E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 determine the relation within a subject between the time to manual detection of the reappearance of T4 measured using a peripheral nerve stimulator and the time to recovery of the T4/T1 ratio to 0.9 measured using a TOF-Watch® SX, of 4.0 mg.kg-1 sugammadex administered at 15 minutes after either a bolus dose of 0.6 mg.kg-1 rocuronium or the last maintenance dose of 0.15 mg.kg-1 rocuronium. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female subjects: • of ASA Class 1 or 2 or 3; • between the ages of 18 to 64 years, inclusive; • scheduled for a surgical procedure under general anesthesia requiring neuromuscular relaxation with the use of rocuronium; • scheduled for a surgical procedures in supine position; • who have given written informed consent.
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E.4 | Principal exclusion criteria |
• Subjects in whom a difficult intubation because of anatomical malformations is expected; • Subjects known or suspected to have neuromuscular disorders impairing neuromuscular blockade and/or significant hepatic and/or renal dysfunction; • Subjects with a medical or physical condition that is expected to interfere with the proper conduct of simultaneous neuromuscular monitoring on both arms; • Subjects known or suspected to have a (family) history of malignant hyperthermia; • Subjects known or suspected to have arthritis or another disease that will cause the thumb not to move freely; • Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anesthesia; • Subjects receiving medication in a dose and/or at a time point known to interfere with NMBAs, such as antibiotics, anticonvulsants and Mg2+; • Subjects who have already participated in a sugammadex trial; • Subjects who have participated in another clinical trial, not pre-approved by NV Organon, within 30 days of entering into CT 19.4.313; • Female subjects who are pregnant*; • Female subjects who are breast-feeding.
* In female subjects pregnancy will be excluded both from medical history and by an hCG test within 24 hours before surgery except in females who are not of childbearing potential, i.e. at least 2 years menopausal or have undergone tubal ligation or an hysterectomy.
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E.5 End points |
E.5.1 | Primary end point(s) |
• Time from start administration of 4.0 mg.kg-1 sugammadex to recovery of the T4/T1 ratio to 0.9 (TOF-Watch® SX); • Time from start administration of 4.0 mg.kg-1 sugammadex to reappearance of T4 (Peripheral Nerve Stimulator). Note: The relation between these two times will be determined within subjects.
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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 | No |
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 | No |
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 |
peripheral nerve stimulator assessor blind |
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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 |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
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 | |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 5 |