E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
|
E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018061 |
E.1.2 | Term | General anesthesia |
E.1.2 | System Organ Class | 100000004865 |
|
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 evaluate the time interval between the end of administration of the Zemuron® intubating dose and the reappearance of T3 following one of three intubating doses of Zemuron® (0.45 mg/kg, 0.6 mg/kg, or 1.0 mg/kg) in term neonates (birth to <28 days old), infants (28 days to ≤3 months), toddlers (>3 months to ≤2 years old), children (>2 to ≤11 years of age), and adolescents (>11 to ≤17 years of age). |
|
E.2.2 | Secondary objectives of the trial |
1. To evaluate the time course of action (onset time, maximum block, reappearance of T1, and recovery to 70%, 80% and 90% T4/T1) following one of three intubating doses of Zemuron® (0.45 mg/kg, 0.6 mg/kg or 1.0 mg/kg) in term neonates, infants, toddlers, children, and adolescent subjects.
2. To evaluate the intubating conditions following one of three intubating doses of Zemuron® (0.45 mg/kg 0.6 mg/kg, or 1.0 mg/kg) in term neonates, infants, toddlers, children, and adolescent subjects.
3. To collect sparse samples for population pharmacokinetic analysis.
4. To evaluate safety data of three different intubating doses of Zemuron® (0.45 mg/kg, 0.6 mg/kg or 1.0 mg/kg). |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Males or non-pregnant, non-nursing females from birth to ≤17 years of age, and of ASA Class 1, 2 or 3 scheduled for surgery under general anesthesia. |
|
E.4 | Principal exclusion criteria |
Subjects were to be excluded if they were >17 years of age or preterm neonates (<37 weeks gestational age at birth); had congenital anomalies or airway obstructions that would have precluded visualization or intubation of the trachea; had known significant renal or hepatic disorders; had known or suspected of having neuromuscular disorder, personal or family history of malignant hyperthermia, allergy to narcotic analgesics, hypnotics, NMBAs or other medications used during general anesthesia; were receiving medications during the pre-trial period or were to be receiving medications during the in-trial period in a dosage known to modify the action of NMBAs; required the use of pneumatic tourniquet during the surgical procedure; participated as research subjects in another clinical trial not pre-approved by Organon within 30 days before this trial; had already participated in this trial; or if their parent(s) or legal guardian(s) were not willing to give written consent and where applicable, the subject had not given appropriate assent to participate. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Time to reappearance of T3 (time from end-administration of Zemuron to reappearance of the third twitch of a TOF stimulation) |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
Onset time, maximum block, time to reappearance of T1, Recovery to TOF 0.7, 0.8 and 0.9 and intubation score |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
|
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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
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 | Yes |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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 |
different doses of Esmeron |
|
E.8.2.4 | Number of treatment arms in the trial | 3 |
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 | No |
E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
|
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
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 7 |