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

This study has been completed.
Sponsor:
Collaborator:
CJ HealthCare Corporation
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01568268
First received: March 29, 2012
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Laparoscopic Gynecologic, Abdominal, Other Surgery
General Anesthesia
Drug: Palonosetron
Drug: placebo control group
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Multicenter Phase III Trial to Evaluate the Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Complete response at 24 hr [ Time Frame: at 24 hour after randomization ] [ Designated as safety issue: No ]
    Complete response means no retching or vomiting and no administration of secondary rescue drug.


Secondary Outcome Measures:
  • Complete response at 72 hr [ Time Frame: at 72 hour after randomization ] [ Designated as safety issue: No ]
    Complete response means no retching or vomiting and no administration of secondary rescue drug.

  • Complete control at 72 hr [ Time Frame: at 72 hour after randomization ] [ Designated as safety issue: No ]
    Complete control means no retching or vomiting and no nausea with numerical rating scale >= 4 and no administration of secondary rescue drug.

  • Complete control at 24 hr [ Time Frame: at 24 hour after randomization ] [ Designated as safety issue: No ]
    Complete control means no retching or vomiting and no nausea with numerical rating scale >= 4 and no administration of secondary rescue drug.

  • the incidence of nausea, retching, vomiting [ Time Frame: at 24, 48, 72 hr after randomization ] [ Designated as safety issue: No ]
    the incidence of nausea with numerical rating scale >= 4, retching, vomiting

  • Time to recovery of nausea, retching, or vomiting [ Time Frame: at 24, 48, 72 hr after randomization ] [ Designated as safety issue: No ]
    Time to recovery of nausea, retching, or vomiting from administration of palonosetron

  • the severity of nausea [ Time Frame: at the time of, 24, 48, 72 hour after randomization ] [ Designated as safety issue: No ]
    the severity of nausea measured by NRS (numerical rating scale)

  • the incidence of rescue drug use [ Time Frame: at 24, 48, 72 hour after randomization ] [ Designated as safety issue: No ]
    the incidence of rescue drug use

  • QOL by modified Osoba Nausea and Emesis Module [ Time Frame: at 24, 48, 72 hour after randomization ] [ Designated as safety issue: No ]
    QOL by modified Osoba Nausea and Emesis Module


Enrollment: 384
Study Start Date: January 2012
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Palonsetron Drug: Palonosetron
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 Name: Aloxi (palonosetron)
Placebo Comparator: Placebo Drug: placebo control group
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 Name: placebo

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.

  Eligibility

Ages Eligible for Study:   19 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01568268

Locations
Korea, Republic of
Kangpook Samsung Hospital
Seoul, Korea, Republic of
Bungdang Seoul National University Hospital
Seoul, Korea, Republic of
Sangye Bahk Hospital, Inje School of Medicine
Seoul, Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
CJ HealthCare Corporation
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
  More Information

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01568268     History of Changes
Other Study ID Numbers: 2011-11-112, CJ_ALX_302
Study First Received: March 29, 2012
Last Updated: December 24, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
palonosetron
postoperative nausea and vomiting

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Palonosetron
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014