E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Prevention of Post-operative Nausea and Vomiting (PONV) in pediatric subjects |
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E.1.1.1 | Medical condition in easily understood language |
Prevention of Post-operative Nausea and Vomiting (PONV) in pediatric subjects |
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E.1.1.2 | Therapeutic area | Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10036901 |
E.1.2 | Term | Prophylaxis against postoperative nausea and vomiting |
E.1.2 | System Organ Class | 100000004865 |
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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 |
- To estimate the effectiveness of 2 dose levels of IV granisetron (20 μg/kg and 40 μg/kg) in preventing PONV defined as total control (no nausea, no vomiting, no use of rescue medication) during the 0-2 hour interval following time of extubation (end of surgery) in children aged 2-16. |
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E.2.2 | Secondary objectives of the trial |
- To estimate the effectiveness of 2 dose levels of IV granisetron (20 μg/kg and 40 μg/kg) in preventing PONV during the 24 hour interval following time of extubation in children aged 2-16, based on specified secondary endpoints.
- To examine the safety profile of IV granisetron in pediatric subjects undergoing tonsillectomy or adenotonsillectomy. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Males and females 2-16 years of age
- Scheduled to undergo elective surgery for tonsillectomy or adenotonsillectomy requiring general anesthesia and endotracheal intubation
- Scheduled for hospital admission for no longer than 24 hours |
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E.4 | Principal exclusion criteria |
- Known allergy or other contraindication to the use of Kytril or any of its components
- Known allergy to any other 5HT3 antagonist
- History of motion sickness or post-operative nausea or vomiting
- Nausea or vomiting in the 24 hours prior to anesthesia |
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E.5 End points |
E.5.1 | Primary end point(s) |
- Percentage of Participants With Total Control of Postoperative Nausea and Vomiting (PONV) Over the 2 hours Following Extubation |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
0-2 hour following extubation (end of surgery) on Day 1 |
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E.5.2 | Secondary end point(s) |
- Percentage of Participants With Total Control of Postoperative Nausea and Vomiting (PONV) Over the 24 hours Following Extubation
- Percentage of Participants With No Vomiting Over the 2 hours Following Extubation
- Percentage of Participants With Vomiting From the Time of Extubation Until Postanesthesia Care Unit (PACU) Discharge
- Percentage of Participants With No Vomiting Over the 24 hours Following Extubation
- Time to First Vomiting Episode
- Percentage of Participants With No Complaints of Nausea Over the 2 hours Following Extubation
- Percentage of Participants With No Complaints of Nausea From the Time of Extubation Until postanesthesia care unit (PACU) Discharge
- Percentage of Participants With No Complaints of Nausea Over the 24 hours Following Extubation
- Percentage of Participants With No Rescue Medication Use
- Time to First Use of Rescue Medication
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to 24 hours following extubation (end of surgery) on Day 1 unless otherwise indicated |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | No |
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.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
Will this trial be conducted at a single site globally?
| No |
E.8.4 | Will this trial be conducted at multiple sites globally? | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |