Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting

December 24, 2013 updated by: Samsung Medical Center

A Randomized, Double Blind, Multicenter Phase III Trial to Evaluate the Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting

This study was designed to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.

Study Overview

Detailed Description

Postoperative nausea and vomiting (PONV) is a frequent complication of surgery, which can produce subject discomfort with medical and economic consequences. This study was designed to evaluate the treatment efficacy and safety of palonosetron for the subjects who undergo gynecologic or simple laparoscopic surgery. As the previous studies of palonosetron evaluated only the prevention of postoperative nausea and vomiting (PONV), there was no evidence-based guideline of palonosetron for treatment of PONV. The aim of the present study is to evaluate the treatment efficacy and safety of palonosetron for the patients who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia.

Study Type

Interventional

Enrollment (Actual)

384

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Seoul, Korea, Republic of, 135-710
        • Samsung Medical Center
      • Seoul, Korea, Republic of
        • Bungdang Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Kangpook Samsung Hospital
      • Seoul, Korea, Republic of
        • Sangye Bahk Hospital, Inje School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 19 years and older, younger than 70 years old
  • American society of Anesthesiologists physical status classification I to III
  • those who undergo laparoscopic gynecologic, abdominal or other surgery under general anesthesia
  • surgery for which anesthesia is expected to last at least 30 minutes
  • if a subject has or may develop prolongation of cardiac conduction intervals, particularly corrected QT interval, he/she may be enrolled at the discretion of the investigator.

Exclusion Criteria:

  • known hypersensitivity/ contraindication to 5-hydroxytryptamine antagonists or study drug excipient
  • 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 7 days prior to surgery day 1.
  • has received any investigational drug within 30 days before study entry
  • having taken any drug with potential antiemetic efficacy within 24 hour prior to anesthetic procedures.
  • any vomiting, retching, or nausea in the 24 hours preceding the administration of anesthesia
  • known or suspected current history of alcohol abuse or drug abuse.
  • any condition, which in the opinion of the investigator would make the subject ineligible for participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
placebo intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.
Other Names:
  • placebo
Experimental: Palonsetron
palonosetron 0.075 mg intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.
Other Names:
  • Aloxi (palonosetron)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response at 24 hr
Time Frame: at 24 hour after randomization
Complete response means no retching or vomiting and no administration of secondary rescue drug.
at 24 hour after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete response at 72 hr
Time Frame: at 72 hour after randomization
Complete response means no retching or vomiting and no administration of secondary rescue drug.
at 72 hour after randomization
Complete control at 72 hr
Time Frame: at 72 hour after randomization
Complete control means no retching or vomiting and no nausea with numerical rating scale >= 4 and no administration of secondary rescue drug.
at 72 hour after randomization
Complete control at 24 hr
Time Frame: at 24 hour after randomization
Complete control means no retching or vomiting and no nausea with numerical rating scale >= 4 and no administration of secondary rescue drug.
at 24 hour after randomization
the incidence of nausea, retching, vomiting
Time Frame: at 24, 48, 72 hr after randomization
the incidence of nausea with numerical rating scale >= 4, retching, vomiting
at 24, 48, 72 hr after randomization
Time to recovery of nausea, retching, or vomiting
Time Frame: at 24, 48, 72 hr after randomization
Time to recovery of nausea, retching, or vomiting from administration of palonosetron
at 24, 48, 72 hr after randomization
the severity of nausea
Time Frame: at the time of, 24, 48, 72 hour after randomization
the severity of nausea measured by NRS (numerical rating scale)
at the time of, 24, 48, 72 hour after randomization
the incidence of rescue drug use
Time Frame: at 24, 48, 72 hour after randomization
the incidence of rescue drug use
at 24, 48, 72 hour after randomization
QOL by modified Osoba Nausea and Emesis Module
Time Frame: at 24, 48, 72 hour after randomization
QOL by modified Osoba Nausea and Emesis Module
at 24, 48, 72 hour after randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Study Director: Tae Soo Hahm, MD, PhD, Samsung Seoul Hospital, Samsung Medical Center
  • Principal Investigator: Youn Hong Kim, MD, PhD, Kangpook Samsung Hospital, Samsung Medical Center
  • Principal Investigator: Jung Won Hwang, MD, PhD, Bundang Seoul National University Hospital
  • Principal Investigator: Joun Heum Yeon, MD, PhD, Sange Bahk Hospital, Inje School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

March 29, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 2, 2012

Study Record Updates

Last Update Posted (Estimate)

December 25, 2013

Last Update Submitted That Met QC Criteria

December 24, 2013

Last Verified

December 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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