E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sugammadex is a selective relaxant binding agent, which is administered in case of a rocuronium-induced neuromuscular block, during general anaesthesia. The aim of the trial is to investigate the use, efficacy and safety of sugammadex in children (2-17 years) with moderate to severe renal failure (creatinine clearance < 30 ml/min), compared to children with normal renal function. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10038443 |
E.1.2 | Term | Renal failure and impairment |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009119 |
E.1.2 | Term | Chronic renal failure |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10014647 |
E.1.2 | Term | End stage renal failure |
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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 demonstrate the efficacy of sugammadex in reversing rocuronium-induced neuromuscular blockade in children with moderate to severe renal failure. |
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E.2.2 | Secondary objectives of the trial |
To demonstrate that sugammadex is safe to use in children with moderate to severe renal failure. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Children with ASA classification status II-III (renal failure) 2. Children with ASA classification status I-II (healthy controls) 3. Age: 2-17 years 4. Scheduled for elective surgical procedures under general anaesthesia, for which a single dose of rocuronium 0.6 mg/kg is needed for endotracheal intubation. 5. Scheduled for surgical procedures in the supine position. 6. Written Informed Consent. 7. Moderate to severe renal failure: creatinine clearance < 30 ml/min. 8. Healthy controls: creatinine clearance > 90 ml/min
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E.4 | Principal exclusion criteria |
1. Known or suspected neuromuscular disease. 2. Known or suspected malignant hyperthermia. 3. Known or suspected allergy to anaesthetics, muscle relaxants or other medication used during general anaesthesia. 4. Use of medication suspected to interfere with the action of sugammadex (flucloxacillin, fucidinic acid). 5. Use of medication known to interfere with the action of rocuronium (anti-epileptics, aminoglycoside antibriotics, magnesium). 6. Scheduled for outpatient procedures.
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E.5 End points |
E.5.1 | Primary end point(s) |
Time from start of administration of sugammadex to recovery of the TOF ratio to 0.9 |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
children with normal renal function, ASA I-II |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |