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
- Conditions
- Postoperative nausea and vomiting.Level: PTClassification code 10054133
- Registration Number
- EUCTR2005-000298-23-DE
- Lead Sponsor
- Helsinn Healthcare SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 730
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method