the Efficacy and Safety of Ondansetron Oral Soluble Pellicles

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

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.

Study Overview

• Status: Recruiting
• Conditions: Nausea and Vomiting
• Intervention / Treatment: Drug: Ondansetron Oral Soluble Pellicles

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 184
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yinghua Ji; Phone Number: 13663030446; Email: 54234317@qq.com

Study Locations

• China
  • None Selected
    • Weihui, None Selected, China, 453100
      • Recruiting
      • Keya Zhi
      • Contact: Yana Zhang; Phone Number: 15093230340; Email: Drzhangyana@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 + ondansetron orally 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 Criteria:

1. Patients scheduled to receive multiple days of highly emetogenic chemotherapy within one week;
2. Patients using an antiemetic drug other than the study drug or a drug with an antiemetic active ingredient within 48 h prior to initiation of randomization and/or within 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 (using castor 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 before randomization 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 jeopardize the 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 drug and excipients;
12. Suffering from psychological, familial, social, or geographic conditions that may prevent compliance with the study protocol and follow-up schedule;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ondansetron Oral Soluble Pellicles; nausea and vomiting prophylaxis with Ondansetron Oral Soluble Pellicles, 8 mg tid for 5-7 days after chemotherapy	Drug: Ondansetron Oral Soluble Pellicles; patients applying cisplatin-based chemotherapy regimen were treated with the triple combination of fosaprepitant (Tanneng, Jiangsu Haosen Pharmaceutical Group Co., Ltd.) + Ondansetron Oral Soluble Pellicles (Aiqisu, Jiangsu Hengrui Pharmaceutical Co., Ltd.) + dexamethasone for the prophylaxis of nausea and vomiting prior to the chemotherapy, and were divided into the experimental group and the control group by whether or not to continue the prophylaxis with o Ondansetron Oral Soluble Pellicles for 5-7 days after the chemotherapy as shown in the figure below.; Other Names: Aiqisu
Sham Comparator: no antiemetic drugs or drugs with antiemetic active ingredients; no antiemetic drugs or drugs with antiemetic active ingredients for 5-7 days after chemotherapy	Drug: Ondansetron Oral Soluble Pellicles; patients applying cisplatin-based chemotherapy regimen were treated with the triple combination of fosaprepitant (Tanneng, Jiangsu Haosen Pharmaceutical Group Co., Ltd.) + Ondansetron Oral Soluble Pellicles (Aiqisu, Jiangsu Hengrui Pharmaceutical Co., Ltd.) + dexamethasone for the prophylaxis of nausea and vomiting prior to the chemotherapy, and were divided into the experimental group and the control group by whether or not to continue the prophylaxis with o Ondansetron Oral Soluble Pellicles for 5-7 days after the chemotherapy as shown in the figure below.; Other Names: Aiqisu

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of delayed vomiting in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups	The incidence of delayed vomiting was recorded and the severity of delayed vomiting was assessed by the VAS scale.	21 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence and severity of delayed nauseating in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups	The incidence of delayed nauseating was recorded and the severity of delayed nauseating was assessed by the VAS scale.	21 days
Incidence and severity of nausea/vomiting in patients on days 1-4 after chemotherapy in both groups	The incidence of delayed nausea/vomiting was recorded and the severity of delayed nausea/vomiting was assessed by the VAS scale.	4 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events and serious adverse reactions throughout the study period	Record the incidence of adverse events and serious adverse reactions throughout the study period, focusing on events such as constipation and headache, which are common with antiemetics	21 days

Collaborators and Investigators

• Sponsor: The First Affiliated Hospital of Xinxiang Medical College

Study record dates

Study Major Dates

• Study Start (Estimated): February 20, 2024
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): December 29, 2024

Study Registration Dates

• First Submitted: December 19, 2023
• First Submitted That Met QC Criteria: February 20, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 20, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Nausea; Vomiting; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Antiemetics; Gastrointestinal Agents; Dermatologic Agents; Serotonin Agents; Serotonin Antagonists; Serotonin 5-HT3 Receptor Antagonists; Antipruritics; Ondansetron
• Other Study ID Numbers: CHASE 005

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