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Evaluation of the Efficacy and Safety of Megestrol Acetate in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
Summary
To evaluate the efficacy of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy in Malignant Solid Tumor Patients
Official title: A Phase Ib, Multicenter, Randomized, Double-blind, Placebo-controlled Parallel Group Clinical Study Evaluating the Efficacy and Safety of Megestrol Acetate Oral Suspension in Preventing Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
132
Start Date
2025-09-29
Completion Date
2026-07-31
Last Updated
2025-08-19
Healthy Volunteers
No
Interventions
Low dose of Megestrol Acetate Oral Suspension combined with standard therapy
A single dose of 312.5 mg/day, administered once daily (QD) for 7 consecutive days.
Medium dose of Megestrol Acetate Oral Suspension combined with standard therapy
A single dose of 625 mg/day, administered once daily (QD) for 7 consecutive days.
High dose of Megestrol Acetate Oral Suspension combined with standard therapy
A single dose of 937.5 mg/day, administered once daily (QD) for 7 consecutive days.
Megestrol Acetate Oral Suspension Placebo combined with standard therapy
A single dose of 5 mL/day, administered once daily (QD) for 7 consecutive days.
Locations (1)
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, China