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Trial Title:
Clinical on the Safety and Efficacy of Fosaprepitant Dimeglumine for Injection in the Prevention of CINV.
NCT ID:
NCT05755659
Condition:
Neoplasms
Conditions: Official terms:
Fosaprepitant
Aprepitant
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Fosaprepitant Dimeglumine for Injection
Description:
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.
Arm group label:
Tumor chemotherapy patients
Other name:
ShanQi®️
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).
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Air Force Military Medical University
Address:
City:
Xi'an
Zip:
710032
Country:
China
Status:
Recruiting
Contact:
Last name:
Hong Liu
Phone:
0086-13709284513
Email:
hongliu1@fmmu.edu.cn
Contact backup:
Last name:
Wei Zhou
Phone:
0086-13709284513
Email:
252376698@qq.com
Start date:
July 15, 2022
Completion date:
December 20, 2024
Lead sponsor:
Agency:
Xijing Hospital
Agency class:
Other
Source:
Xijing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05755659
