VomitingPhase 3OndangapiNCT02028910
Efficacy of Ondansetron on Vomiting Due to Acute Gastroenteritis in Pediatric During Winter
A Phase 3 study testing Ondansetron in people with Vomiting and Gastroenteritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
Acute gastroenteritis is a common disease especially in children. With bronchiolitis and influenza, she participated widely in weight of winter epidemics that causes problems every year our health care system, particularly in the pediatric emergency and inpatient since they are the second leading cause of… Read more about this study
- Who is it for?
- Ages 6 months to 15 years
- Conditions the study is for
- Vomiting, Gastroenteritis
- What is being tested?
- Ondansetron
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to Oct 2014
- 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 6 months to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age ≥ 6 months and ≤ 15 years
- Children who had more than 3 non bilious vomiting and bloodless within 12 hours before emergency department visit
- Children whose parents agree to be contacted by phone
- Completion of a medical examination (to communicate results to the patient)
- Informed consent and written / holder (s) of parental authority (s) present
Who cannot join
- Children with a congenital long QT (ECG prior to inclusion required)
- Children with and / or current symptomatic cardiovascular
- Children with a shock
- Children with a concomitant surgical pathology
- Notion of head trauma within 3 days before the emergency department visit
- Suspicion of intracranial hypertension (intracranial hypertension)
Show all 21Show fewer
- Children who underwent surgery within 14 days before the emergency department visit
- Suspected acute can be alone responsible for vomiting, such as: discovery of diabetes, acute adrenal insufficiency, including acute neurological acute meningitis, acute respiratory illness with cough emetogenic acute otitis media, acute pyelonephritis, .. . .
- Child tracking to one of the following chronic conditions treated:
- heart o
- pulmonary
- digestive (except gastroesophageal reflux)
- kidney
- hematologic (immunosuppression / SCD)
- endocrine / metabolic (diabetes, adrenal insufficiency)
- Phenylketonuria
- Allergy or intolerance to ondansetron or any of the ingredients of the syrup
- Children who received treatment with an anti-emetic (Primperan ®, Motilium ®, vogalene ®) within 24 hours before emergency department visit
- Pregnancy or breastfeeding
- No affiliation to a social security scheme (beneficiary or assignee)
- Family not speaking
Trial locations and contacts
1 site in 1 country.
About this study
Acute gastroenteritis is a common disease especially in children. With bronchiolitis and influenza, she participated widely in weight of winter epidemics that causes problems every year our health care system, particularly in the pediatric emergency and inpatient since they are the second leading cause of hospitalization in children. The main symptoms of viral acute gastroenteritis are diarrhea and vomiting which exposes children to the risk of sometimes severe dehydration, the most common cause of hospitalization. There is no specific treatment for these infections. At most, there is a vaccine against severe rotavirus diarrhea (Rotarix ® and RotaTeq ®), but does not yet official recommendations to use in France. The treatment of acute gastroenteritis virus is symptomatic and is generally based on the use of oral rehydration solutions (ORS) whose administration is limited by the frequent presence of vomiting. Until now, no treatment has demonstrated its effectiveness on vomiting due to acute gastroenteritis virus in children. Conventional anti-emetics, widely prescribed, are ineffective in practice, very few studies in this indication and encumbered side effects. Several drugs have long been used in children to fight against severe vomiting associated with the administration of anti-cancer chemotherapy, such as granisetron (Kytril ®) and ondansetron (Zofren ®). The mechanism of action of these molecules is well known. They act both on the enteric nervous system by blocking serotonin receptors. Several placebo-controlled trials suggest that ondansetron is effective in reducing the number of vomiting in children emergency consultant for acute gastroenteritis. However, the method used in these tests and the number of children enrolled has not yet demonstrated the efficacy of ondansetron on the number of admissions, the number of emergency and return the cost / benefit ratio of this treatment. In addition, several studies reported the occurrence of watery stools more frequently in children treated with the placebo group.
Evidence that ondansetron is well tolerated and effective for reducing the severity of vomiting during acute gastroenteritis pediatrics winter could support the use of this treatment in routine pediatric emergencies.
This study is a clinical trial, multicenter, controlled versus placebo whose main objective is to evaluate the efficacy of ondansetron to decrease the intensity of vomiting in children with acute gastroenteritis during winter emergencies Upon arrival to the emergency room after signing. Consent, an ECG is performed in eligible patients. Children meet all the criteria for inclusion and non-inclusion receive, at random, one of two treatments: ondansetron (active) or placebo. The study does not alter the usual care of the child to the emergency room. After passing emergency, patients will be followed in the study for 8 days, through a phone call home to J3 and J7. The total duration of patient participation in the study is 8 days, including 4 hours emergencies (usual transit time to emergencies).
