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 show the time to recovery from a neuromuscular blockade induced by rocuronium after reversal at 1-2 PTC by 4.0 mg.kg-1 sugammadex is within ten minutes in 95% of Chinese subjects undergoing elective surgery during profound neuromuscular blockade under propofol anesthesia. |
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E.2.2 | Secondary objectives of the trial |
- to show the time to recovery from a neuromuscular blockade induced by rocuronium after reversal at 1-2 PTC by 4.0 mg.kg-1 sugammadex is within ten minutes in 95% of Caucasian subjects undergoing elective surgery during profound neuromuscular blockade under propofol anesthesia; − to show equivalence in the time to recovery from rocuronium induced NMB after reversal at 1-2 PTC by 4.0 mg.kg-1 sugammadex in Chinese and Caucasian subjects undergoing elective surgery during profound neuromuscular blockade under propofol anesthesia; − to evaluate the safety of 4.0 mg.kg-1 sugammadex in subjects undergoing elective surgery during profound neuromuscular blockade under propofol anesthesia; |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Each subject must be willing and able to provide written informed consent for the trial. 2. Each subject must be ≥ 18 to ≤ 64 years of age. A subject may be of either sex. 3. For China only: Subjects of Chinese descent born in China, never emigrated out of China and have a Chinese home address. For Europe only: Subjects of Caucasian descent born in Europe, never emigrated out of Europe and have a European home address. 4. Each subject must be scheduled for elective surgery under general anesthesia, allowing stable neuromuscular monitoring, which requires profound neuromuscular blockade using rocuronium. 5. Each subject must be ASA class ≥ 1 to ≤ 3. 6. Each subject must be able to adhere to dose and visit schedules. 7. Each female subject (and male subject whose female partner also provides written informed consent to provide information regarding pregnancy) of child-bearing potential must agree to use an accepted method of contraception while receiving protocol-specified medication and for seven days after stopping the medication.
Accepted methods of contraception include contraceptive pills, intrauterine devices, contraceptive injections, subdermal implantation, vaginal ring, and transdermal patches and surgical sterilization (eg, hysterectomy or tubal ligation).
Postmenopausal women are not required to use contraception. Postmenopausal is defined as at least 12 consecutive months without a spontaneous menstrual period. |
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E.4 | Principal exclusion criteria |
1. A subject must not have anatomical malformations leading to an expected difficult intubation. 2. A subject must not have or is not suspected to have neuromuscular disorders affecting NMB. 3. A subject must not have or is not suspected to have a significant renal dysfunction that would prevent participation in this trial as determined by the investigator. 4. A subject must not have or is not suspected to have a significant hepatic dysfunction that would prevent participation in this trial as determined by the investigator. 5. A subject must not be scheduled for a surgery requiring the use of pneumatic tourniquet. 6. A subject must not have or is not suspected to have a (family) history of malignant hyperthermia. 7. A subject must not have or is not suspected to have an allergy to opioids, cyclodextrins (including sugammadex), muscle relaxants or their excipients or other medication used during general anesthesia. 8. A subject must not continue to receive any treatment listed in Table 1 (see protocol) during the current trial. 9. A female subject must not be breast-feeding. 10. A female subject must not be pregnant (pregnancy will be excluded for women both from medical history and by an hCG test (random urine or serum) within 24 hours before surgery, except for women who are not of childbearing potential, ie, at least one year menopausal (at least 12 consecutive months without a spontaneous menstrual period) or have undergone bilateral tubal ligation or bilateral oophorectomy or hysterectomy); or intending to become pregnant. 11. A subject must not have participated in this or a previous sugammadex trial. 12. A subject must not have participated in another investigational drug clinical trial within 30 days, inclusive, of signing the informed consent form of the current trial. 13. A subject must not have any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the trial evaluations or optimal participation in the trial. 14. A subject must not be a member or a family member of the personnel of the investigational or sponsor staff directly involved with this trial. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The time from start of administration of sugammadex to recovery of the T4/T1 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 | 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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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 | 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 | 12 |