- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01568268
Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting
December 24, 2013 updated by: Samsung Medical Center
A Randomized, Double Blind, Multicenter Phase III Trial to Evaluate the Therapeutic Efficacy and Safety of Palonosetron in Treatment of Postoperative Nausea and Vomiting
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.
Study Overview
Status
Completed
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
384
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of, 135-710
- Samsung Medical Center
-
Seoul, Korea, Republic of
- Bungdang Seoul National University Hospital
-
Seoul, Korea, Republic of
- Kangpook Samsung Hospital
-
Seoul, Korea, Republic of
- Sangye Bahk Hospital, Inje School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
|
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 Names:
|
Experimental: Palonsetron
|
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 Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response at 24 hr
Time Frame: at 24 hour after randomization
|
Complete response means no retching or vomiting and no administration of secondary rescue drug.
|
at 24 hour after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete response at 72 hr
Time Frame: at 72 hour after randomization
|
Complete response means no retching or vomiting and no administration of secondary rescue drug.
|
at 72 hour after randomization
|
Complete control at 72 hr
Time Frame: at 72 hour after randomization
|
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
|
Complete control at 24 hr
Time Frame: at 24 hour after randomization
|
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
|
the incidence of nausea, retching, vomiting
Time Frame: at 24, 48, 72 hr after randomization
|
the incidence of nausea with numerical rating scale >= 4, retching, vomiting
|
at 24, 48, 72 hr after randomization
|
Time to recovery of nausea, retching, or vomiting
Time Frame: at 24, 48, 72 hr after randomization
|
Time to recovery of nausea, retching, or vomiting from administration of palonosetron
|
at 24, 48, 72 hr after randomization
|
the severity of nausea
Time Frame: at the time of, 24, 48, 72 hour after randomization
|
the severity of nausea measured by NRS (numerical rating scale)
|
at the time of, 24, 48, 72 hour after randomization
|
the incidence of rescue drug use
Time Frame: at 24, 48, 72 hour after randomization
|
the incidence of rescue drug use
|
at 24, 48, 72 hour after randomization
|
QOL by modified Osoba Nausea and Emesis Module
Time Frame: at 24, 48, 72 hour after randomization
|
QOL by modified Osoba Nausea and Emesis Module
|
at 24, 48, 72 hour after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
June 1, 2012
Study Completion (Actual)
June 1, 2012
Study Registration Dates
First Submitted
March 29, 2012
First Submitted That Met QC Criteria
March 30, 2012
First Posted (Estimate)
April 2, 2012
Study Record Updates
Last Update Posted (Estimate)
December 25, 2013
Last Update Submitted That Met QC Criteria
December 24, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Serotonin Agents
- Serotonin Antagonists
- Serotonin 5-HT3 Receptor Antagonists
- Palonosetron
Other Study ID Numbers
- 2011-11-112
- CJ_ALX_302 (Other Identifier: CJ Cheiljedang Corporation)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on General Anesthesia
-
Universidad de AntioquiaCompletedAnesthesia, General | Anesthesia, IntravenousColombia
-
Children's Hospital of PhiladelphiaErasmus Medical Center; University of Texas Southwestern Medical Center; Children... and other collaboratorsCompletedPediatric Anesthesia | General Anesthesia | ElectroencephalographyUnited States, Australia, Switzerland, China, Netherlands
-
University Hospital, SaarlandCompletedGeneral Anesthesia | Regional Anesthesia | Immune FunctionGermany
-
Antalya Training and Research HospitalCompletedAnesthesia, General | Anesthesia, Spinal | Umbilical CordTurkey
-
Nordic Pharma SASCompletedSpinal Anesthesia | Outpatient Surgery | Short General AnesthesiaFrance
-
Samsung Medical CenterUnknownGeneral Anesthesia | Total Intravenous Anesthesia | Bispectral Index MonitoringKorea, Republic of
-
Armed Forces Hospital, PakistanCompletedGeneral Anesthesia | Epidural AnesthesiaPakistan
-
University of Wisconsin, MadisonCompletedGeneral Anesthesia | Intravenous AnesthesiaUnited States
-
Samsun UniversityCompletedAnesthesia | Regional Anesthesia | Anesthesia ManagementTurkey
-
Clinica Alemana de SantiagoNot yet recruitingAnesthesia Morbidity | Perioperative/Postoperative Complications | Anesthesia; Reaction | Anesthesia Complication | Perioperative Complication | Anesthesia; Adverse EffectChile
Clinical Trials on Palonosetron
-
Seoul National University Bundang HospitalRecruiting
-
Incheon St.Mary's HospitalUnknownPostoperative Nausea and VomitingKorea, Republic of
-
Xiamen LP Pharmaceutical Co., LtdRecruitingChemotherapy-induced Nausea and VomitingUnited States
-
Xiamen LP Pharmaceutical Co., LtdCompletedNausea With Vomiting Chemotherapy-InducedUnited States
-
Consorzio OncotechCompletedNEPA to Prevent Chemotherapy Induced Nausea and Vomiting in Patients With Breast Cancer (GIM15-NEPA)Chemotherapy-induced Nausea and Vomiting
-
Helsinn Healthcare SACompletedPostoperative Nausea and VomitingRussian Federation, Ukraine
-
University Hospital, BordeauxBordeaux Association for Training and Research in Obstetric Gynecology; Association...CompletedHyperfibrinolysis | Postpartum HemorrhageFrance
-
Shanghai Changzheng HospitalJiangSu Chia-Tai Tianqin Pharmacy Co.LtdCompletedNeoplasms | Chemotherapy-Induced Nausea and VomitingChina
-
Instituto Nacional de Cancer, BrazilCompletedPostoperative Nausea and VomitingBrazil
-
Duke UniversityEisai Inc.CompletedMalignant GliomaUnited States