Clinical Trial Results:
Open label clinical trial to determine the blood ethanol concentration following repeated administration of Bronchicum Elixir to children (1 to 12 years) with acute bronchitis.
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Summary
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EudraCT number |
2009-014904-73 |
Trial protocol |
DE |
Global end of trial date |
01 Dec 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
02 May 2025
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First version publication date |
02 May 2025
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Other versions |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
CAS/K/00409
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Cassella-med GmbH & Co. KG
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Sponsor organisation address |
Gereonsmuehlengasse 1, Cologne, Germany, 50670
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Public contact |
Clinical Operations, Cassella-med GmbH & Co.KG, clinical.operations@klosterfrau.de
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Scientific contact |
Clinical Operations, Cassella-med GmbH & Co.KG, clinical.operations@klosterfrau.de
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Apr 2011
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
01 Dec 2010
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Global end of trial reached? |
Yes
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Global end of trial date |
01 Dec 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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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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Protection of trial subjects |
Each subject (depending on age) and their legal guardians were fully informed of all aspects of the study and provided informed consent prior to start of any study procedures. Subjects and/or their legal guardians could withdraw from treatment at any time and for any reason. No specific additional measures were required to minimize distress given the nature of study.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Mar 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Germany: 16
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Worldwide total number of subjects |
16
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EEA total number of subjects |
16
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
3
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Children (2-11 years) |
13
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
All patients came from the patient pool of the investigator's practice. | |||||||||
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Pre-assignment
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Screening details |
Subjects were eligible for inclusion, if the main criteria were met: -acute illness for a maximum of 48 hours; - Bronchitis Severity Score (BSS) ≥ 5 points; - infants and children aged 1 to 12 years; - the custodial parent(s) give their written informed consent | |||||||||
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Period 1
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Period 1 title |
overall (overall period)
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Is this the baseline period? |
Yes | |||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Age Group I (1-4 years old) | |||||||||
Arm description |
- | |||||||||
Arm type |
age | |||||||||
Investigational medicinal product name |
Bronchicum Elixir
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral liquid
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Routes of administration |
Oral use
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Dosage and administration details |
2.5 ml six times a day
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Arm title
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Age Group II (5-12 years old) | |||||||||
Arm description |
- | |||||||||
Arm type |
age | |||||||||
Investigational medicinal product name |
Bronchicum Elixier
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral liquid
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Routes of administration |
Oral use
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Dosage and administration details |
7.5 ml four times a day
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Baseline characteristics reporting groups
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Reporting group title |
Age Group I (1-4 years old)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Age Group II (5-12 years old)
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
ITT
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Subject analysis set type |
Intention-to-treat | ||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
The ITT set consists of all subjects who were randomized and applied at least one dose of study medication. For this study all subjects were included in the safety analysis.
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End points reporting groups
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Reporting group title |
Age Group I (1-4 years old)
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Reporting group description |
- | ||
Reporting group title |
Age Group II (5-12 years old)
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Reporting group description |
- | ||
Subject analysis set title |
ITT
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
The ITT set consists of all subjects who were randomized and applied at least one dose of study medication. For this study all subjects were included in the safety analysis.
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End point title |
Blood alcohol determination (after 45 min) | ||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At the second visit, each patient was given the prescribed dose of Bronchicum Elixir for the age group and a blood sample was taken after 45 minutes.
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Statistical analysis title |
95% confidence intervals (tolerance ranges) | ||||||||||||
Statistical analysis description |
exploratively examined and descriptively analyzed
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Comparison groups |
Age Group I (1-4 years old) v Age Group II (5-12 years old)
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Number of subjects included in analysis |
14
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Analysis specification |
Pre-specified
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Analysis type |
other | ||||||||||||
P-value |
≤ 0.05 | ||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||
Confidence interval |
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End point title |
Bronchitis Severity Score (BSS) - relative reduction to V1 | ||||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
Determination of the therapeutic effect of the investigational product in acute bronchitis by comparing the Bronchitis Severity Score at V1 and V3
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
V1 (Day 1) to V3 (Day 7-9)
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
unknown | ||||||||||||||||||||||||||||||||||||||
Dictionary version |
0
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Reporting groups
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Reporting group title |
Intention to treat
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Reporting group description |
- | ||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
