NCT05755659

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2022

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 6, 2023

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 20, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2024

Completed
Last Updated

March 6, 2023

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

January 10, 2023

Last Update Submit

February 22, 2023

Conditions

Neoplasms

Outcome Measures

Primary Outcomes (2)

  • Safety of Fosaprepitant Dimeglumine

    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.

    7 day

  • Effectiveness of Fosaprepitant Dimeglumine

    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.

    7 day

Study Arms (1)

Tumor chemotherapy patients

EXPERIMENTAL

To evaluate the safety of Fosaprepitant Dimeglumine for injection in the prevention of nausea and vomiting caused by tumor chemotherapy drugs

Drug: Fosaprepitant Dimeglumine for Injection

Interventions

Fosaprepitant Dimeglumine for InjectionDRUG

The specification of Fosaprepitant Dimeglumine for injection is 150 mg, and the usage and dosage is: when preventing nausea and vomiting caused by HEC, this product is used in combination with dexamethasone and 5-HT3 antagonist. The dosage of Fosaprepitant Dimeglumine for injection is 150 mg, and the infusion time is 20-30 minutes. The intravenous infusion is completed 30 minutes before the beginning of chemotherapy on the first day.

Also known as: ShanQi®️
Tumor chemotherapy patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First Affiliated Hospital of Air Force Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Interventions

fosaprepitantInjections

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Hong Liu

    Digestive surgery

    STUDY CHAIR

Central Study Contacts

Hong Liu

CONTACT

0086-13709284513hongliu1@fmmu.edu.cn

Wei Zhou

CONTACT

0086-13720542643252376698@qq.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2023

First Posted

March 6, 2023

Study Start

July 15, 2022

Primary Completion

October 20, 2024

Study Completion

December 20, 2024

Last Updated

March 6, 2023

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)