Alcoholic liver disease in patients hospitalised for alcohol detoxification.
Conditions
Interventions
Trade Name: Distraneurin(R) Mixtur
Pharmaceutical Form: Oral solution
Current Sponsor code: 6083948.00.00
Other descriptive name: CLOMETHIAZOLE
Concentration unit: mg/ml milligram(s)/millilitre
Concen
Sponsors
KRANKENHAUS SALEM DER EVANG. STADTMISSION HEIDELBERG GGMBH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 7.3 Inclusion criteria 1. Age: 18–70 years 2. Ability to understand and willingness to comply with study interventions and restrictions. 3. Voluntarily signed informed consent after full explanation of the study to the participant. 4. Diagnosis of alcohol addiction as defined by ICD-10 5. Hospital admission for alcohol detoxification 6. ASAT >ULN 7. Females of child bearing potential are only included if using reliable contraception with a Pearl Index =65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 7.4 Exclusion criteria 1. Advanced liver disease (liver cirrhosis) or Fibroscan >12kPa 2. Hemoglobin <10 g/dl 3. Uncontrolled diabetes mellitus (defined as fasting blood glucose =200 mg/dl) 4. Significant uncontrolled cardiovascular disease or cardiac insufficiency (New York Heart Association [NYHA] classes III-IV) 5. Renal insufficiency (creatinine clearance calculated with Cockcroft & Gault formula =30 ml/min) 6. Therapy with drugs that act as inhibitors or inducers of CYP2E1 (except ethanol) in the last 14 days. 7. Any antibiotic therapy due to infections 2 weeks prior to first study drug administration 8. Major surgery =4 weeks prior to first study drug administration or ongoing side effects of such surgery 9. Any active systemic infection 10. Systemic diseases (cardiovascular, renal, hepatic, etc.) that would prevent study treatment 11. Allergies (except for mild forms of hay fever) or history of hypersensitivity reactions 12. Any other acute illness or clinically relevant findings in the pre-study examination that could interfere with the patient’s safety or study objectives according to the investigator’s judgement. 13. Treatment with a systemic investigational compound within 28 days prior to the screening visit 14. Inability to communicate well with the investigator due to language problems or poor mental development 15. Contraindication against clomethiazole, chlorazepate, chlorzoxazone or known intolerance of one of the substances or their additives 16. For female participants: pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 4.1Objectives The study objective is to assess whether clomethiazole has a favourable effect on the recovery from alcoholic liver damage. Because long-term clomethiazole intake may be addictive (Fachinformation Distraneurin®), it can only be given for a short time for alcohol detoxification. Thus the effect of clomethiazole can only be assessed for the period of hospitalisation covering the usual treatment period (~ 5-12 days) for the detoxification of alcoholics (Majumdar SK. Drug Alcohol Depend 1991;27:201-7). 4.2Criteria to be studied The following parameters will be studied at hospital admission, after 1, after 10 (5-12), and after 30 days: 1.Transaminases (ASAT, ALAT) ;Secondary Objective: 2.Liver fat content measured via controlled attenuation parameter (CAP) 3.Liver stiffness measured with Fibroscan® 4.Changes in CYP2E1 activity 5.Changes in biomarkers of liver damage such as hyaluronate ;Primary end point(s): Changes in ASAT;Timepoint(s) of evaluation of this end point: at admission, every two days, at discharge and | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Changes in ALAT 3. Changes in liver fat content 4. Changes in liver stiffness 5. Changes in other function parameters (INR, albumin, bilirubin) 6. Changes in chlorzoxazone pharmacokinetics (AUC0-8, t1/2, clearance, hydroxylation index, metabolic ratio 2 h and 4 h post dose) 7. Duration of hospitalisation;Timepoint(s) of evaluation of this end point: at admission, at discharge and after 30 days. | — |
Countries
Germany
Contacts
Public ContactDept. of Internal Medicine
Salem Medical Center
Outcome results
None listed