Correlation of dose, plasma concentration and effect of chlordiazepoxide and variations in CYP pheno- and genotypes in the treatment of alcohol withdrawal symptoms

Association between variations in CYP pheno- and genotypes and plasma concentration of chlordiazepoxide in the treatment of alcohol withdrawal symptoms

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2021-002188-23-DK

Enrollment

Registered

2021-05-18

Start date

2021-12-01

Completion date

Unknown

Last updated

2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol withdrawal symptomps MedDRA version: 20.0 Level: LLT Classification code 10001637 Term: Alcoholic withdrawal symptoms System Organ Class: 100000004873

Interventions

Trade Name: Klopoxid Product Name: Klopoxid Pharmaceutical Form: Tablet INN or Proposed INN: CHLORDIAZEPOXIDE CAS Number: 58-25-3 Concentration unit: mg milligram(s) Concentration type: range Concentr

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: • Age =18 years • Treatment with minimum 200 mg chlordiazepoxide for alcohol withdrawal symptoms during hospital admission • Acute admittance to ICU or ICD due to respiratory insufficiency, impaired consciousness or agitation. • Inclusion possible within 6 h of ICU/ICD admission Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: • Allergies to omeprazole and midazolam • Treatment with chlordiazepoxide within the first 12 h after inclusion (from blood samples at inclusion until blood samples 12 h after inclusion) • Treatment with omeprazole within 1 day prior to ICU/ICD admission • Treatment with midazolam within 1 day prior to ICU/ICD admission • Cardiac arrest prior to admission • Pregnancy

Design outcomes

Primary

Measure	Time frame
Main Objective: 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. ;Secondary Objective: Not applicable;Primary end point(s): The primary outcome is plasma concentration of chlordiazepoxide ;Timepoint(s) of evaluation of this end point: At inclusion and 12 h after inclusion	—

Measure

Time frame

Main Objective: 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. ;Secondary Objective: Not applicable;Primary end point(s): The primary outcome is plasma concentration of chlordiazepoxide ;Timepoint(s) of evaluation of this end point: At inclusion and 12 h after inclusion

—

Secondary

Measure	Time frame
Secondary end point(s): Cumulative dose of chlordiazepoxide before admission to ICU/ICD ICU length of stay (LOS) Need for mechanical ventilation ;Timepoint(s) of evaluation of this end point: February 2023-june 2023	—

Countries

Denmark

Contacts

Public ContactNanna Reiter

Bispebjerg Hospital

nanna.reiter@regionh.dk+4521939251

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026