Comparative Study on the Efficacy and Safety of Ondansetron Oral Membrane for the Prevention of Vomiting During Moderate Hypoemetic Chemotherapy (Ondansetron)

April 15, 2024 updated by: Shanghai Children's Medical Center
Children aged 4-15 years scheduled to receive Moderate or low emetic chemotherapy were randomly assigned to arm-A (Ondansetron mouth soluble film) or arm-B (Ondansetron tablet). Children recruited to arm-A received ondansetron mouth soluble film plus dexamethasone. Children recruited to arm-B received Ondansetron tablet plus dexamethasone. Ondansetron and dexamethasone were given continuously until 48hours after completion of chemotherapy. The primary end point of the study was to determine the proportion of patients who achieved a CR, defined as no vomiting, no retching, and no use of rescue medication, the proportion of patients who achieved a CR during the acute phase (0-24 hours) after administration of the last dose of chemotherapy. Secondary end points were the proportion of patients who achieved a CR during the 24-120 hours (delayed phase) and overall after administration of the last dose of chemotherapy

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 4 to 15 years who have been diagnosed with malignant tumor through pathological examination and need to receive chemotherapy, gender is not limited;
  • Receive moderate and low grade emetic chemotherapy;
  • Patients with a score greater than 60 or higher have a life expectancy greater than 3 months;
  • The patients were enrolled voluntarily, and the family members signed the informed consent, and the family members had good compliance and accurately recorded the vomiting diary.

Exclusion Criteria:

  • Children allergic to 5HT3 antagonists;
  • Active infection;
  • Abnormal bone marrow function (absolute neutrophil count <1000/mm3 platelet count <100000/mm3);
  • Abnormal renal function in serum creatinine beyond the upper age limit of normal (ULN);
  • Abnormal liver function of serum aspartate aminotransferase and alanine aminotransferase, age and serum bilirubin are 1.5 times that of ULN;
  • vomiting 24 hours before chemotherapy begins;
  • Start systemic corticosteroid therapy within 72 hours prior to study drug use, or plan to receive corticosteroids as part of a chemotherapy regimen;
  • Patients with benzodiazepines or opioids

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ondansetron mouth soluble film
Drug: ondansetron plus dexamethasone Ondansetron oral membrane lysis group, oral administration 30 minutes before chemotherapy, 8 mg bid for children over 12 years old, 4mg/ time for children 4-11 years old, bid; Dexamethasone was administered intravenously at 0.225 mg/(kg·d) 30 minutes before chemotherapy until 2 days after the end of the last dose of chemotherapy
Drug: Ondansetron oral membrane
A new oral film formulation of ondansetron was used to replace traditional tablets in the treatment of antiemetic chemotherapy
Experimental: Ondansetron tablet
Ondansetron tablet group, oral administration 30 minutes before chemotherapy, 5mg/m2 q12h po; Dexamethasone was administered intravenously at 0.225 mg/(kg·d) 30 minutes before chemotherapy until 2 days after the end of the last dose of chemotherapy
Drug: Ondansetron oral membrane
A new oral film formulation of ondansetron was used to replace traditional tablets in the treatment of antiemetic chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Remission Rates in the Acute Phases
Time Frame: up to 6 months
Complete Remission Rates in the Acute Phases
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Remission Rates in the Delayed Phases
Time Frame: up to 6 months
Complete Remission Rates in the Delayed Phases
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Children's Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

April 15, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 15, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ondansetron mouth soluble film

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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