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Acetyl-L-Carnitine In Severe Hepatic Encephalopathy

This study has been completed.
Sponsor:
Information provided by:
University of Catania
ClinicalTrials.gov Identifier:
NCT01223768
First received: October 18, 2010
Last updated: NA
Last verified: December 2000
History: No changes posted

October 18, 2010
October 18, 2010
July 2002
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No Changes Posted
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Acetyl-L-Carnitine In Severe Hepatic Encephalopathy
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To assess the clinical efficacy of ALC in the treatment of severe hepatic encephalopathy (grade 3 of the West Haven grading scale), we performed a randomised, double blind placebo-controlled study administering ALC to cirrhotic patients, evaluating the effects on ammonia levels and performance in cognitive functions.

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Interventional
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Hepatic Encephalopathy (Grade 3 of the West Haven Grading Scale)
  • Drug: Acetyl-l-Carnitine
    2g per day
  • Drug: placebo
    twice per day
  • Experimental: Acetyl-L-carnitine
    Intervention: Drug: Acetyl-l-Carnitine
  • Placebo Comparator: placebo
    Intervention: Drug: placebo
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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December 2005
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Inclusion Criteria:

  • patients with severe hepatic encephalopathy (grade 3 of the West Haven grading scale) with hepatic cirrhosis

Exclusion Criteria:

  • Patients with a history of recent alcohol abuse, patients using psychotropic drugs (e.g., antipsychotics, interferon, benzodiazepines, anti-epileptics, sedatives and antidepressants)
  • Other exclusion criteria were the following: major complications of portal hypertension, such as gastrointestinal blood loss, hepatorenal syndrome or bacterial peritonitis; acute superimposed liver injury;patients with metabolic disorders such as diabetes mellitus, unbalanced heart failure and/or respiratory failure or end-stage renal disease; any additional precipitating factors such as high protein intake (additional high-protein meals), constipation; illiteracy.
Both
40 Years to 65 Years
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Contact information is only displayed when the study is recruiting subjects
Italy
 
NCT01223768
8-12-00 C
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University of Catania
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University of Catania
December 2000

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP