NCT05346731 (OZONE-V) is a Phase 3 clinical trial of Ondansetron in Chemotherapy-induced Nausea and Vomiting, sponsored by Federal Research Institute of Pediatric Hematology, Oncology and Immunology.

What drugs are being tested in NCT05346731?

Interventions in NCT05346731: Ondansetron, Dexamethasone, Aprepitant, Olanzapine.

What condition does NCT05346731 study?

NCT05346731 studies Chemotherapy-induced Nausea and Vomiting.

Is NCT05346731 still recruiting?

NCT05346731 is currently status unknown. Last updated 27 July 2022.

Last reviewed 2022-07-27 · How we verify

NCT05346731: OZONE-V

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Efficacy and Safety Addition of Low Dose Olanzapine to the Standard Prophylaxis of Nausea and Vomiting Induced by Highly-emetogenic Chemotherapy in Children and Adolescents (OZONE-V)

Status unknown Phase 3 Last updated 27 July 2022

What this trial tests

Phase 3 trial testing Ondansetron in Chemotherapy-induced Nausea and Vomiting in 210 participants. Status unknown.

Timeline

1 April 2022

Primary endpoint
1 March 2024

1 August 2024

Quick facts

Lead sponsor	Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Phase	Phase 3
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	210
Start date	1 April 2022
Primary completion	1 March 2024
Estimated completion	1 August 2024
Sites	1 location across Russia

Drugs / interventions tested

Ondansetron (ondansetron) — full drug profile →
Dexamethasone (dexamethasone) — full drug profile →
Aprepitant (APREPITANT) — full drug profile →
Olanzapine (olanzapine) — full drug profile →

Conditions studied

Chemotherapy-induced Nausea and Vomiting — all drugs for Chemotherapy-induced Nausea and Vomiting →

Sponsor

Federal Research Institute of Pediatric Hematology, Oncology and Immunology

Who can join

Adults 5 to 18, any sex, with Chemotherapy-induced Nausea and Vomiting. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Complete control of vomiting
Time frame: up to 21 days
proportion of patients who did not have episodes of vomiting and/or use of additional antiemetic drugs (rescue therapy) during the chemotherapy cycle and within 120 hours after its completion
Patient preference
Time frame: up to 42 days
Proportion of patients who, after crossover, chose to continue treatment with an experimental regimen including olanzapine
Adverce events
Time frame: up to 42 days
Percentage of patients with grade 3-4 adverse events according to CTCAE v. 5.0. \[Time frame: day(s) of chemotherapy administration and 120 hours after chemotherapy administration\]

Sponsor's own description

Chemotherapy-induced nausea and vomiting continues to be a significant problem in children and adolescents. Standard antiemetic therapy, including a 5-HT3 antagonist, aprepitant, and a corticosteroid, achieves complete control in less than 50% of patients. Studies have shown that the addition of large doses of olanzapine improves control, including in children and adolescents. However, olanzapine has not yet been included in standard recommendations in the pediatric population. Studies in adults indicate that the dose of the drug can be halved without loss of effectiveness and with a decrease in toxicity. This open-label, randomized, phase III trial evaluates the efficacy and safety of adding low-dose olanzapine to standard prevention of nausea and vomiting induced by highly emetogenic chemotherapy in children and adolescents.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Ondansetron

Trials testing the same drug.

NCT06861010 — Evaluating the Safety and Efficacy of Ondansetron in the Prevention of Post Endoscopic Retrograde Cholangiopancreatograp · Phase 3 · recruiting
NCT07310563 — A Trial to Evaluate Interactions Between Antiemetic Medication and AMG 133 in Participants Living With Overweight or Obe · Phase 1 · completed
NCT06898268 — Efficacy and Safety of Ondansetron Versus Metaclopromide Treatment in Infants With Gastro Oesophageal Reflux · NA · completed
NCT06475846 — A Trial of HRS5580 in Prevention of Postoperative Nausea and Vomiting of Adults · Phase 2 · completed
NCT06390787 — The Efficacy of B6 and Metoclopramide Combination in Comparison With the Other Antiemetics · Phase 2, PHASE3 · completed

Other recruiting trials for Chemotherapy-induced Nausea and Vomiting

Currently open trials in the same condition.

NCT06120764 — Effect of Guided Imagery on Chemotherapy-related Nausea and Vomiting · NA · recruiting
NCT06017284 — Thalidomide to Chemotherapy Related Nausea and Vomiting in Pancreatic Cancer · Phase 3 · recruiting
NCT05838638 — Serious Gaming for Chemotherapy-induced Nausea and Vomiting · NA · recruiting

Other Federal Research Institute of Pediatric Hematology, Oncology and Immunology trials

Trials by the same sponsor.

NCT07316595 — Study of Treosulfan-Based Conditioning for HSCT in Nijmegen Breakage Syndrome · Phase 2 · not yet recruiting
NCT07375563 — Chemoimmunotherapy Combined With Autologous NK Cell Therapy for Pediatric Patients With Refractory and Relapsed High-Ris · Phase 3 · recruiting
NCT07366801 — Co-infusion of Treg-enriched Donor Lymphocytes With CD3-depleted Hematopoietic Stem Cell Graft to Prevent Graft-versus H · Phase 2, PHASE3 · recruiting
NCT07232134 — The Efficacy of Therapy in Patients With Acute Myeloid Leukemia and Down Syndrome in Russia · Phase 3 · recruiting
NCT06587191 — Emapalumab Efficacy in Children With Primary Hemophagocytic Lymphohistiocytosis · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05346731 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Federal Research Institute of Pediatric Hematology, Oncology and Immunology
Last refreshed: 27 July 2022

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05346731.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing