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 |
The main objective of this open label clinical trial is to determine if blood ethanol concentration reaches a critical value (0,125‰) after repeated administration of a dose of the IMP to children in the age between 1 and 12 years. |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of this clinical trial are:
-To asses the efficacy of the IMP in reducing the severity of bronchitis symptoms using the Bronchitis Severity Score
-To evaluate the global efficacy and safety of the IMP by the investigator
-To evaluate the global efficacy and safety of the IMP by the patients /their parents
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria:
- children between the age of 1 and 12 years - diagnosis of acute bronchitis (according to bronchitis severity score, BSS ≥ 5) - written informed consent of the patient's parents to participate
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E.4 | Principal exclusion criteria |
Exclusion criteria:
- Obstructive or non-obstructive chronic bronchitis - Allergic bronchial asthma - Parallel treatment with antibiotics, glucocorticoids, beta-mimetics - theophylline, expectorants or antitussives or any treatment with this type of medication during 7 days before trial start (antibiotics: 4 weeks before trial start) - indication for treatment with antibiotics (fever of ≥ 39°C) - known sensitivity to the ingredients of the investigational product - pathological laboratory findings, any severe organ- or systemic disease - the exclusion of minors, who have been committed to a youth institution by official directive or judicial order. - simultaneous participation in another clinical trial or participation in a clinical trial during 4 weeks before start of this clinical trial - inability to comply with study protocol
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary endpoint: - proof that after administration of investigational product (0, 45 and 90 minutes post administration), blood ethanol concentration stays below the critical value of 0,125‰
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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End of trial is defined as last visit of last patient. |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |