Efficacy of Ondansetron on Vomiting Due to Acute Gastroenteritis in Pediatric During Winter

NCT02028910 | Terminated Phase 3

• 2 other identifiers: P1101052011-004372- 11
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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 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).

Conditions

Vomiting; Gastroenteritis

Keywords

gastroenteritis; pediatrics; vomiting

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  These criteria will be assessed within 7 days after the departure of emergencies.

Study Arms (2)

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.

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.

Drug: Ondansetron

Interventions

Ondansetron DRUG

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

Also known as: Ondansetron hydrochloride dihydrate

Ondansetron; placebo

Eligibility Criteria

• Age: 6 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Vincent Gajdos

Clamart, Clamart, 92141, France

Location

MeSH Terms

Conditions

Vomiting; Gastroenteritis

Interventions

Ondansetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Study Officials

• Gajdos Vincent, PHD

  APHP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2014
• First Posted: January 7, 2014
• Study Start: January 1, 2014
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: December 4, 2014

Record last verified: 2012-10

Locations

FR (1)