A Randomized, Double-blind, Multicenter, Parallel Group, Balanced, Stratified Phase 3 Study to Evaluate the Efficacy and the Safety of Single IV Doses of Palonosetron 0.025 mg, 0.050 mg, and 0.075 mg versus Placebo to Prevent Postoperative Nausea and Vomiting Following Elective Gynecologic or Breast Surgery
- Registry ID
- EUCTR2005-000298-23
- Source registry
- EUCTR
- Status
- Completed
- Phase
- PHASE3
- Sponsor
- Helsinn Healthcare SA
- Start date
- 2005-07-19
- Last update
- 2026-08-16
Conditions
- Postoperative nausea and vomiting.
Summary
The objectives of this study are to investigate the efficacy and safety of a single intravenous (IV) dose of palonosetron (0.025 mg, 0.050 mg or 0.075 mg) versus placebo for the prevention of PONV from 0 to 24 hours and 24 to 72 hours in the postoperative period in female inpatients undergoing elective gynecological or breast surgery with general anesthesia.
Locations
View on source registry