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Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients

Information source: Helsinn Healthcare SA
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Nausea and Vomiting

Intervention: Palonosetron (Drug); Ondansetron (Drug); Placebo to Ondansetron (Drug); Placebo to Palonosetron (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Helsinn Healthcare SA


The primary objective of this study is to evaluate the efficacy of a single palonosetron IV dose compared to a single ondansetron IV dose in the prevention of postoperative nausea and vomiting through 24 hours after surgery in children aged from neonates up to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia. The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.

Clinical Details

Official title: A Multicenter, Double-blind, Double-dummy, Randomized, Parallel Group, Stratified Study to Evaluate the Efficacy and Safety of a Single IV Dose of Palonosetron Compared to a Single IV Dose of Ondansetron to Prevent Postoperative Nausea and Vomiting in Pediatric Patients.

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

Primary outcome: Proportion of Patients With Complete Response

Secondary outcome:

Proportion of Patients With no Vomiting

Proportion of Patients Without Emetic Episodes

Proportion of Patients Without Antiemetic Rescue Medication

Proportion of Patients Without Nausea (Patient Aged > 6 Years)


Minimum age: N/A. Maximum age: 16 Years. Gender(s): Both.


Inclusion Criteria:

- Male or female patient aged from full term neonate to less than 17 years.

- In-patient or out-patient scheduled to undergo one of the following procedures:

- ear, nose and throat surgery (e. g., tonsillectomy, adenoidectomy, myringotomy),

- eye surgery (e. g. strabismus, vitreoretinal, cataract surgery),

- urological surgery (e. g. orchidopexy, varicocoele),

- plastic reconstructive surgery (e. g. cleft lip/cleft palate, burn procedures

involving the scalp),

- hernia repair,

- orthopedic surgery (e. g. foot and ankle deformities, arthroscopic surgeries, ACL


- cardiac surgery,

- neurosurgery.

- Patient is scheduled to undergo surgery requiring general intravenous anesthesia

- Patient is scheduled to receive nitrous oxide during the maintenance phase of


- Patient weighs at least 3. 2 kg

- ASA physical status I, II or III

- Fertile patients (male or female) must use reliable contraceptive measures

- Female patients who have attained menarche must have a negative pregnancy test at the

screening visit (Visit 1) and at study treatment visit (Visit 2)

- For patients with known hepatic impairment: in the Investigator's opinion, the

impairment does not jeopardize the patient's safety during the study

- For patients with known renal impairment: in the Investigator's opinion, the

impairment does not jeopardize the patient's safety during the study Exclusion Criteria:

- Lactating females

- Patient aged ≤6 years who received any investigational drug within 90 days prior to

Day 1, or patient aged >6 years who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion.

- Patient having participated in any previous trial with palonosetron.

- History of allergy to any components or any other contraindications to the use of any

5-HT3 receptor antagonists

- Patient to undergo emergency surgery

- Patient scheduled to receive regional anesthesia (lumbar, epidural, spinal) alone or

in conjunction with general intravenous anesthesia

- Patient scheduled to receive laryngeal mask anesthesia

- Patient scheduled to receive propofol during the maintenance phase of anesthesia

- Patient suffering from any concomitant disease uncontrolled by therapy, which, in the

judgment of the Investigator, could compromise the outcome of surgery

- Patient with history of gastro-esophageal reflux (except for patients up to 12


- Patient with ongoing vomiting from any organic cause

- Patient having experienced any vomiting, retching, or nausea within 24 hours prior to

the administration of the study drug

Locations and Contacts

CEMIC, Otorhinolaryngology Department, Buenos Aires C1431FWO, Argentina

Istituto Medico Rio Cuarto, Rio Cuarto X5800AEV, Argentina

University Hospital Brno - Children's Medical Centre, Brno 61300, Czech Republic

University Hospital Hradec Kralove, Hradec Kralove 500 05, Czech Republic

University Hospital Olomouc, Olomouc 775 20, Czech Republic

University Hospital Pilsen- Paediatric Clinic, Plzen-Lochotin 30460, Czech Republic

University Hospital Motol, Praha 15006, Czech Republic

Hospital Znojmo, State-Funded Organisation, Department of Pediatrics, Znojmo 669 02, Czech Republic

Semmeleis University, Budapest 1083, Hungary

St Istvan and St Laszlo Corporate Hospital; Paediatric Intensive Care Unit, Budapest 1097, Hungary

The Municipal Council's St Janos Hospital and North Buda United Hospitals; Central Anaesthesiology and Intensive Care Unit, Budapest 1125, Hungary

St Panthaleon Hospital; Central Department of Anaesthesiology and Intensive Care Unit, Dunaújváros 2400, Hungary

Pandy Kalman County Hospital; Department of Central Anaesthesiology and Intensive Care Unit, Gyula 5700, Hungary

Department of Pediatric Surgery and Urology of Medical University of Gdansk, Gdansk 80-803, Poland

Department of Pediatric Anesthesiology and Intensive Care, Lodz 91-738, Poland

Department of Pediatric Anesthesiology and Intensive Care, Lublin 20-093, Poland

Department of Intensive Care and Anesthesiology, Olsztyn 10-561, Poland

Department of Pediatric Surgery, Wroclaw 50-369, Poland

University Pediatric Hospital, San Juan PR 00936, Puerto Rico

State Healthcare Institution Arkhangelsk Regional Children's Hospital, Arkhangelsk 132002, Russian Federation

Federal State Institution: St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the MoH Care and Social Development of the Russian Federation, Saint Petersburg 190013, Russian Federation

International Clinic MEDEM, Saint Petersburg 191025, Russian Federation

St. Petersburg State Pediatric Medical Academy, St-Petersburg 194100, Russian Federation

Yaroslavl Region State Healthcare Institution, Yaroslavl 150042, Russian Federation

Dnipropetrovsk Regional Childrens Clinical Hospital, Dnipropetrovsk 49100, Ukraine

Regional Childrens Clinical Hospital, Donetsk 83052, Ukraine

Ivano-Frankivsk Regional Childrens Clinical Hospital, Ivano-Frankivsk 76000, Ukraine

City Clinical Hospital n#30, Kharkiv 61000, Ukraine

National Specialized Childrens Hospital OKHMATDYT, Kyiv 01135, Ukraine

Research and Development Center for Prophylactic and Clinical Medicine, Kyiv 01133, Ukraine

V.P. Filatov Institute of Eye Diseases and Tissue Therapy, Odesa 65061, Ukraine

Zaporizhia Regional Clinical Childrens Hospital, Zaporizhia 69000, Ukraine

Shoals Clinical Research Associates, Florence, Alabama 35630, United States

Shoals Medical Research, LLC, Sheffield, Alabama 35660, United States

Georgetown University Hospital, Washington DC, District of Columbia 20007, United States

Bascom Palmer Eye Institute - University of Miami, Miami, Florida 33136, United States

Louisiana State University Health Sciences Center, Shreveport, Louisiana 71103, United States

CRC of Jackson, Jackson, Mississippi 39202, United States

Cooper University Hospital, Camden, New Jersey 08103, United States

The University of North Carolina Hospitals, Chapel Hill, North Carolina 27599, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

Clinical Trial Developers, Cincinnati, Ohio 45255, United States

Texas Orthopedic Specialist, P.A, Grapevine, Texas 76051, United States

Memorial Hermann Hospital, Houston, Texas 77030, United States

Additional Information

Starting date: June 2011
Last updated: July 29, 2014

Page last updated: August 23, 2015

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