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

Neoplasms Clinical Trial

— COSEFDIP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05755659
• Other study ID #: TQXB-SQ001
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2022
• Est. completion date: December 20, 2024

Study information

• Verified date: March 2022
• Source: Xijing Hospital
• Contact: Hong Liu
• Phone: 0086-13709284513
• Email: hongliu1[@]fmmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 20, 2024
• Est. primary completion date: October 20, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Air Force Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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