E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Evaluate the efficacy of a single palonosetron IV dose to prevent postoperative nausea and vomiting through 24 hours. Evaluate the safety and tolerability of IV palonosetron in pediatric patients.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036238 |
E.1.2 | Term | Postoperative vomiting |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036285 |
E.1.2 | Term | Postoperative nausea |
E.1.2 | System Organ Class | 10022117 - Injury, poisoning and procedural complications |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to evaluate the safety and tolerability of IV palonosetron in pediatric patients. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 full term neonates up 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.Fertile patients (male or female) must use reliable contraceptive measures (such measures, for patients and sexual partners, include: implants, injectables, combined oral contraceptives, intrauterine devices, double-barrier methods, vasectomized/sterilized partner or sexual abstinence) 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint is the proportion of patients showing CR during the first 24 hours starting as soon as the patient wakes up and is able to show any active reaction postoperatively. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
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E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 16 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The planned duration of the study is a maximum of 32 days. Subjects with ongoing AEs at the follow-up visit and subjects who have an SAE within 30 days after study drug administration will be followed as necessary until the AE or SAE resolves or stabilizes. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |
E.8.9.2 | In all countries concerned by the trial days | 0 |