Clinical on the Safety and Efficacy of Fosaprepitant Dimeglumine for Injection in the Prevention of CINV.

Not Applicable

Recruiting

• Conditions: Neoplasms
• Interventions: Drug: Fosaprepitant Dimeglumine for Injection

• Registration Number: NCT05755659
• Lead Sponsor: Xijing Hospital

Brief Summary

To evaluate the safety of Fosaprepitant Dimeglumine Injection for the prevention of nausea and vomiting caused by tumor chemotherapy drugs, analyze the characteristics of the applicable population and clinical medication of Fosaprepitant Dimeglumine, evaluate the risk factors that may affect the efficacy of drug use, and compare the clinical benefits of different drug use modes.

Detailed Description

This is a prospective, one arm, open, non-interference, multi center, observational, real world clinical study.

Study drug: Fosaprepitant Dimeglumine for injection. White or almost white lump or powder, containing 150mg (calculated as C23H22F7N4O6P). This product is a NK-1 receptor antagonist, which is administered jointly with other antiemetic drugs. It is suitable for adult patients to prevent acute and delayed nausea and vomiting during the initial and repeated treatment of highly emetic chemotherapy drugs (HEC).

Study Timeline

• Status Verified: 2022-03
• Study Start: 2022-07-15
• Study First Submitted: 2023-01-10
• Study First Submitted QC: 2023-02-22
• Last Update Submitted: 2023-02-22
• Study First Posted: 2023-03-06
• Last Update Posted: 2023-03-06
• Primary Completion: 2024-10-20
• Study Completion: 2024-12-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3000

Inclusion Criteria

• Patients with nausea and vomiting caused by chemotherapy
• Patients who volunteered to participate in the study

Exclusion Criteria

• Hypersensitive to any component in this product
• Patients taking pimozide, terfenadine, astemizole and cisapride

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tumor chemotherapy patients	Fosaprepitant Dimeglumine for Injection	To evaluate the safety of Fosaprepitant Dimeglumine for injection in the prevention of nausea and vomiting caused by tumor chemotherapy drugs

Primary Outcome Measures

Name	Time	Method
Safety of Fosaprepitant Dimeglumine	7 day	Safety evaluation: observe the known adverse reactions (including those found in preclinical studies, clinical studies, previous routine monitoring, and those in the same product of aspirin) and whether there are new adverse reactions, and observe the incidence and occurrence of these adverse reactions (occurrence characteristics, severity, risk factors), At the same time, we should pay attention to the occurrence of adverse reactions of drugs used in special groups (pregnant women, children, the elderly, patients with liver and kidney dysfunction), and the safety of different chemotherapy schemes.
Effectiveness of Fosaprepitant Dimeglumine	7 day	Efficacy evaluation: complete control rate (CR), that is, the proportion of patients without vomiting and without remedial drugs; Including acute CR (0-24h) and delayed vomiting CR (25-120h). To evaluate the applicable population characteristics and clinical medication characteristics of fosapitam, observe the efficacy of fosapitam in different chemotherapy schemes, tumor types and different dosage schemes, preliminarily analyze the risk factors affecting the efficacy of fosapitam, and compare the clinical benefits of different medication modes.

Trial Locations

Locations (1)

The First Affiliated Hospital of Air Force Military Medical University; 🇨🇳 Xi'an, Shaanxi, China