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)

This study has been completed.
Sponsor:
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00967499
First received: August 27, 2009
Last updated: May 6, 2010
Last verified: May 2010
  Purpose

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 Postanaesthesia Care Unit (PACU).


Condition Intervention Phase
Postoperative Nausea and Vomiting
Drug: ondansetron
Drug: palonosetron
Phase 2

Study Type: Interventional
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)

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • Proportion of subjects with Complete Control (CC) [ Time Frame: From 0 to 72 hours postdose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 300
Study Start Date: July 2009
Study Completion Date: April 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Drug: ondansetron

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 Drug: palonosetron

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

Detailed Description:

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  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 start.

Exclusion Criteria:

  1. Inability to understand or cooperate with the study procedures as determined by the Investigator.
  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 (Screening visit).
  4. Any kind of emetogenic radiotherapy within 8 weeks prior to study entry (Screening visit).
  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 anesthetic procedures.
  7. Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia .
  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 excipients.
  11. Epileptic patients.
  12. Any condition, which in the opinion of the Investigator would make the subject ineligible for participation in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967499

Locations
United States, Arizona
Precision Trials
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
Sponsors and Collaborators
Eisai Inc.
Investigators
Study Director: David Cox Eisai Inc.
  More Information

No publications provided

Responsible Party: Sunita Hack, Eisai inc.
ClinicalTrials.gov Identifier: NCT00967499     History of Changes
Other Study ID Numbers: PALO-08-11
Study First Received: August 27, 2009
Last Updated: May 6, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Eisai Inc.:
PONV
rescue

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Palonosetron
Ondansetron
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on September 30, 2014