the Efficacy and Safety of Ondansetron Oral Soluble Pellicles

NCT06282211 | Recruiting Phase 3

• 1 other identifier: CHASE 005
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nausea and Vomiting

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Incidence and severity of delayed nauseating in patients from day 5 after chemotherapy until the second cycle of chemotherapy in both groups

  21 days

• Incidence and severity of nausea/vomiting in patients on days 1-4 after chemotherapy in both groups

  4 days

Other Outcomes (1)

• Incidence of adverse events and serious adverse reactions throughout the study period

  21 days

Study Arms (2)

Ondansetron Oral Soluble Pellicles

EXPERIMENTAL

nausea and vomiting prophylaxis with Ondansetron Oral Soluble Pellicles, 8 mg tid for 5-7 days after chemotherapy

Drug: Ondansetron Oral Soluble Pellicles

no antiemetic drugs or drugs with antiemetic active ingredients

SHAM COMPARATOR

no antiemetic drugs or drugs with antiemetic active ingredients for 5-7 days after chemotherapy

Drug: Ondansetron Oral Soluble Pellicles

Interventions

Ondansetron Oral Soluble Pellicles DRUG

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.

Also known as: Aiqisu

Ondansetron Oral Soluble Pellicles; no antiemetic drugs or drugs with antiemetic active ingredients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years, gender is not limited;
• Histologically or cytologically confirmed diagnosis of malignant solid tumor;
• 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
• Nausea and vomiting prophylaxis with a triple regimen of fosaprepitant + ondansetron orally dissolved membrane + dexamethasone started before chemotherapy;
• Expected survival ≥ 3 months;
• Eastern Cooperative Oncology Group (ECOG) physical status score ≤2;
• Patients were able to read, understand, and complete study questionnaires;
• Patients understood the study procedures and signed a written informed consent form

You may not qualify if:

• Patients scheduled to receive multiple days of highly emetogenic chemotherapy within one week;
• 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;
• Symptoms such as vomiting prior to randomization;
• Patients on opioid therapy (except stable dose administration);
• Patients treated with a chemotherapy regimen containing generic paclitaxel (using castor oil as a solvent);
• 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;
• Patients with active infection (e.g., pneumonia) or any uncontrolled disease (e.g., diabetic ketoacidosis, gastrointestinal obstruction) other than malignancy;
• The patient has participated in another clinical trial within the past 4 weeks;
• 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;
• Pregnant or lactating females;
• Presence of allergic conditions or prior serious adverse reactions to the study drug and excipients;
• Suffering from psychological, familial, social, or geographic conditions that may prevent compliance with the study protocol and follow-up schedule;

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Study Sites (1)

Keya Zhi

Weihui, None Selected, 453100, China

RECRUITING

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Yinghua Ji

CONTACT

13663030446; 54234317@qq.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: February 28, 2024
• Study Start: February 20, 2024
• Primary Completion: March 1, 2024
• Study Completion: December 29, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)