Clinical trial NCT01395901: Safety and Efficacy of Palonosetron IV to Prevent Postoperative Nausea and Vomiting in Pediatric Patients
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Postoperative Nausea and Vomiting
Keywords: Prevention of Postoperative Nausea and Vomiting
Palonosetron
Ondansetron
Pediatric
Lead sponsor: Helsinn Healthcare SA
Sponsor class: INDUSTRY
First posted: 2011-07-18
Enrollment: 670
Sex: ALL
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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 surgery),.
  * 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 anesthesia
* 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 months)
* 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

Primary outcomes:
measure: Proportion of Patients With Complete Response
timeFrame: 0-24 hours after T0
Secondary outcomes:
measure: Proportion of Patients With no Vomiting
timeFrame: 0-24 hours after T0
measure: Proportion of Patients Without Emetic Episodes
timeFrame: 0-24 hours after T0
measure: Proportion of Patients Without Antiemetic Rescue Medication
timeFrame: 0-24 hours after T0
measure: Proportion of Patients Without Nausea (Patient Aged > 6 Years)
timeFrame: 0-24 hours after T0
Other outcomes:
Locations:
city: Florence
country: United States
facility: Shoals Clinical Research Associates
state: Alabama
city: Sheffield
country: United States
facility: Shoals Medical Research, LLC
state: Alabama
city: Washington DC
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Miami
country: United States
facility: Bascom Palmer Eye Institute - University of Miami
state: Florida
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center
state: Louisiana
city: Jackson
country: United States
facility: CRC of Jackson
state: Mississippi
city: Camden
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Chapel Hill
country: United States
facility: The University of North Carolina Hospitals
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: Clinical Trial Developers
state: Ohio
city: Grapevine
country: United States
facility: Texas Orthopedic Specialist, P.A
state: Texas
city: Houston
country: United States
facility: Memorial Hermann Hospital
state: Texas
city: Buenos Aires
country: Argentina
facility: CEMIC, Otorhinolaryngology Department
city: Rio Cuarto
country: Argentina
facility: Istituto Medico Rio Cuarto
city: Brno
country: Czech Republic
facility: University Hospital Brno - Children's Medical Centre
city: Hradec Kralove
country: Czech Republic
facility: University Hospital Hradec Kralove
city: Olomouc
country: Czech Republic
facility: University Hospital Olomouc
city: Plzen-Lochotin
country: Czech Republic
facility: University Hospital Pilsen- Paediatric Clinic
city: Praha
country: Czech Republic
facility: University Hospital Motol
city: Znojmo
country: Czech Republic
facility: Hospital Znojmo, State-Funded Organisation, Department of Pediatrics
city: Budapest
country: Hungary
facility: Semmeleis University
city: Budapest
country: Hungary
facility: St Istvan and St Laszlo Corporate Hospital; Paediatric Intensive Care Unit
city: Budapest
country: Hungary
facility: The Municipal Council's St Janos Hospital and North Buda United Hospitals; Central Anaesthesiology and Intensive Care Unit
city: Dunaújváros
country: Hungary
facility: St Panthaleon Hospital; Central Department of Anaesthesiology and Intensive Care Unit
city: Gyula
country: Hungary
facility: Pandy Kalman County Hospital; Department of Central Anaesthesiology and Intensive Care Unit
city: Gdansk
country: Poland
facility: Department of Pediatric Surgery and Urology of Medical University of Gdansk
city: Lodz
country: Poland
facility: Department of Pediatric Anesthesiology and Intensive Care
city: Lublin
country: Poland
facility: Department of Pediatric Anesthesiology and Intensive Care
city: Olsztyn
country: Poland
facility: Department of Intensive Care and Anesthesiology
city: Wroclaw
country: Poland
facility: Department of Pediatric Surgery
city: San Juan
country: Puerto Rico
facility: University Pediatric Hospital
city: Arkhangelsk
country: Russian Federation
facility: State Healthcare Institution Arkhangelsk Regional Children's Hospital
city: Saint Petersburg
country: Russian Federation
facility: Federal State Institution: St. Petersburg Research Institute of Ear, Throat, Nose and Speech under the MoH Care and Social Development of the Russian Federation
city: Saint Petersburg
country: Russian Federation
facility: International Clinic MEDEM
city: St-Petersburg
country: Russian Federation
facility: St. Petersburg State Pediatric Medical Academy
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Region State Healthcare Institution
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk Regional Childrens Clinical Hospital
city: Donetsk
country: Ukraine
facility: Regional Childrens Clinical Hospital
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk Regional Childrens Clinical Hospital
city: Kharkiv
country: Ukraine
facility: City Clinical Hospital n#30
city: Kyiv
country: Ukraine
facility: Research and Development Center for Prophylactic and Clinical Medicine
city: Kyiv
country: Ukraine
facility: National Specialized Childrens Hospital OKHMATDYT
city: Odesa
country: Ukraine
facility: V.P. Filatov Institute of Eye Diseases and Tissue Therapy
city: Zaporizhia
country: Ukraine
facility: Zaporizhia Regional Clinical Childrens Hospital
Study officials:
References: