Trial record 10 of 160 for:    Open Studies | "Vomiting"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT02028910
First received: January 6, 2014
Last updated: January 22, 2014
Last verified: October 2012
  Purpose

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).


Condition Intervention Phase
Vomiting
Gastroenteritis
Drug: Ondansetron
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy of Ondansetron on Vomiting Due to Acute Gastroenteritis in Pediatric During Winter

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    Success will be defined by the absence of vomiting between 15 minutes and 4 hours after administration of study treatment.


Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 500
Study Start Date: January 2014
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ondansetron

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

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

Other Name: Ondansetron hydrochloride dihydrate
Placebo Comparator: placebo

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

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

Other Name: Ondansetron hydrochloride dihydrate

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.

  Eligibility

Ages Eligible for Study:   6 Months to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02028910

Contacts
Contact: Gajdos vincent, PHD 00331.45.37.42.72 vincent.gajdos@abc.aphp.fr

Locations
France
Vincent Gajdos Recruiting
Clamart, France, 92141
Contact: Vincent Gajdos, PHD    00 331.45.37.42.72    vincent.gajdos@abc.aphp.fr   
Principal Investigator: Vincent Gajdos, PHD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Gajdos Vincent, PHD APHP
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02028910     History of Changes
Other Study ID Numbers: P110105, 2011-004372- 11
Study First Received: January 6, 2014
Last Updated: January 22, 2014
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
gastroenteritis
pediatrics
vomiting

Additional relevant MeSH terms:
Vomiting
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Signs and Symptoms, Digestive
Signs and Symptoms
Ondansetron
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on July 23, 2014