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)

NCT00967499 | Completed Phase 2 Results

• 1 other identifier: PALO-08-11
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 8

Brief Summary

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).

Conditions

Postoperative Nausea and Vomiting

Keywords

PONV; rescue

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Complete Control

  Complete control was defined as participants with no emetic episode, no rescue medication, and no more than 3 on the nausea numeric rating scale (NRS) severity score. The 11-point NRS scale (ranging from 0-10), where 0 means no nausea, 2 or 3 was mild nausea, around 5 was moderate nausea, 7 and higher was severe nausea and 10 means the worst possible nausea. Higher scores were considered as worse outcome.

  Up to 72 hours postdose

Secondary Outcomes (5)

• Percentage of Participants With Complete Response

  Up to 72 hours postdose

• Percentage of Participants Who Did Not Experience Any Episode of Emesis

  Up to 72 hours postdose

• Percentage of Participants Who Did Not Receive Any Rescue Medication Post-surgical Procedure

  Up to 72 hours postdose

• Change From Baseline in Nausea Severity Score

  Baseline up to 72 hours postdose

• Modified Osoba Nausea and Emesis Module Questionnaire Score

  24, 48 and 72 hours postdose

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: Ondansetron

2

ACTIVE COMPARATOR

Drug: Palonosetron

Interventions

Ondansetron DRUG

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.

Also known as: Zofran

1

Palonosetron DRUG

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.

Also known as: Aloxi

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female \>=18 years of age.
• American Society of Anesthesiologists (ASA) physical status 1 to 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)
• Outpatient undergoing elective laparoscopic gynecological or abdominal surgery
• Surgery for which anesthesia is expected to last at least 30 minutes
• General endotracheal anesthesia conducted as outlined in the anesthetic procedures section of the protocol
• 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
• 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.
• 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.

You may not qualify if:

• Inability to understand or cooperate with the study procedures as determined by the Investigator.
• 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.
• A cancer patient who has had chemotherapy within 4 weeks prior to study entry (Screening visit).
• Any kind of emetogenic radiotherapy within 8 weeks prior to study entry (Screening visit).
• Has received any investigational drugs within 30 days before study entry.
• Having taken any drug with potential antiemetic efficacy within 24 hours prior to anesthetic procedures.
• Any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia .
• Body mass index (BMI) \> 40.
• Known or suspected current history of alcohol abuse or drug abuse.
• Known hypersensitivity/contraindication to 5-HT3 antagonists or study drug excipients.
• Epileptic patients.
• Any condition, which in the opinion of the Investigator would make the subject ineligible for participation in the study.

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (8)

Precision Trials

Phoenix, Arizona, 85032, United States

Location

Accurate Clinical Trials, Inc

Laguna Hills, California, 92653, United States

Location

University of California San Francisco

San Francisco, California, 94115, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Scott and White Hospital

Temple, Texas, 76508, United States

Location

Related Publications (1)

• Candiotti KA, Ahmed SR, Cox D, Gan TJ. Palonosetron versus ondansetron as rescue medication for postoperative nausea and vomiting: a randomized, multicenter, open-label study. BMC Pharmacol Toxicol. 2014 Aug 16;15:45. doi: 10.1186/2050-6511-15-45.

  PMID: 25127659 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Ondansetron; Palonosetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Isoquinolines

Results Point of Contact

• Title: Eisai Medical Services
• Organization: Eisai, Inc.

esi_medinfo@eisai.com

1-888-422-4743

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: July 13, 2009
• Primary Completion: December 18, 2009
• Study Completion: December 18, 2009
• Last Updated: January 11, 2021
• Results First Posted: January 11, 2021

Record last verified: 2020-12

Locations

US (8)