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

Phase 1

• Conditions: Alcohol withdrawal symptomps; MedDRA version: 20.0Level: LLTClassification code 10001637Term: Alcoholic withdrawal symptomsSystem Organ Class: 100000004873; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2021-002188-23-DK
• Lead Sponsor: Bispebjerg Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-05-18
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 26

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

•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified