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

Primary Purpose

Laparoscopic Gynecologic, Abdominal, Other Surgery, General Anesthesia

Status

Completed

Phase

Phase 3

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Palonosetron

placebo control group

About this trial

This is an interventional treatment trial for Laparoscopic Gynecologic, Abdominal, Other Surgery focused on measuring palonosetron, postoperative nausea and vomiting

Eligibility Criteria

19 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Samsung Medical Center
Bungdang Seoul National University Hospital
Kangpook Samsung Hospital
Sangye Bahk Hospital, Inje School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Palonsetron

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Complete response at 24 hr

Complete response means no retching or vomiting and no administration of secondary rescue drug.

Secondary Outcome Measures

Complete response at 72 hr

Complete response means no retching or vomiting and no administration of secondary rescue drug.

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.

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.

the incidence of nausea, retching, vomiting

the incidence of nausea with numerical rating scale >= 4, retching, vomiting

Time to recovery of nausea, retching, or vomiting

Time to recovery of nausea, retching, or vomiting from administration of palonosetron

the severity of nausea

the severity of nausea measured by NRS (numerical rating scale)

the incidence of rescue drug use

QOL by modified Osoba Nausea and Emesis Module

Full Information

NCT ID

NCT01568268

First Posted

March 29, 2012

Last Updated

December 24, 2013

Sponsor

Samsung Medical Center

Collaborators

HK inno.N Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01568268

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Samsung Medical Center

Collaborators

HK inno.N Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laparoscopic Gynecologic, Abdominal, Other Surgery, General Anesthesia

Keywords

palonosetron, postoperative nausea and vomiting

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

384 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Palonsetron

Arm Type

Experimental

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Palonosetron

Other Intervention Name(s)

Aloxi (palonosetron)

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

placebo control group

Other Intervention Name(s)

placebo

Intervention Description

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.

Primary Outcome Measure Information:

Title

Complete response at 24 hr

Description

Complete response means no retching or vomiting and no administration of secondary rescue drug.

Time Frame

at 24 hour after randomization

Secondary Outcome Measure Information:

Title

Complete response at 72 hr

Description

Complete response means no retching or vomiting and no administration of secondary rescue drug.

Time Frame

at 72 hour after randomization

Title

Complete control at 72 hr

Description

Complete control means no retching or vomiting and no nausea with numerical rating scale >= 4 and no administration of secondary rescue drug.

Time Frame

at 72 hour after randomization

Title

Complete control at 24 hr

Description

Complete control means no retching or vomiting and no nausea with numerical rating scale >= 4 and no administration of secondary rescue drug.

Time Frame

at 24 hour after randomization

Title

the incidence of nausea, retching, vomiting

Description

the incidence of nausea with numerical rating scale >= 4, retching, vomiting

Time Frame

at 24, 48, 72 hr after randomization

Title

Time to recovery of nausea, retching, or vomiting

Description

Time to recovery of nausea, retching, or vomiting from administration of palonosetron

Time Frame

at 24, 48, 72 hr after randomization

Title

the severity of nausea

Description

the severity of nausea measured by NRS (numerical rating scale)

Time Frame

at the time of, 24, 48, 72 hour after randomization

Title

the incidence of rescue drug use

Description

the incidence of rescue drug use

Time Frame

at 24, 48, 72 hour after randomization

Title

QOL by modified Osoba Nausea and Emesis Module

Description

QOL by modified Osoba Nausea and Emesis Module

Time Frame

at 24, 48, 72 hour after randomization

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tae Soo Hahm, MD, PhD

Organizational Affiliation

Samsung Seoul Hospital, Samsung Medical Center

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Youn Hong Kim, MD, PhD

Organizational Affiliation

Kangpook Samsung Hospital, Samsung Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Jung Won Hwang, MD, PhD

Organizational Affiliation

Bundang Seoul National University Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joun Heum Yeon, MD, PhD

Organizational Affiliation

Sange Bahk Hospital, Inje School of Medicine

Official's Role

Principal Investigator

Facility Information:

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Bungdang Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Kangpook Samsung Hospital

City

Seoul

Country

Korea, Republic of

Facility Name

Sangye Bahk Hospital, Inje School of Medicine

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Citations:

PubMed Identifier

25037960

Citation

Hahm TS, Hwang JW, Kim WH, Oh EJ, Kim DK, Choi WJ, Kim YH, Ryu JH, Yoo BH, Yon JH. A prospective, randomized, double-blind, multicenter trial to evaluate the therapeutic efficacy and safety of palonosetron in the treatment of postoperative nausea and vomiting over a 72-h period. J Anesth. 2015 Feb;29(1):21-8. doi: 10.1007/s00540-014-1884-9. Epub 2014 Jul 19.

Results Reference

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

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