Olanzapine for Prevention of Vomiting in Children and Adolescents Receiving Highly Emetogenic Chemotherapy
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age5-18
SponsorShanghai Children's Medical Center
About this trial
Breakthrough chemotherapy-induced vomiting (CIV) is defined as CIV occurring after adequate antiemetic prophylaxis. Olanzapine is recommended for the treatment of breakthrough CIV in children, without adequate evidence. We conducted an open-label, single-center, phase 3 randomized controlled trial comparing the safety and efficacy of olanzapine and metoclopramide for treating breakthrough CIV.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Children with history of allergy to olanzapine or metoclopramide; patient with renal failure, congestive heart failure, or any uncontrolled disease except for malignancy; serum creatinine more than upper limit of normal (ULN) for age; serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) four times the ULN for age and serum bilirubin 1.5 times ULN for age; patient with history of central nervous system disease including brain metastasis, seizure disorder, or psychosis; patients on treatment with other antipsychotic agents such as risperidone, quetiapine, clozapine, or phenothiazine.
Trial design
Design model
Parallel
Treatments tested in this trial
Olanzapine Tablets
DrugOral olanzapine tablets
Placebo
DrugOral placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Olanzapine groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
the CR rate for vomiting in the first 72 hours
The primary endpoint was the CR rate for vomiting in the first 72 hours of the initiation of olanzapine .
Time frame
in the first 72 hours of the initiation of olanzapineSecondary outcomes
1
the CR rate for nausea in the first 72 hours of the initiation of olanzapine
The secondary endpoint was the CR rate for nausea in the first 72 hours of the initiation of olanzapine
Time frame
in the first 72 hours of the initiation of olanzapineSponsors and contacts
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Source ClinicalTrials.gov
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