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

Air Force Military Medical University of People's Liberation Army

Status: Enrolling

Conditions: Neoplasms

Treatments: Drug: Fosaprepitant Dimeglumine for Injection

Study type: Interventional

Funder types: Other

Identifiers

NCT05755659

TQXB-SQ001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 3,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,000 participants in 1 patient group

Tumor chemotherapy patients

Experimental group

Description:

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

Treatment:

Drug: Fosaprepitant Dimeglumine for Injection