the Efficacy and Safety of Ondansetron Oral Soluble Pellicles

Last updated: February 20, 2024
Sponsor: The First Affiliated Hospital of Xinxiang Medical College
Overall Status: Active - Recruiting

Phase

3

Condition

Colic

Vomiting

Gastroenteritis

Treatment

Ondansetron Oral Soluble Pellicles

Clinical Study ID

NCT06282211
CHASE 005
  • Ages > 18
  • All Genders

Study Summary

The name of this prospective study is a multicenter, open-label, randomized controlled clinical study of the efficacy and safety of Ondansetron Oral Soluble Pellicles for the prevention of delayed nausea and vomiting induced by highly emetogenic chemotherapy.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years, gender is not limited;
  2. Histologically or cytologically confirmed diagnosis of malignant solid tumor;
  3. Initial highly emetogenic one-day chemotherapy regimen (cisplatin dose 60-75 mg/m2;anthracycline compound adriamycin ≥ 60 mg/m2 or epothilone ≥ 90 mg/m2 ); and
  4. Nausea and vomiting prophylaxis with a triple regimen of fosaprepitant + ondansetronorally dissolved membrane + dexamethasone started before chemotherapy;
  5. Expected survival ≥ 3 months;
  6. Eastern Cooperative Oncology Group (ECOG) physical status score ≤2;
  7. Patients were able to read, understand, and complete study questionnaires;
  8. Patients understood the study procedures and signed a written informed consent form

Exclusion

Exclusion Criteria:

  1. Patients scheduled to receive multiple days of highly emetogenic chemotherapy withinone week;
  2. Patients using an antiemetic drug other than the study drug or a drug with anantiemetic active ingredient within 48 h prior to initiation of randomization and/orwithin one week of enrollment;
  3. Symptoms such as vomiting prior to randomization;
  4. Patients on opioid therapy (except stable dose administration);
  5. Patients treated with a chemotherapy regimen containing generic paclitaxel (usingcastor oil as a solvent);
  6. Patients who have received, or are expected to receive, radiotherapy to the abdomen (including the diaphragmatic plane and below) or pelvis within 1 week beforerandomization or one week after enrollment;
  7. Patients with active infection (e.g., pneumonia) or any uncontrolled disease (e.g.,diabetic ketoacidosis, gastrointestinal obstruction) other than malignancy;
  8. The patient has participated in another clinical trial within the past 4 weeks;
  9. Any condition that, in the judgment of the investigator, is unstable or may jeopardizethe safety of the subject and his or her compliance with the study;
  10. Pregnant or lactating females;
  11. Presence of allergic conditions or prior serious adverse reactions to the study drugand excipients;
  12. Suffering from psychological, familial, social, or geographic conditions that mayprevent compliance with the study protocol and follow-up schedule;

Study Design

Total Participants: 184
Treatment Group(s): 1
Primary Treatment: Ondansetron Oral Soluble Pellicles
Phase: 3
Study Start date:
February 20, 2024
Estimated Completion Date:
December 29, 2024

Study Description

The aim of this study is to observe the efficacy and safety of ondansetron in delayed nausea and vomiting by its continuous dosing, and it is planned to enroll 184 first-time recipients of highly emetogenic single-day chemotherapy regimens (cisplatin dose 60-75 mg/m2; anthracycline compounds adriamycin ≥ 60 mg/m2 or epothilone ≥ 90 mg/m2 ) who were initiated on a triple combination regimen of fosaprepitant + ondansetron orally soluble film + dexamethasone triple regimen for nausea and vomiting prophylaxis in patients. The primary observation was the incidence and severity of delayed nausea and vomiting in both groups from day 5 after chemotherapy to the second cycle of chemotherapy. The secondary observation indexes include the incidence and severity of delayed nausea in patients in both groups from day 5 after chemotherapy to before the second cycle of chemotherapy; the incidence and severity of anticipatory nausea/vomiting in the second cycle of chemotherapy in both groups; the incidence and severity of nausea/vomiting in patients in both groups on days 1-4 after chemotherapy; and the incidence of adverse events and serious adverse reactions, with a focus on the antiemetic drugs common constipation, headache and other events. This trial was randomized into groups, and the experimental group was preset as group A and the control group as group B. The prevention of nausea and vomiting was carried out with the triple regimen of fosaprepitant (Tanneng, Jiangsu Hausen Pharmaceutical Group Co., Ltd.) + Ondansetron Oral Soluble Pellicles (Aiqisu, Jiangsu Hengrui Pharmaceutical Co., Ltd.) + dexamethasone prior to chemotherapy, and the patients were divided into the treatment group A and the control group B by the use of Ondansetron Oral Soluble Pellicles for continuation of the prophylaxis on the 5-7 days after the chemotherapy.

Connect with a study center

  • Keya Zhi

    Weihui, None Selected 453100
    China

    Active - Recruiting

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