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

Condition(s) targeted: Postoperative Nausea and Vomiting

Intervention: Palonosetron (Drug); Ondansetron (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Helsinn Healthcare SA

Overall contact:
Ludmila Telizhenko, MD, Phone: +38 044 492 8560, Ext: 4250, Email: Ludmila.Telizhenko@psi-cro.com

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.

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 (no vomiting, no retching, and no use of rescue medication) during the first 24 hours after Time 0 (T0)

Secondary outcome: Other efficacy endpoints:

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

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

Ludmila Telizhenko, MD, Phone: +38 044 492 8560, Ext: 4250, Email: Ludmila.Telizhenko@psi-cro.com

University Hospital Hradec Kralove, Hradec Kralove 500 05, Czech Republic; Not yet recruiting
Viktor Chrobok, MD, Principal Investigator

University Hospital Olomouc, Olomouc 775 20, Czech Republic; Recruiting
Vladimir Mihal, MD, Principal Investigator

Hospital Znojmo, State-Funded Organisation, Department of Pediatrics, Znojmo 669 02, Czech Republic; Recruiting
Petr Bloudicek, MD, Principal Investigator

St Istvan and St Laszlo Corporate Hospital; Paediatric Intensive Care Unit, Budapest 1097, Hungary; Recruiting
Enikö Ujhelyi, MD, Principal Investigator

The Municipal Council's St Janos Hospital and North Buda United Hospitals; Central Anaesthesiology and Intensive Care Unit, Budapest 1125, Hungary; Recruiting
Tibor Nyulasi, MD, Principal Investigator

Semmeleis University, Budapest 1083, Hungary; Recruiting
Balàzs Szabo, MD, Principal Investigator

St Panthaleon Hospital; Central Department of Anaesthesiology and Intensive Care Unit, Dunaújváros 2400, Hungary; Recruiting
Lajos Jobbágy, MD, Principal Investigator

Pandy Kalman County Hospital; Department of Central Anaesthesiology and Intensive Care Unit, Gyula 5700, Hungary; Recruiting
Attila Havas, MD, Principal Investigator

Department of Pediatric Surgery and Urology of Medical University of Gdansk, Gdansk 80-803, Poland; Recruiting
Piotr Czauderna, MD, Principal Investigator

Department of Pediatric Anesthesiology and Intensive Care, Lodz 91-738, Poland; Recruiting
Andrzej Piotrowski, MD, Principal Investigator

Department of Pediatric Anesthesiology and Intensive Care, Lublin 20-093, Poland; Recruiting
Witold Lesiuk, MD, Principal Investigator

Department of Intensive Care and Anesthesiology, Olsztyn 10-561, Poland; Recruiting
Maria Dziejowska, MD, Principal Investigator

Department of Pediatric Surgery, Wroclaw 50-369, Poland; Recruiting
Dariusz Patkowski, MD, Principal Investigator

University Pediatric Hospital, San Juan PR 00936, Puerto Rico; Recruiting
Miguel Marrero, MD, Principal Investigator

Shoals Clinical Research Associates, Florence, Alabama 35630, United States; Recruiting
David Boyer, MD, Principal Investigator

Shoals Medical Research, LLC, Sheffield, Alabama 35660, United States; Recruiting
Tim Melson, MD, Principal Investigator

Jackson Memorial Hospital University of Miami, Miami, Florida 33136, United States; Not yet recruiting
Keith Candiotti, MD, Principal Investigator

CRC of Jackson, Jackson, Mississippi 39202, United States; Recruiting
Scott Berry, MD, Principal Investigator

Cooper University Hospital, Camden, New Jersey 08103, United States; Recruiting
Bharathi Gourkanti, MD, Principal Investigator

Clinical Trial Developers, Cincinnati, Ohio 45255, United States; Not yet recruiting
Michael Lee, MD, Principal Investigator

Texas Orthopedic Specialist, P.A, Grapevine, Texas 76051, United States; Recruiting
Howard W. Harris, MD, Principal Investigator

Memorial Hermann Hospital, Houston, Texas 77030, United States; Recruiting
Samia Khalil, MD, Principal Investigator

Starting date: June 2011
Last updated: November 7, 2011