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

February 22, 2023 updated by: Xijing Hospital

Clinical on the Safety and Effectiveness of Fosaprepitant Dimeglumine for Injection in the Prevention of Nausea and Vomiting Caused by Tumor Chemotherapy Drugs.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

3000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • The First Affiliated Hospital of Air Force Military Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tumor chemotherapy patients
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
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.
Other Names:
  • ShanQi®️

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of Fosaprepitant Dimeglumine
Time Frame: 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.
7 day
Effectiveness of Fosaprepitant Dimeglumine
Time Frame: 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.
7 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Study Chair: Hong Liu, Digestive surgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 15, 2022

Primary Completion (Anticipated)

October 20, 2024

Study Completion (Anticipated)

December 20, 2024

Study Registration Dates

First Submitted

January 10, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Estimate)

March 6, 2023

Study Record Updates

Last Update Posted (Estimate)

March 6, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQXB-SQ001

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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