NCT05755659

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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).

Conditions

• Neoplasms

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-07-15
• Primary completion: 2024-10-20
• Completion: 2024-12-20
• First posted: 2023-03-06
• Last updated: 2023-03-06

Locations

1 site across 1 country: China