E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
The primary aim of study is to determine PK and PD of levobupivacaine in newborns (premature included). And discover or decline of LA cumulation. The secondary aim of the study is to obtain enough information about decrease of opiate doses, occurrence of side effects of c-CELA, occurrence of tolerance, hyperalgesia and withdrawal syndrome associated with opiates. |
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E.1.1.1 | Medical condition in easily understood language |
This clinical trial aims to determine PK model of levobupivacaine in mature and premature neonates. Patient will be thoroughly observed during the using c-CELA in order to detect possible action. |
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E.1.1.2 | Therapeutic area | Health Care [N] - Population Characteristics [N01] |
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 |
The primary aim of study is to determine PK and PD of levobupivacaine in newborns (premature included). And discover or decline of LA cumulation. |
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E.2.2 | Secondary objectives of the trial |
The secondary aim of the study is to obtain enough information about decrease of opiate doses, occurrence of side effects of c-CELA, occurrence of tolerance, hyperalgesia and withdrawal syndrome associated with opiates. That could be a base for possibly following study or meta-analysis comparing use of c-CELA and opiates and show benefits of c-CELA and clarify its influence on opiate AE incidence and perhaps outcome of critically ill newborns. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects fulfilling following criteria will be enrolled into the study during the 2 years time period. ● Obtained informed consent of parent(s)/legal representative(s) ● Age younger than 45th week of PMA ● Previous or planned operation with great demand on POPM ● Other diseases demanding great POPM (even without any need of surgery) ● Vital functions of the patient will be stable and there will be no suspicion, that patient current condition might be worsen by insertion of c-CELA (every patient will be discussed with attending physician ) |
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E.4 | Principal exclusion criteria |
● Decline of informed consent by parent(s) legal representative ● Age older than 45th week of PMA ● Congenital malformation of caudal part of spine ( spina bifida oculta , meningocele, meningomyelocele) ● Disease or congenital malformation significantly restricting liver functions (Elevation of liver enzymes more than twice above the physiological range of the corresponding PMA) ● Disease or congenital malformation significantly restricting kidney functions (Elevation of urea and creatinine enzymes more than twice above the physiological range of the corresponding PMA) ● Clinical condition, which doesn’t long-term POPM ● Meningism ● Patients with proven withdrawal syndrome caused by opiate administration ● High risk of bleeding during insertion (coagulopathy) ● Severe anemia, which would lead to blood transfusion due to taking of blood samples |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary aim of study is to determine PK and PD of levobupivacaine in newborns (premature included). And discover or decline of LA cumulation. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
The secondary aim of the study is to obtain enough information about decrease of opiate doses, occurrence of side effects of c-CELA, occurrence of tolerance, hyperalgesia and withdrawal syndrome associated with opiates. That could be a base for possibly following study or meta-analysis comparing use of c-CELA and opiates and show benefits of c-CELA and clarify its influence on opiate AE incidence and perhaps outcome of critically ill newborns. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
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 | No |
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 | 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 | No |
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 | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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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Based on secondary end-point criteria until 5 years or before 5 years of follow-up |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |