Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting - Full Text View

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:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Palonosetron Palonosetron hydrochloride

U.S. FDA Resources

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 vomitting 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 vomitting 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 vomitting and no nausea with NRS >= 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 vomitting and no nausea with NRS >= 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 NRS >= 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

Estimated Enrollment:	150
Study Start Date:	January 2012
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	December 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 QTc, he/she may be enrolled at the discretion of the investigator.

Exclusion Criteria:

known hypersensitivity/ contraindication to 5-HT3 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01568268

Contacts

Contact: Tae Soo Hahm, MD, PhD	82-2-3410-0364	ts.hahm@samsung.com
Contact: Won Ho Kim, MD	82-2-3410-2470	bullet57@naver.com

Locations

Korea, Republic of
Kangpook Samsung Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Youn Hong Kim, MD, PhD
Bungdang Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of
Contact: Jung Won Hwang, MD, PhD
Sangye Bahk Hospital, Inje School of Medicine	Recruiting
Seoul, Korea, Republic of
Contact: Joun Heum Yeon, MD, PhD
Samsung Medical Center	Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Tae Soo Hahm, MD, PhD 82-2-3410-0364 ts.hahm@samsung.com
Contact: Won Ho Kim, MD 82-2-3410-2470 bullet57@naver.com
Sub-Investigator: Tae Soo Hahm, MD, PhD

Sponsors and Collaborators

Samsung Medical Center

CJ Cheiljedang 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:	April 9, 2012
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 May 21, 2013