Read the detailed description
Acute gastroenteritis is a common disease especially in children. With bronchiolitis and influenza, she participated widely in weight of winter epidemics that causes problems every year our health care system, particularly in the pediatric emergency and inpatient since they are the second leading cause of hospitalization in children. The main symptoms of viral acute gastroenteritis are diarrhea and vomiting which exposes children to the risk of sometimes severe dehydration, the most common cause of hospitalization. There is no specific treatment for these infections. At most, there is a vaccine against severe rotavirus diarrhea (Rotarix ® and RotaTeq ®), but does not yet official recommendations to use in France. The treatment of acute gastroenteritis virus is symptomatic and is generally based on the use of oral rehydration solutions (ORS) whose administration is limited by the frequent presence of vomiting. Until now, no treatment has demonstrated its effectiveness on vomiting due to acute gastroenteritis virus in children. Conventional anti-emetics, widely prescribed, are ineffective in practice, very few studies in this indication and encumbered side effects. Several drugs have long been used in children to fight against severe vomiting associated with the administration of anti-cancer chemotherapy, such as granisetron (Kytril ®) and ondansetron (Zofren ®). The mechanism of action of these molecules is well known. They act both on the enteric nervous system by blocking serotonin receptors. Several placebo-controlled trials suggest that ondansetron is effective in reducing the number of vomiting in children emergency consultant for acute gastroenteritis. However, the method used in these tests and the number of children enrolled has not yet demonstrated the efficacy of ondansetron on the number of admissions, the number of emergency and return the cost / benefit ratio of this treatment. In addition, several studies reported the occurrence of watery stools more frequently in children treated with the placebo group.
Evidence that ondansetron is well tolerated and effective for reducing the severity of vomiting during acute gastroenteritis pediatrics winter could support the use of this treatment in routine pediatric emergencies.
This study is a clinical trial, multicenter, controlled versus placebo whose main objective is to evaluate the efficacy of ondansetron to decrease the intensity of vomiting in children with acute gastroenteritis during winter emergencies Upon arrival to the emergency room after signing. Consent, an ECG is performed in eligible patients. Children meet all the criteria for inclusion and non-inclusion receive, at random, one of two treatments: ondansetron (active) or placebo. The study does not alter the usual care of the child to the emergency room. After passing emergency, patients will be followed in the study for 8 days, through a phone call home to J3 and J7. The total duration of patient participation in the study is 8 days, including 4 hours emergencies (usual transit time to emergencies).
Outside the study drug administration, it will be in the framework of the research:
- An electrocardiogram inclusion
- A stool specimen
- A fill two questionnaires, one of which during the passage of emergency and the other during two phone calls within 7 days after the departure of emergencies.
This will be done in addition to the balance necessary to support the patient.
- Conditions
- Vomiting, Gastroenteritis
- Being tested
- Ondansetron
- Keywords
- gastroenteritis, pediatrics, vomiting
- Medical subject headings
- Vomiting, Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Ondansetron hydrochloride dihydrate
The treatment is administered orally in a single dose of 2.5 ml = 2 mg per 5 kg weight of the child, not to exceed the maximum dose of 10mg. A second dose, the same dose is given back if the child vomits within 15 minutes after the first administration.
The bottle contains at least 2 doses of up to 10 mg for a second dose can be given back in case of vomiting within 15 minutes after the first dose in children weighing more than 25 kg.
The dosage should be adjusted according to the weight of the child
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | The treatments in the form of cases numbered 1 vial of 50 ml of ondansetron 0.8 mg / ml oral solution + 5 ml syringe for oral administration.
No special storage conditions ondansetron syrup.The treatment is administered orally as a single dose of 2.5 ml = 2 mg per 5 kg weight of the child, not to exceed a maximum dose of 10mg. A second outlet, at the same dose, is restored if the child vomits within 15 minutes after the first administration. Receives: Drug: Ondansetron |
| placebo | Placebo comparator | The treatments in the form of cases numbered 1 vial of 50 ml of placebo 0.8 mg / ml oral solution + 5 ml syringe for oral administration.
No special storage conditions placebo syrup.The treatment is administered orally as a single dose of 2.5 ml = 2 mg per 5 kg weight of the child, not to exceed a maximum dose of 10mg. A second outlet, at the same dose, is restored if the child vomits within 15 minutes after the first administration. Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success will be defined by the absence of vomiting between 15 minutes and 4 hours after administration of study treatment.
Success will be defined by the absence of vomiting between 15 minutes and 4 hours after administration of study treatment.
Measured: the absence of vomiting between 15 minutes and 4 hours after administration of study treatment.
