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)
Postoperative Nausea and Vomiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Proportion of subjects with Complete Control (CC) [ Time Frame: From 0 to 72 hours postdose ] [ Designated as safety issue: No ]
- Proportion of subjects with a Complete Response (CR) [ Time Frame: From 0 to 72 hours postdose ] [ Designated as safety issue: No ]
- Proportion of subjects with no emesis [ Time Frame: From 0 to 72 hours postdose ] [ Designated as safety issue: No ]
- Proportion of subjects with no rescue medication [ Time Frame: From 0 to 72 hours postdose ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: 1||
Subjects will receive ondansetron 4 mg intravenously (IV) and will be followed for 72 hours.
Ondansetron is a selective 5-HT3 receptor antagonist. It is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin and prevention of postoperative nausea and/or vomiting.
Other Name: Zofran
|Active Comparator: 2||
Subjects will receive palonosetron HCl 0.075 mg IV and will be followed for 72 hours.
Palonosetron hydrochloride (Aloxi®) is a potent and selective 5-HT3 receptor antagonist for the prevention of acute nausea and vomiting associated with initial and repeat courses of moderately and highly emetogenic cancer chemotherapy, the prevention of delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy, and the prevention of postoperative nausea and vomiting for up to 24 hours following surgery.
Other Name: aloxi
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:
- Screening (Days -14 to -1)
- 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:
- the subject had a nausea severity score ≥4 on the 11-point (0-10) NRS
- subject request: subject request must be approved by site staff and must be based on either nausea or emesis symptoms
Please refer to this study by its ClinicalTrials.gov identifier: NCT00967499
|United States, Arizona|
|Phoenix, Arizona, United States, 85032|
|United States, California|
|Accurate Clinical Trials, Inc|
|Laguna Hills, California, United States, 92653|
|University of California San Francisco|
|San Francisco, California, United States, 94115|
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|United States, North Carolina|
|Duke University Medical Center|
|Durham, North Carolina, United States, 27710|
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|United States, Texas|
|Scott and White Hospital|
|Temple, Texas, United States, 76508|
|Study Director:||David Cox||Eisai Inc.|