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
Qualifiers
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
Treatments tested in this trial
- Olanzapine Tablets
- Placebo
Treatment groups
100 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov