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the Efficacy and Safety of Ondansetron Oral Soluble Pellicles

NCT06282211 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2024-02-28

No results posted yet for this 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.

Conditions

  • Nausea and Vomiting

Interventions

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Xinxiang Medical College

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-20
Primary Completion
2024-03-01
Completion
2024-12-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06282211 on ClinicalTrials.gov