Secondary outcomes (1)
Hospital admissions for acute gastroenteritis, intravenous infusion for rehydration, return emergency department visit, severity and duration of diarrhea and vomiting. Treatment safety will also be assessed. These criteria will be assessed within 7 days
Hospital admissions for acute gastroenteritis, intravenous infusion for rehydration, return emergency department visit, severity and duration of diarrhea and vomiting. Treatment safety will also be assessed.
These criteria will be assessed within 7 days after the departure of emergencies.
Measured: These criteria will be assessed within 7 days after the departure of emergencies.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2014 (estimated)
- Study startJan 2014
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VomitingStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gajdos Vincent, PHD, Principal investigator, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02028910
- Sponsor's protocol ID
- P110105
- Other IDs
- 2011-004372- 11
- Acronym
- Ondangapi
- Status last verified
- Oct 2012
- First submitted
- 6 Jan 2014
- Last updated
- 4 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Ondansetron on Vomiting Due to Acute Gastroenteritis in Pediatric During Winter
- ClinicalTrials.gov ID
- NCT02028910
- Acronym / sponsor ID
- Ondangapi / P110105
- Conditions
- Vomiting, Gastroenteritis
- Keywords
- gastroenteritis, pediatrics, vomiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 7 Jan 2014 (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 is a common disease especially in children. With bronchiolitis and influenza, she participated widely in weight of winter epidemics that causes problems every year our health care system, particularly in the pediatric emergency and inpatient since they are the second leading cause of hospitalization in children. The main symptoms of viral acute gastroenteritis are diarrhea and vomiting which exposes children to the risk of sometimes severe dehydration, the most common cause of hospitalization. There is no specific treatment for these infections. At most, there is a vaccine against severe rotavirus diarrhea (Rotarix ® and RotaTeq ®), but does not yet official recommendations to use in France. The treatment of acute gastroenteritis virus is symptomatic and is generally based on the use of oral rehydration solutions (ORS) whose administration is limited by the frequent presence of vomiting. Until now, no treatment has demonstrated its effectiveness on vomiting due to acute gastroenteritis virus in children. Conventional anti-emetics, widely prescribed, are ineffective in practice, very few studies in this indication and encumbered side effects. Several drugs have long been used in children to fight against severe vomiting associated with the administration of anti-cancer chemotherapy, such as granisetron (Kytril ®) and ondansetron (Zofren ®). The mechanism of action of these molecules is well known. They act both on the enteric nervous system by blocking serotonin receptors. Several placebo-controlled trials suggest that ondansetron is effective in reducing the number of vomiting in children emergency consultant for acute gastroenteritis. However, the method used in these tests and the number of children enrolled has not yet demonstrated the efficacy of ondansetron on the number of admissions, the number of emergency and return the cost / benefit ratio of this treatment. In addition, several studies reported the occurrence of watery stools more frequently in children treated with the placebo group.
Evidence that ondansetron is well tolerated and effective for reducing the severity of vomiting during acute gastroenteritis pediatrics winter could support the use of this treatment in routine pediatric emergencies.
This study is a clinical trial, multicenter, controlled versus placebo whose main objective is to evaluate the efficacy of ondansetron to decrease the intensity of vomiting in children with acute gastroenteritis during winter emergencies Upon arrival to the emergency room after signing. Consent, an ECG is performed in eligible patients. Children meet all the criteria for inclusion and non-inclusion receive, at random, one of two treatments: ondansetron (active) or placebo. The study does not alter the usual care of the child to the emergency room. After passing emergency, patients will be followed in the study for 8 days, through a phone call home to J3 and J7. The total duration of patient participation in the study is 8 days, including 4 hours emergencies (usual transit time to emergencies).
Detailed description
Acute gastroenteritis is a common disease especially in children. With bronchiolitis and influenza, she participated widely in weight of winter epidemics that causes problems every year our health care system, particularly in the pediatric emergency and inpatient since they are the second leading cause of hospitalization in children. The main symptoms of viral acute gastroenteritis are diarrhea and vomiting which exposes children to the risk of sometimes severe dehydration, the most common cause of hospitalization. There is no specific treatment for these infections. At most, there is a vaccine against severe rotavirus diarrhea (Rotarix ® and RotaTeq ®), but does not yet official recommendations to use in France. The treatment of acute gastroenteritis virus is symptomatic and is generally based on the use of oral rehydration solutions (ORS) whose administration is limited by the frequent presence of vomiting. Until now, no treatment has demonstrated its effectiveness on vomiting due to acute gastroenteritis virus in children. Conventional anti-emetics, widely prescribed, are ineffective in practice, very few studies in this indication and encumbered side effects. Several drugs have long been used in children to fight against severe vomiting associated with the administration of anti-cancer chemotherapy, such as granisetron (Kytril ®) and ondansetron (Zofren ®). The mechanism of action of these molecules is well known. They act both on the enteric nervous system by blocking serotonin receptors. Several placebo-controlled trials suggest that ondansetron is effective in reducing the number of vomiting in children emergency consultant for acute gastroenteritis. However, the method used in these tests and the number of children enrolled has not yet demonstrated the efficacy of ondansetron on the number of admissions, the number of emergency and return the cost / benefit ratio of this treatment. In addition, several studies reported the occurrence of watery stools more frequently in children treated with the placebo group.
