670
Participants
Start Date
June 30, 2011
Primary Completion Date
March 31, 2012
Study Completion Date
April 30, 2012
Palonosetron
Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
Ondansetron
"Single dose Ondansetron IV:~* 0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for \>40 kg;~* 13 years to less than 17 years dose: 4 mg"
Placebo to Ondansetron
Placebo to Palonosetron
Semmeleis University, Budapest
St Istvan and St Laszlo Corporate Hospital; Paediatric Intensive Care Unit, Budapest
The Municipal Council's St Janos Hospital and North Buda United Hospitals; Central Anaesthesiology and Intensive Care Unit, Budapest
St Panthaleon Hospital; Central Department of Anaesthesiology and Intensive Care Unit, Dunaújváros
Pandy Kalman County Hospital; Department of Central Anaesthesiology and Intensive Care Unit, Gyula
University Hospital Motol, Prague
Georgetown University Hospital, Washington D.C.
The University of North Carolina Hospitals, Chapel Hill
Duke University Medical Center, Durham
University Hospital Pilsen- Paediatric Clinic, Plzen-Lochotin
Bascom Palmer Eye Institute - University of Miami, Miami
Shoals Clinical Research Associates, Florence
Shoals Medical Research, LLC, Sheffield
CRC of Jackson, Jackson
Clinical Trial Developers, Cincinnati
Dnipropetrovsk Regional Childrens Clinical Hospital, Dnipropetrovsk
City Clinical Hospital n#30, Kharkiv
University Hospital Brno - Children's Medical Centre, Brno
V.P. Filatov Institute of Eye Diseases and Tissue Therapy, Odesa
Zaporizhia Regional Clinical Childrens Hospital, Zaporizhia
Louisiana State University Health Sciences Center, Shreveport
Ivano-Frankivsk Regional Childrens Clinical Hospital, Ivano-Frankivsk
Texas Orthopedic Specialist, P.A, Grapevine
Memorial Hermann Hospital, Houston
Regional Childrens Clinical Hospital, Donetsk
State Healthcare Institution Arkhangelsk Regional Children's Hospital, Arkhangelsk
Yaroslavl Region State Healthcare Institution, Yaroslavl
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
International Clinic MEDEM, Saint Petersburg
St. Petersburg State Pediatric Medical Academy, Saint Petersburg
Cooper University Hospital, Camden
CEMIC, Otorhinolaryngology Department, Buenos Aires
Istituto Medico Rio Cuarto, Río Cuarto
University Hospital Hradec Kralove, Hradec Králové
University Hospital Olomouc, Olomouc
Hospital Znojmo, State-Funded Organisation, Department of Pediatrics, Znojmo
Department of Pediatric Surgery and Urology of Medical University of Gdansk, Gdansk
Department of Pediatric Anesthesiology and Intensive Care, Lodz
Department of Pediatric Anesthesiology and Intensive Care, Lublin
Department of Intensive Care and Anesthesiology, Olsztyn
Department of Pediatric Surgery, Wroclaw
University Pediatric Hospital, San Juan
Research and Development Center for Prophylactic and Clinical Medicine, Kyiv
National Specialized Childrens Hospital OKHMATDYT, Kyiv
Lead Sponsor
Helsinn Healthcare SA
INDUSTRY