Clinical Trial Results:
Association between variations in CYP pheno- and genotypes and plasma concentration of chlordiazepoxide in the treatment of alcohol withdrawal symptoms
Summary
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EudraCT number |
2021-002188-23 |
Trial protocol |
DK |
Global end of trial date |
11 Jun 2023
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Jun 2024
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First version publication date |
26 Jun 2024
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Other versions |
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 |
KLOPOXID2021
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Bispebjerg and Frederiksberg Hospital
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Sponsor organisation address |
Bispebjerg Bakke 23, opgang 20c st. th., København NV, Denmark, 2400
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Public contact |
Christian Sylvest Meyhoff, Bispebjerg and Frederiksberg Hospital, +45 24910542, christian.sylvest.meyhoff@regionh.dk
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Scientific contact |
Christian Sylvest Meyhoff, Bispebjerg and Frederiksberg Hospital, +45 24910542, christian.sylvest.meyhoff@regionh.dk
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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 |
21 May 2024
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
11 Jun 2023
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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 aim of this study is to elucidate if CYP phenotypes, variations in CYP genotypes and dose of
chlordiazepoxide are correlated to the concentration of chlordiazepoxide in patients admitted to ICU
or Intermediate Care Department (ICD) for respiratory insufficiency and/or agitation in relation to alcohol
withdrawal symptoms.
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Protection of trial subjects |
No specific measure were taken to protect trial subjects.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Aug 2021
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
Yes
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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 |
Denmark: 27
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Worldwide total number of subjects |
27
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EEA total number of subjects |
27
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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) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
18
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From 65 to 84 years |
8
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85 years and over |
1
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Recruitment
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Recruitment details |
Patients aged more than 18 years who had been treated with at least 200 mg of chlordizapoxide for alcohol withdrawal symptoms and were admitted to either ICU or HDU due to somnolence respiratory insufficiency or agitation were elligible for inclusion. Patients were included no later than 12 hours after ICU or HDU admittance. | ||||||||||
Pre-assignment
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Screening details |
Patients aged more than 18 years who had been treated with at least 200 mg of chlordizapoxide for alcohol withdrawal symptoms and were admitted to either ICU or HDU due to somnolence respiratory insufficiency or agitation were screened for inclusion. | ||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
Blinding implementation details |
Patients were not blinded.
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Arms
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Arm title
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Included | ||||||||||
Arm description |
treatment with chlordizapoxide preceeded inclusion. No intervention was performed during the study period. | ||||||||||
Arm type |
No Intervention | ||||||||||
Investigational medicinal product name |
No Product
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Chlordizepoxide was administered before inclusion in the study.
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Baseline characteristics reporting groups
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Reporting group title |
Overall trial
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Reporting group description |
- | |||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Included
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Reporting group description |
treatment with chlordizapoxide preceeded inclusion. No intervention was performed during the study period. |
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End point title |
plasma concentration of chlordiazepoxide [1] | ||||||||||||||||
End point description |
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End point type |
Primary
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End point timeframe |
At inclusion and 12 h after inclusion.
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: In this study there were no comparisons between arms. All patients were included after having recieved Chlordizepoxide. The study population was divided into two groups according to phenotypes. Phenotypes were analyzed after inclusion. Results are presented in tables under "Charts". |
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Attachments |
Pheno- and genotypes associated to plasma conc. Table 2. Association between CYP phenotypes and p- Table 3. Association between treatment with invasi |
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No statistical analyses for this end point |
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End point title |
Cumulative dose of chlordiazepoxide before admission to ICU/ICD | ||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
February 2023-june 2023
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Notes [2] - 825 [200 - 2100] median [5-95 Percentile] |
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No statistical analyses for this end point |
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End point title |
ICU length of stay (LOS) | ||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
February 2023-june 2023
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Notes [3] - ICU: 6.5 [1.8 - 17] ICU/HDU: 3.2 [1.5 - 18.4] median [5 - 95 percentile] |
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No statistical analyses for this end point |
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End point title |
Need for Invasive mechanical ventilation | ||||||||||
End point description |
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End point type |
Secondary
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End point timeframe |
February 2023-june 2023
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No statistical analyses for this end point |
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Adverse events information [1]
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Timeframe for reporting adverse events |
From inclusion until 12 h after inclusion
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
Meriam-Webster | ||||||||||||||||||||||||||||||||||
Dictionary version |
2024
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Reporting groups
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Reporting group title |
Overall study
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Reporting group description |
26 patients were included in the overall study. | ||||||||||||||||||||||||||||||||||
Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: Non serious adverse events were not recorded. Chlordiazepoxide was administered before inclusion in the study and was not administered during the 12 h study period. |
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||
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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 |