Trial Information

A Multi-Center, Open-Label, 2-Arm, Randomized, Stratified, Parallel, Pilot Study to Assess Palonosetron vs. Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)

Postoperative nausea and vomiting (PONV) is a frequent complication of surgery, which can
lead to subject discomfort and dissatisfaction as well as considerable subsequent medical
and economic consequences. In this multi-center, open-label, parallel, randomized, pilot
study, outpatient surgical patients who experience post-operative nausea or vomiting in the
PACU will be stratified by gender and randomly assigned to either palonosetron HCl 0.075 mg
IV or ondansetron 4 mg IV in a minimization random allocation. Male or female outpatients,
scheduled for elective laparoscopic abdominal or gynecological surgery under general
endotracheal anesthesia will be enrolled. All subjects will be asked to attend 2 visits to
the study center:

1. Screening (Days -14 to -1)

2. Treatment (Day 1, the day of the surgical procedure and randomization) Subjects treated
will receive a follow-up telephone call by the Study Coordinator on Study Day 4 or 5 to
review the subject diary for completion, to review adverse events, and concomitant
medications, prior to the subject returning the completed diary to the site.

At the Screening visit, subjects who provide their informed consent will undergo a clinical
assessment. Demographic and baseline characteristics, including entrance criteria
determination, medical history, history of PONV and/or currently prone to motion sickness,
smoking status, prior and concomitant medication, physical examination, and vital signs will
be documented.

On the day of surgery, all subjects who meet the eligibility criteria will be
prophylactically treated prior to anesthesia with ondansetron 4 mg IV, as preoperative
antiemetic treatment. As clinically indicated for rescue therapy, subjects experiencing a
nausea severity score ≥4 on the 11-point NRS, vomiting, or indicating a subject request will
receive blinded study medication as their first line rescue therapy for PONV while in the
PACU and no more than 6 hours after PACU admission. Subjects requiring rescue medication
need to be dosed within 10 minutes of identifying the need for rescue medication. In an
effort to ensure that this timeline is not exceeded, the sites will be allowed to randomize
the subject prior to surgery, on the day of surgery. Subjects who are randomized but do not
require rescue therapy and therefore not dosed with study drug, will be considered 'Subjects
randomized but not treated'.

Subject diaries will be used to record the date and time of study drug administration, the
reason for administering rescue medication, baseline emetic symptoms immediately prior to
administration of rescue medication, the occurrence of emetic episodes, the severity and
duration of nausea, and subject functioning evaluations for nausea and emesis assessed
according to the modified Osoba questionnaire (Martin et. al. 2003). The baseline assessment
that is performed just prior to administering the rescue medication must indicate that at
least one of the following conditions was met:

1. the subject had a nausea severity score ≥4 on the 11-point (0-10) NRS

2. vomiting

3. subject request: subject request must be approved by site staff and must be based on
either nausea or emesis symptoms