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

NCT01568268 | Completed Phase 3 DMC

• 2 other identifiers: 2011-11-112CJ_ALX_302
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 4

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.

Conditions

Laparoscopic Gynecologic, Abdominal, Other Surgery; General Anesthesia

Keywords

palonosetron; postoperative nausea and vomiting

Outcome Measures

Primary Outcomes (1)

• Complete response at 24 hr

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

  at 24 hour after randomization

Secondary Outcomes (8)

• Complete response at 72 hr

  at 72 hour after randomization

• Complete control at 72 hr

  at 72 hour after randomization

• Complete control at 24 hr

  at 24 hour after randomization

• the incidence of nausea, retching, vomiting

  at 24, 48, 72 hr after randomization

• Time to recovery of nausea, retching, or vomiting

  at 24, 48, 72 hr after randomization

Study Arms (2)

Palonsetron

EXPERIMENTAL

Drug: Palonosetron

Placebo

PLACEBO COMPARATOR

Drug: placebo control group

Interventions

Palonosetron DRUG

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.

Also known as: Aloxi (palonosetron)

Palonsetron

placebo control group DRUG

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.

Also known as: placebo

Placebo

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• HK inno.N Corporation: collaborator

Study Sites (4)

Samsung Medical Center

Seoul, Seoul, 135-710, South Korea

Location

Bungdang Seoul National University Hospital

Seoul, South Korea

Location

Kangpook Samsung Hospital

Seoul, South Korea

Location

Sangye Bahk Hospital, Inje School of Medicine

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 25037960 DERIVED

MeSH Terms

Conditions

Postoperative Nausea and Vomiting

Interventions

Palonosetron

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Nausea; Signs and Symptoms, Digestive; Signs and Symptoms; Vomiting

Intervention Hierarchy (Ancestors)

Quinuclidines; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Tae Soo Hahm, MD, PhD

  Samsung Seoul Hospital, Samsung Medical Center

  STUDY DIRECTOR

• Youn Hong Kim, MD, PhD

  Kangpook Samsung Hospital, Samsung Medical Center

  PRINCIPAL INVESTIGATOR

• Jung Won Hwang, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

• Joun Heum Yeon, MD, PhD

  Sange Bahk Hospital, Inje School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2012
• First Posted: April 2, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: December 25, 2013

Record last verified: 2013-12

Locations

KR (4)