
Measured: 6 hours
Secondary outcomes (5)
Percentage of subjects needing hospital admission for the same illness;
Measured: 48 hours
Percentage of subjects needing observation stay for more than 6 hours for the same illness
Measured: 48 hours
Total emesis duration in the 3 allocation groups;
Measured: 48 hours
Number of episodes of vomiting in the 3 treatment groups during the follow-up period
Measured: 48 hours
Percentage of subjects presenting adverse events
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2010 (estimated)
- Study startJul 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS Burlo Garofolo
- Sponsor type
- University, hospital or other
- Collaborators
- Mario Negri Institute for Pharmacological Research, Agenzia Italiana del Farmaco
- Responsible party
- Principal investigator, Ronfani Luca, IRCCS Burlo Garofolo
- Investigators
- Federico Marchetti, MD, Study chair, IRCCS Burlo GarofoloMaurizio Bonati, MD, Study director, Mario Negri Institute for Pharmacological Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257672
- Sponsor's protocol ID
- FARM8E53XM
- Other IDs
- 2010-019787-36
- Status last verified
- Apr 2014
- First submitted
- 9 Dec 2010
- Last updated
- 21 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marchetti F, Maestro A, Rovere F, Zanon D, Arrighini A, Bertolani P, Biban P, Da Dalt L, Di Pietro P, Renna S, Guala A, Mannelli F, Pazzaglia A, Messi G, Perri F, Reale A, Urbino AF, Valletta E, Vitale A, Zangardi T, Tondelli MT, Clavenna A, Bonati M, Ronfani L. Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial. BMC Pediatr. 2011 Feb 10;11:15. doi: 10.1186/1471-2431-11-15.
PubMed 21310051
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Ondansetron vs Domperidone for Symptomatic Treatment of Vomiting During Acute Gastroenteritis in Children: Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01257672
- Acronym / sponsor ID
- FARM8E53XM
- Conditions
- Gastroenteritis, Vomiting, Acute Gastroenteritis
- Keywords
- acute gastroenteritis, vomiting, ondansetron, domperidon, symptomatic treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- IRCCS Burlo GarofoloUniversity, hospital or other
- Collaborators
- Mario Negri Institute for Pharmacological Research, Agenzia Italiana del Farmaco
- Study start
- Jul 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 10 Dec 2010 (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.
Vomiting in children with acute gastroenteritis is a major factor of failure of oral rehydration therapy. Effective symptomatic treatment of vomiting would lead to an important reduction in the use of Intravenous Fluid Therapy. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking.
The aim of this multicentre, double-blind randomized controlled trial is to compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with acute gastroenteritis who have failed Oral Rehydration Therapy.
Detailed description
Vomiting in children with acute gastroenteritis (AG) is not only a direct cause of fluid loss but it is also a major factor of failure of oral rehydration therapy (ORT). Physicians who provide care to paediatric patients in the emergency department (ED) usually prescribe intravenous fluid therapy (IVT) for mild or moderate dehydration when vomiting is the major symptom. Thus, effective symptomatic treatment of vomiting would lead to an important reduction in the use of IVT and, consequently, of the duration of hospital stay and of frequency of hospital admission. Available evidence on symptomatic treatment of vomiting shows the efficacy of the most recently registered molecule (ondansetron) but a proper evaluation of antiemetics drugs largely used in clinical practice, such as domperidone, is lacking.
The aim of this multicentre, double-blind randomized controlled trial conducted in paediatric Emergency Departments is to compare the efficacy of ondansetron and domperidone for the symptomatic treatment of vomiting in children with AG who have failed Oral Rehydration Therapy.
The trial results would provide evidence on the efficacy of domperidone, which is largely used in clinical practice despite the lack of proper evaluation and a controversial safety profile, as compared to ondansetron, which is not yet authorized in Italy despite evidence supporting its efficacy in treating vomiting. The trial results would contribute to a reduction in the use of IVT and, consequently, in hospital admissions in children with AG. The design of this RCT, which closely reflect current clinical practice in EDs, will allow immediate transferability of results
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ondansetron | Experimental | Drug: Ondansetronondansetron, syrup, 0,15 mg/Kg of body weight, 1 dose |
| domperidon | Active comparator | Drug: Domperidonedomperidone, syrup, 0,5 mg/Kg of body weight, one dose |
| placebo | Placebo comparator | Drug: placeboplacebo, syrup, one dose |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- age from 1 to 6 years;
- presumptive clinical diagnosis of acute gastroenteritis in patients with vomiting, with or without diarrhoea;
- more than three episodes of non-bilious, non-bloody vomiting within the previous 24 hours;
Key exclusion criteria (5 listed)
- treatment with antiemetics or antidiarrhoic drugs in the 6 hours prior to access to ED;
- underlying chronic diseases (eg, malignancy, gastroesophageal reflux, migraine, renal failure, hypoalbuminemia, liver disease);
- severe dehydration: weight loss>10% or standardized clinical dehydration score >=18 for children aged 12-24 months and >=16 for older children;
- known hypersensitivity to ondansetron or domperidone;
- previous enrolment in the study.
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: zofranondansetron syrup (0,15 mg/Kg of body weight) | Drug | ondansetron |
| DomperidoneAlso: Motiliumdomperidone syrup (0,5 mg/Kg of body weight) | Drug | domperidon |
| placeboplacebo | Drug | placebo |
Primary outcome
Percentage of patients needing nasogastric or intravenous rehydration after symptomatic oral treatment failure, defined as vomiting or fluid refusal after the second attempt of ORT.
Time frame: 6 hours
5 secondary outcomes
Percentage of subjects needing hospital admission for the same illness;
Time frame: 48 hours
Percentage of subjects needing observation stay for more than 6 hours for the same illness
Time frame: 48 hours
Total emesis duration in the 3 allocation groups;
Time frame: 48 hours
Number of episodes of vomiting in the 3 treatment groups during the follow-up period
Time frame: 48 hours
Percentage of subjects presenting adverse events
Time frame: 48 hours
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 21 Apr 2014.
- Background: PubMed 21310051Marchetti F, Maestro A, Rovere F, Zanon D, Arrighini A, Bertolani P, Biban P, Da Dalt L, Di Pietro P, Renna S, Guala A, Mannelli F, Pazzaglia A, Messi G, Perri F, Reale A, Urbino AF, Valletta E, Vitale A, Zangardi T, Tondelli MT, Clavenna A, Bonati M, Ronfani L. Oral ondansetron versus domperidone for symptomatic treatment of vomiting during acute gastroenteritis in children: multicentre randomized controlled trial. BMC Pediatr. 2011 Feb 10;11:15. doi: 10.1186/1471-2431-11-15.
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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.
Federico Marchetti, MD study chair
IRCCS Burlo Garofolo
Maurizio Bonati, MD study director
Mario Negri Institute for Pharmacological Research
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ondansetron and Domperidone in people with Gastroenteritis and Vomiting, run by IRCCS Burlo Garofolo at 15 sites in Italy.
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 3 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 21 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Italy. 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. Some participants in this study may receive a placebo. 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?
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?
Percentage of patients needing nasogastric or intravenous rehydration after symptomatic oral treatment failure, defined as vomiting or fluid refusal after the second attempt of ORT. (time frame: 6 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 NCT01257672, which also lists 1 linked publication.
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 21 Apr 2014.