Pilot Study to Assess Palonosetron Versus Ondansetron as Rescue Medication in Subjects That Develop Postoperative Nausea and Vomiting (PONV) in the Postanesthesia Care Unit (PACU)
Information source: Eisai Inc.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Postoperative Nausea and Vomiting
Intervention: ondansetron (Drug); palonosetron (Drug)
Phase: Phase 2
Sponsored by: Eisai Inc.
Official(s) and/or principal investigator(s):
David Cox, Study Director, Affiliation: Eisai Inc.
Eisai Medical Services, Phone: 1-888-422-4743
The purpose of this study is to investigate palonosetron versus ondansetron as rescue
medication in subjects that develop postoperative nausea and vomiting (PONV) in the
postanesthesia care unit (PACU).
Official title: 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)
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Proportion of subjects with Complete Control (CC)
Proportion of subjects with a Complete Response (CR)
Proportion of subjects with no emesis
Proportion of subjects with no rescue medication
Change from baseline nausea score using an 11-point Numeric Rating Scale (NRS). Impact of nausea and emesis on Functional Interference.
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
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
3. subject request: subject request must be approved by site staff and must be based on
either nausea or emesis symptoms
Minimum age: 18 Years.
Maximum age: N/A.
1. Male or female ≥18 years of age.
2. American Society of Anesthesiologists (ASA) physical status 1 to 3.
3. Presence of at least 2 of the following PONV risk factors:
- female gender
- history of PONV and/or currently prone to motion sickness (if the subjects
cannot remember their last experience of motion sickness or if they suffered
from it as a child, then they will not be classified as "prone")
- non-smoking status (never smoked or quit ≥12 months ago)
4. Outpatient undergoing elective laparoscopic gynecological or abdominal surgery.
5. Surgery for which anesthesia is expected to last at least 30 minutes.
6. General endotracheal anesthesia conducted as outlined in the anesthetic procedures
section of the protocol.
7. If a subject has a known hepatic, renal or cardiovascular impairment, he/she may be
enrolled in this study at the discretion of the Investigator.
8. If a subject has or may develop prolongation of cardiac conduction intervals,
particularly QTc, he/she may be enrolled at the discretion of the Investigator.
9. If a subject is female of childbearing potential, she must be using reliable
contraceptive measures and have a negative serum beta human chorionic gonadotropin
(β-hCG) pregnancy test within 72 hours prior to surgery on Day 1. Reliable
contraceptive measures include implants, injectables, combined oral contraceptives,
some intrauterine devices, vasectomized partner or sexual abstinence.
Non-childbearing potential is defined as post-menopausal for at least 2 years or
documented surgical sterilization or hysterectomy at least 3 months before study
1. Inability to understand or cooperate with the study procedures as determined by the
2. Women who are pregnant, nursing or planning to become pregnant, are not using
effective birth control, or that have had a positive serum pregnancy test within 72
hours prior to surgery on Day 1.
3. A cancer patient who has had chemotherapy within 4 weeks prior to study entry
4. Any kind of emetogenic radiotherapy within 8 weeks prior to study entry (Screening
5. Has received any investigational drugs within 30 days before study entry.
6. Having taken any drug with potential antiemetic efficacy within 24 hours prior to
7. Any vomiting, retching, or nausea in the 24 hours preceding the administration of
8. Body mass index (BMI) > 40.
9. Known or suspected current history of alcohol abuse or drug abuse.
10. Known hypersensitivity/contraindication to 5-HT3 antagonists or study drug
11. Epileptic patients.
12. Any condition, which in the opinion of the Investigator would make the subject
ineligible for participation in the study.
Locations and Contacts
Eisai Medical Services, Phone: 1-888-422-4743
Precision Trials, Phoenix, Arizona 85032, United States; Recruiting
Accurate Clinical Trials, Inc, Laguna Hills, California 92653, United States; Recruiting
University of California San Francisco, San Francisco, California 94115, United States; Not yet recruiting
Stanford University, Stanford, California 94305, United States; Not yet recruiting
University of Miami- Jackson Memorial Hospital, Miami, Florida 33136, United States; Not yet recruiting
Advanced Surgical Associates, Miami, Florida 33133, United States; Not yet recruiting
University of Kansas Medical Center, Kansas City, Kansas 66160, United States; Not yet recruiting
Duke University Medical Center, Durham, North Carolina 27710, United States; Not yet recruiting
Ohio State University Medical Center, Columbus, Ohio 43210, United States; Not yet recruiting
Scott and White Hospital, Temple, Texas 76508, United States; Recruiting
Starting date: July 2009
Last updated: August 27, 2009