ot applicable

• Conditions: Postoperative nausea and vomiting (PONV); MedDRA version: 14.0Level: LLTClassification code 10036238Term: Postoperative vomitingSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 14.0Level: LLTClassification code 10036285Term: Postoperative nauseaSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Diseases [C] - Injuries, poisonings, and occupational diseases [C21]

• Registration Number: EUCTR2010-022971-79-CZ
• Lead Sponsor: Helsinn Healthcare SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-22
• Last Update Posted: 2 June 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 660

Inclusion Criteria

1.Written informed consent to be signed by parent(s) of the pediatric patient in compliance with the local law regulations. In addition signed children’s assent form according to local requirements.
2.Male or female patient aged from 1 month to less than 17 years.
3.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.
4.Patient is scheduled to undergo surgery requiring general intravenous anesthesia.
5.Patient scheduled to receive nitrous oxide during the maintenance phase of anesthesia.
6.Patient weight at least 3.2 kg.
7.ASA physical status I, II or III.
8.Sexually active patients (male or female) must use double-barrier contraception method for patients and sexual partners.
9.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). The patient and her parent(s) must be counseled on the importance of not becoming pregnant before or during the study.
10.For patients with known hepatic impairment: in the investigator’s opinion the impairment does not jeopardize patient’s safety during the study.
11.For patients with known renal impairment: in the investigator’s opinion the impairment does not jeopardize patient’s safety during the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 660
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. The patient and/or parents/caregivers are expected by the Investigator to be non-compliant with the study procedures.
2. Lactating females.
3. Patient aged =6 years who received any investigational drug within 90 days prior to Day 1, or patient aged >6 who received any investigational drug within 30 days prior to Day 1 or is expected to receive investigational drugs prior to study completion.
4. Patient having participated in any previous trial with palonosetron.
5. History of allergy to any components or any other contraindications to the use of any 5-HT3 receptor antagonists.
6. Patient to undergo emergency surgery.
7. Patient scheduled to receive regional anesthesia (lumbar, epidural, spinal) alone or in conjunction with general intravenous anesthesia.
8. Patient scheduled to receive laryngeal mask anesthesia.
9. Patient scheduled to receive propofol during the maintenance phase of anesthesia.
10. Patient scheduled to receive intragastric tube in situ postoperatively.
11. Patient suffering from any concomitant disease uncontrolled by therapy, which, at the judgment of the Investigator, could compromise the outcome of surgery.
12. Patient with history of gastro-esophageal reflux (except for patients up to 12 months).
13. Patient with ongoing vomiting from any organic cause.
14. Patient having experienced any vomiting, retching, or nausea within 24 hours prior to the administration of the study drug.
15. Use of any of the following drug with potential anti-emetic effect within 48h prior to surgery (Appendix D):
• 5-HT3 antagonists (e.g., ondansetron, granisetron, dolasetron);
• Phenothiazines (e.g., perphenazine, prochlorperazine, promethazine, fluphenazine, chlorpromazine, thiethylperazine);
• Butyrophenones (e.g., droperidol, haloperidol);
• Benzamides (e.g., metoclopramide, alizapride);
• Systemic corticosteroids (e.g., dexamethasone, prednisone, methylprednisolone; except inhaled steroids for respiratory disorders and topical steroids for skin disease);
• Dimenhydrinate; hydroxyzine; domperidone; lorazepam; cyclizine; cannabinoids; scopolamine; trimetobenzamide HCl; meclizine hydrochloride; pseudoephedrine HCl;
• Over the Counter (OTC) antiemetics, OTC cold or OTC allergy medications;
• Herbal preparations containing ephedra or ginger.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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 1 month to less than 17 years undergoing elective surgical procedures requiring general intravenous anesthesia.;Secondary Objective: The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients.;Primary end point(s): Primary efficacy endpoint: Proportion of patients showing Complete Response (CR; defined as no vomiting, no retching, and no use of antiemetic rescue medication);Timepoint(s) of evaluation of this end point: during the first 24 hours, starting as soon as the patient wakes up and is able to show any active reaction postoperatively (e.g., respond to commands, speak, cry, lift head, open eyes or squeeze hand)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The secondary efficacy endpoints (0-24 hours) are:<br>• Proportion of patients with no vomiting<br>• Proportion of patients without emetic episodes<br>• Proportion of patients without antiemetic rescue medication<br>• Proportion of patients without nausea (patients aged = 6 years)<br>• Time to first vomiting<br>• Time to first emetic episode<br>• Time to first administration of rescue medication.<br>• Time to treatment failure (time to first emetic episode or time to first administration of rescue medication, whichever occur first);Timepoint(s) of evaluation of this end point: during the first 24 hours, starting as soon as the patient wakes up and is able to show any active reaction postoperatively (e.g., respond to commands, speak, cry, lift head, open eyes or squeeze hand)