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

Postoperative Nausea and Vomiting Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01395901
• Other study ID #: PALO-10-14
• Status: Completed
• Phase: Phase 3
• First received: July 14, 2011
• Last updated: July 29, 2014
• Start date: June 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2014
• Source: Helsinn Healthcare SA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationHungary: National Institute of PharmacyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsCzech Republic: State Institute for Drug ControlUkraine: Ministry of HealthRussia: Ministry of Health of the Russian FederationArgentina: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 670
• Est. completion date: April 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Argentina	CEMIC, Otorhinolaryngology Department	Buenos Aires
Argentina	Istituto Medico Rio Cuarto	Rio Cuarto
Czech Republic	University Hospital Brno - Children's Medical Centre	Brno
Czech Republic	University Hospital Hradec Kralove	Hradec Kralove
Czech Republic	University Hospital Olomouc	Olomouc
Czech Republic	University Hospital Pilsen- Paediatric Clinic	Plzen-Lochotin
Czech Republic	University Hospital Motol	Praha
Czech Republic	Hospital Znojmo, State-Funded Organisation, Department of Pediatrics	Znojmo
Hungary	Semmeleis University	Budapest
Hungary	St Istvan and St Laszlo Corporate Hospital; Paediatric Intensive Care Unit	Budapest
Hungary	The Municipal Council's St Janos Hospital and North Buda United Hospitals; Central Anaesthesiology and Intensive Care Unit	Budapest
Hungary	St Panthaleon Hospital; Central Department of Anaesthesiology and Intensive Care Unit	Dunaújváros
Hungary	Pandy Kalman County Hospital; Department of Central Anaesthesiology and Intensive Care Unit	Gyula
Poland	Department of Pediatric Surgery and Urology of Medical University of Gdansk	Gdansk
Poland	Department of Pediatric Anesthesiology and Intensive Care	Lodz
Poland	Department of Pediatric Anesthesiology and Intensive Care	Lublin
Poland	Department of Intensive Care and Anesthesiology	Olsztyn
Poland	Department of Pediatric Surgery	Wroclaw
Puerto Rico	University Pediatric Hospital	San Juan
Russian Federation	State Healthcare Institution Arkhangelsk Regional Children's Hospital	Arkhangelsk
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
Russian Federation	International Clinic MEDEM	Saint Petersburg
Russian Federation	St. Petersburg State Pediatric Medical Academy	St-Petersburg
Russian Federation	Yaroslavl Region State Healthcare Institution	Yaroslavl
Ukraine	Dnipropetrovsk Regional Childrens Clinical Hospital	Dnipropetrovsk
Ukraine	Regional Childrens Clinical Hospital	Donetsk
Ukraine	Ivano-Frankivsk Regional Childrens Clinical Hospital	Ivano-Frankivsk
Ukraine	City Clinical Hospital n#30	Kharkiv
Ukraine	National Specialized Childrens Hospital OKHMATDYT	Kyiv
Ukraine	Research and Development Center for Prophylactic and Clinical Medicine	Kyiv
Ukraine	V.P. Filatov Institute of Eye Diseases and Tissue Therapy	Odesa
Ukraine	Zaporizhia Regional Clinical Childrens Hospital	Zaporizhia
United States	Cooper University Hospital	Camden	New Jersey
United States	The University of North Carolina Hospitals	Chapel Hill	North Carolina
United States	Clinical Trial Developers	Cincinnati	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	Shoals Clinical Research Associates	Florence	Alabama
United States	Texas Orthopedic Specialist, P.A	Grapevine	Texas
United States	Memorial Hermann Hospital	Houston	Texas
United States	CRC of Jackson	Jackson	Mississippi
United States	Bascom Palmer Eye Institute - University of Miami	Miami	Florida
United States	Shoals Medical Research, LLC	Sheffield	Alabama
United States	Louisiana State University Health Sciences Center	Shreveport	Louisiana
United States	Georgetown University Hospital	Washington DC	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Helsinn Healthcare SA

Countries where clinical trial is conducted

United States,  Argentina,  Czech Republic,  Hungary,  Poland,  Puerto Rico,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of Patients With Complete Response	Complete Response was defined as no vomiting, no retching, and no use of antiemetic rescue medication during the first 24 hours postoperatively, starting at T0. Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.	0-24 hours after T0	No
Secondary	Proportion of Patients With no Vomiting	Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.	0-24 hours after T0	No
Secondary	Proportion of Patients Without Emetic Episodes	An emetic episode was defined as one or more continuous vomits (expulsion of stomach contents through the mouth) or retches (an attempt to vomit that is not productive of stomach contents). Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.	0-24 hours after T0	No
Secondary	Proportion of Patients Without Antiemetic Rescue Medication	Rescue medications are any medications with potential antiemetic effect taken in the 24 hours after patient wake-up from anaesthesia (T0).Time 0 (T0) was defined as the time when the patient wakes up and is able to show any active reaction postoperatively.	0-24 hours after T0	No
Secondary	Proportion of Patients Without Nausea (Patient Aged > 6 Years)		0-24 hours after T0	No