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

NCT ID: NCT01395901

Last Updated: 2014-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 670 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-04-30

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.

Conditions

Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Palonosetron and placebo to Ondansetron

Intervention: Drug: Palonosetron

Group Type: EXPERIMENTAL

Palonosetron

Intervention Type: DRUG

Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)

Placebo to Ondansetron

Intervention Type: DRUG

Ondansetron and placebo to Palonosetron

Intervention: Drug: Comparator: Ondansetron

Group Type: ACTIVE_COMPARATOR

Ondansetron

Intervention Type: DRUG

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 Palonosetron

Intervention Type: DRUG

Interventions

Palonosetron

Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)

Intervention Type: DRUG

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

Intervention Type: DRUG

Placebo to Ondansetron

Intervention Type: DRUG

Placebo to Palonosetron

Intervention Type: DRUG

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

• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helsinn Healthcare SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Shoals Clinical Research Associates

Florence, Alabama, United States

Shoals Medical Research, LLC

Sheffield, Alabama, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Bascom Palmer Eye Institute - University of Miami

Miami, Florida, United States

Louisiana State University Health Sciences Center

Shreveport, Louisiana, United States

CRC of Jackson

Jackson, Mississippi, United States

Cooper University Hospital

Camden, New Jersey, United States

The University of North Carolina Hospitals

Chapel Hill, North Carolina, United States

Duke University Medical Center

Durham, North Carolina, United States

Clinical Trial Developers

Cincinnati, Ohio, United States

Texas Orthopedic Specialist, P.A

Grapevine, Texas, United States

Memorial Hermann Hospital

Houston, Texas, United States

CEMIC, Otorhinolaryngology Department

Buenos Aires, , Argentina

Istituto Medico Rio Cuarto

Río Cuarto, , Argentina

University Hospital Brno - Children's Medical Centre

Brno, , Czechia

University Hospital Hradec Kralove

Hradec Králové, , Czechia

University Hospital Olomouc

Olomouc, , Czechia

University Hospital Pilsen- Paediatric Clinic

Plzen-Lochotin, , Czechia

University Hospital Motol

Prague, , Czechia

Hospital Znojmo, State-Funded Organisation, Department of Pediatrics

Znojmo, , Czechia

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, , Hungary

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, , Poland

University Pediatric Hospital

San Juan, , Puerto Rico

State Healthcare Institution Arkhangelsk Regional Children's Hospital

Arkhangelsk, , Russia

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, , Russia

International Clinic MEDEM

Saint Petersburg, , Russia

St. Petersburg State Pediatric Medical Academy

Saint Petersburg, , Russia

Yaroslavl Region State Healthcare Institution

Yaroslavl, , Russia

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

Research and Development Center for Prophylactic and Clinical Medicine

Kyiv, , Ukraine

National Specialized Childrens Hospital OKHMATDYT

Kyiv, , Ukraine

V.P. Filatov Institute of Eye Diseases and Tissue Therapy

Odesa, , Ukraine

Zaporizhia Regional Clinical Childrens Hospital

Zaporizhia, , Ukraine

Countries

United States; Argentina; Czechia; Hungary; Poland; Puerto Rico; Russia; Ukraine

Other Identifiers

PALO-10-14

Identifier Type: -

Identifier Source: org_study_id