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

General Anesthesia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568268
• Other study ID #: 2011-11-112
• Secondary ID: CJ_ALX_302
• Status: Completed
• Phase: Phase 3
• First received: March 29, 2012
• Last updated: December 24, 2013
• Start date: January 2012
• Est. completion date: June 2012

Study information

• Verified date: December 2013
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 384
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• General Anesthesia
• Laparoscopic Gynecologic, Abdominal, Other Surgery
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Bungdang Seoul National University Hospital	Seoul
Korea, Republic of	Kangpook Samsung Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Sangye Bahk Hospital, Inje School of Medicine	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	CJ HealthCare Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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