← Back to Search
HR20013 for Nausea and Vomiting Associated With Moderate Emetic Risk Anticancer Agents
Guangzhou, China
Phase 3
Recruiting
Research Sponsored by Fujian Shengdi Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Awards & highlights
Pivotal Trial
Summary
This study is aimed to evaluate the efficacy and safety of HR20013 versus palonosetron for nausea and vomiting associated with moderate emetic risk anticancer agents
See full description
Eligible Conditions
- Chemotherapy-induced nausea and vomiting
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the acute phase (0-24 hours), the delayed phase(24 - 120 hours), and the overall phase (0-120 hours) after initiation of moderate emetic risk anticancer agents, respectively
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Complete response rate in the delayed phase
Secondary study objectives
Adverse events
Complete response rate in the acute phase.
Complete response rate in the overall phase.
+8 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: HR20013 + dexamethasone + palonosetron placeboExperimental Treatment1 Intervention
Group II: Palonosetron + dexamethasone + HR20013 placeboActive Control1 Intervention
Find a Location
Who is running the clinical trial?
Fujian Shengdi Pharmaceutical Co., Ltd.Lead Sponsor
35 Previous Clinical Trials
5,361 Total Patients Enrolled