Survey of treatment with ondansetron for pediatric acute gastroenteritis

JRCT ID: jRCTs031230305

Registered date:22/08/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Acute gastroenteritis
• Date of first enrollment: 04/09/2023
• Target sample size: 100
• Study type: Interventional

Intervention(s)

Ondansetron OD Film is administered according to the following dosage and administration.
Dosage and administration: Oral
Dosage: 1 mg (8 kg or more but less than 10 kg), 2 mg (10 kg or more but less than 20 kg), 3 mg (20 kg or more but less than 30 kg), 4 mg (30 kg or more)

Outcome(s)

• Primary Outcome: Percentage of cases with resolution of emesis up to 4 hours after administration

Secondary Outcome

Percentage of patients with resolution of vomiting (8 and 24 hours after administration)
Duration of vomiting (time from administration to last vomiting)
Frequency of vomiting (4 ,8, and 24 hours after administration)
Percentage of cases requiring intravenous fluids (4 ,8, and 24 hours after administration)
Percentage of patients requiring hospitalization (4 ,8, and 24 hours after administration)
Numerical Rating Scale (NRS) for nausea (before, 4 hours after, 8 hours after, and 24 hours after study drug administration) (6 years and older)
Amount of water consumed (4 ,8, and 24 hours after administration)

Subgroup analyses will be conducted for all the above items in the case group with Clinical Dehydration Score is 1 and over and in each group by dose of study drug.

Safety Assessment
Percentage of causally related adverse events
Percentage of all adverse events

Subgroup analyses will be conducted for all the above items in each group by dose of study drug.

Evaluation of drug compliance by observation by a healthcare provider
Presence or absence and number of vomiting episodes from the administration of study drug to 2 minutes after administration
Taste survey for the patient (age 6 years and older)
Questionnaire survey for parents
Questionnaire survey for healthcare providers

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: < 15age old
• Gender: Both

Include criteria

(1) Clinically diagnosed with acute gastroenteritis
(2) The patient has vomited at least twice within 24 hours
(3) The patient has vomited at least once within 4 hours
(4) Between 6 months and 15 years of age
(5) Written consent has been obtained
(6) 7 years of age or older has received ascent written explanation whenever possible

Exclude criteria

(1) Patients with bilious or bloody vomiting
(2) Patient with disturbance of consciousness
(3) Patient with severe dehydration or hypoglycemia requiring rapid infusion
(4) Patients who have received antiemetic drugs within 72 hours
(5) Patients whose weight is less than 8 kg
(6) Patients with underlying disease*
(7) Patients with a history of abdominal surgery
(8) Patients with an allergy to ondansetron
(9) Pregnant women or women who may be pregnant
(10) Patients with a history of epilepsy
(11) Patients who have been previously enrolled in this study.
(12) Patients who have been judged to be inappropriate to participate in the study.

Related Information

• Primary Sponsor: Kishibe Shun
• Secondary Sponsor: Ikegawa Kento,Morikawa Yoshihiko
• Source(s) of Monetary Support: MIYARISAN PHARMACEUTICAL CO. LTD.,Tokyo Metropolitan Children's Medical Center