Evidence that ondansetron is well tolerated and effective for reducing the severity of vomiting during acute gastroenteritis pediatrics winter could support the use of this treatment in routine pediatric emergencies.
This study is a clinical trial, multicenter, controlled versus placebo whose main objective is to evaluate the efficacy of ondansetron to decrease the intensity of vomiting in children with acute gastroenteritis during winter emergencies Upon arrival to the emergency room after signing. Consent, an ECG is performed in eligible patients. Children meet all the criteria for inclusion and non-inclusion receive, at random, one of two treatments: ondansetron (active) or placebo. The study does not alter the usual care of the child to the emergency room. After passing emergency, patients will be followed in the study for 8 days, through a phone call home to J3 and J7. The total duration of patient participation in the study is 8 days, including 4 hours emergencies (usual transit time to emergencies).
Outside the study drug administration, it will be in the framework of the research:
- An electrocardiogram inclusion
- A stool specimen
- A fill two questionnaires, one of which during the passage of emergency and the other during two phone calls within 7 days after the departure of emergencies.
This will be done in addition to the balance necessary to support the patient.
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: OndansetronThe treatments in the form of cases numbered 1 vial of 50 ml of ondansetron 0.8 mg / ml oral solution + 5 ml syringe for oral administration. No special storage conditions ondansetron syrup.The treatment is administered orally as a single dose of 2.5 ml = 2 mg per 5 kg weight of the child, not to exceed a maximum dose of 10mg. A second outlet, at the same dose, is restored if the child vomits within 15 minutes after the first administration. |
| placebo | Placebo comparator | Drug: OndansetronThe treatments in the form of cases numbered 1 vial of 50 ml of placebo 0.8 mg / ml oral solution + 5 ml syringe for oral administration. No special storage conditions placebo syrup.The treatment is administered orally as a single dose of 2.5 ml = 2 mg per 5 kg weight of the child, not to exceed a maximum dose of 10mg. A second outlet, at the same dose, is restored if the child vomits within 15 minutes after the first administration. |
Who may qualify
- Ages
- 6 months to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age ≥ 6 months and ≤ 15 years
- Children who had more than 3 non bilious vomiting and bloodless within 12 hours before emergency department visit
- Children whose parents agree to be contacted by phone
- Completion of a medical examination (to communicate results to the patient)
- Informed consent and written / holder (s) of parental authority (s) present
Key exclusion criteria (21 listed)
- Children with a congenital long QT (ECG prior to inclusion required)
- Children with and / or current symptomatic cardiovascular
- Children with a shock
- Children with a concomitant surgical pathology
- Notion of head trauma within 3 days before the emergency department visit
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: Ondansetron hydrochloride dihydrateThe treatment is administered orally in a single dose of 2.5 ml = 2 mg per 5 kg weight of the child, not to exceed the maximum dose of 10mg. A second dose, the same dose is given back if the child vomits within 15 minutes after the first administration. The bottle contains at least 2 doses of up to 10 mg for a second dose can be given back in case of vomiting within 15 minutes after the first dose in children weighing more than 25 kg. The dosage should be adjusted according to the weight of the child | Drug | Ondansetron, placebo |
Primary outcome
Success will be defined by the absence of vomiting between 15 minutes and 4 hours after administration of study treatment.
Time frame: the absence of vomiting between 15 minutes and 4 hours after administration of study treatment.
Success will be defined by the absence of vomiting between 15 minutes and 4 hours after administration of study treatment.
1 secondary outcome
Hospital admissions for acute gastroenteritis, intravenous infusion for rehydration, return emergency department visit, severity and duration of diarrhea and vomiting. Treatment safety will also be assessed. These criteria will be assessed within 7 days
Time frame: These criteria will be assessed within 7 days after the departure of emergencies.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2014.
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Nausea, Vomiting
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.
Gajdos Vincent, PHD principal investigator
APHP
1 site 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 in people with Vomiting and Gastroenteritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 21 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: stopped early, as of the sponsor's last update on 4 Dec 2014. 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 France. 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 was stopped early. Results are not available in the source record.
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?
Success will be defined by the absence of vomiting between 15 minutes and 4 hours after administration of study treatment. (time frame: the absence of vomiting between 15 minutes and 4 hours after administration of study treatment.). 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 4 Dec 2014.