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 - PALO-04-07

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-000298-23-CZ

Enrollment

730

Registered

2005-05-31

Start date

2005-07-19

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative nausea and vomiting. Level: PT Classification code 10054133

Interventions

Trade Name: Aloxi Product Name: Palonosetron Pharmaceutical Form: Solution for injection INN or Proposed INN: Palonosetron HCL CAS Number: 135729-62-3 Current Sponsor code: 08-Palo Concentration unit:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Female, 18 years of age or older, American Society of Anesthesiologists (ASA) physical status 1 to 3, inpatients undergoing elective gynecological or breast surgery under general anesthesia that is expected to last a minimum of 1hour and requires hospitalization of at least 72hours. Patients must provide written informed consent and have at least one of the two following PONV risk factors: 1) history of PONV and/or currently prone to motion sickness; 2) non-smoking status. Scheduled to receive nitrous oxide as part of the maintenance phase of the anesthesia. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Any drug with potential antiemetic efficacy within 24hours prior to anesthetic procedure. Enrollment in a previous study with palonosetron. Any vomiting, retching, or nausea in the 24hours preceding anesthesia. Body mass index>40. Known hypersensitivity/contraindication to 5-hydroxytryptamine subreceptor 3 (5-HT3) antagonists, or study drug excipients.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: none;Primary end point(s): The two co-primary efficacy endpoints are (1) to compare palonosetron (0.025mg, 0.050mg or 0.075mg) with placebo on Complete Response (CR) (defined as no emetic episode and no rescue medication) at 0-24hours, i.e. during the 24-hour postoperative observation period (starting when the patient wakes up and is able to respond to verbal commands postoperatively, e.g., lift head, open eyes, squeeze hand) and (2) to compare palonosetron (0.025mg, 0.050mg or 0.075mg) with placebo on CR at 24 to 72hours, i.e. during the 24-72 hour postoperative observation period.	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: none;Primary end point(s): The two co-primary efficacy endpoints are (1) to compare palonosetron (0.025mg, 0.050mg or 0.075mg) with placebo on Complete Response (CR) (defined as no emetic episode and no rescue medication) at 0-24hours, i.e. during the 24-hour postoperative observation period (starting when the patient wakes up and is able to respond to verbal commands postoperatively, e.g., lift head, open eyes, squeeze hand) and (2) to compare palonosetron (0.025mg, 0.050mg or 0.075mg) with placebo on CR at 24 to 72hours, i.e. during the 24-72 hour postoperative observation period.

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Countries

Czech Republic, Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026