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

NCT01568268 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2013-12-25

No results posted yet for this study

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.

Conditions

  • Laparoscopic Gynecologic, Abdominal, Other Surgery
  • General Anesthesia

Interventions

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.

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.

Sponsors & Collaborators

  • HK inno.N Corporation

    collaborator INDUSTRY

  • Samsung Medical Center

    lead OTHER

Principal Investigators

  • Tae Soo Hahm, MD, PhD · Samsung Seoul Hospital, Samsung Medical Center

  • Youn Hong Kim, MD, PhD · Kangpook Samsung Hospital, Samsung Medical Center

  • Jung Won Hwang, MD, PhD · Seoul National University Bundang Hospital

  • Joun Heum Yeon, MD, PhD · Sange Bahk Hospital, Inje School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01568268 on ClinicalTrials.gov