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Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis - Article


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Lactulose

Cephulac; Cholac; Chronulac; Constilac; Constulose; Duphalac; Enulose 




Clinical Trial: Phase II Study of Lactulose and Circadian Rhythms in Patients with Cirrhosis

This study has been completed.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
Northwestern University
Information provided by: Office of Rare Diseases (ORD)

Purpose

OBJECTIVES: I. Assess the effect of lactulose on the circadian rhythm of plasma melatonin in patients with subclinical hepatic encephalopathy. II. Assess the intrasubject variability of circadian melatonin levels and neuropsychological tests. III. Assess which elements of the neuropsychological test battery show the response to lactulose.

Condition Treatment or Intervention Phase
Portal Hypertension
Hepatic Encephalopathy
Cirrhosis
 Drug: lactulose
Phase II

MedlinePlus related topics:  Brain Diseases;   Liver Diseases;   Metabolic Disorders

Study Type: Interventional
Study Design: Treatment

Further Study Details: 

Expected Total Enrollment:  16

Study start: November 1994;  Study completion: February 1997

PROTOCOL OUTLINE: Patients are alternately assigned to 1 of 2 treatment groups: no therapy for 3 weeks followed by lactulose for 3 weeks versus lactulose for 3 weeks followed by no therapy for 3 weeks. A dietician advises patients on a 1 g/kg per day protein diet. The lactulose dose is adjusted to result in 2 or 3 loose bowel movements per day.

Eligibility

Ages Eligible for Study:  up to  64 Years,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

--Patient Characteristics--

  • Age: Under 65
  • Performance status: Not specified
  • Hematopoietic: Not specified
  • Hepatic: See Disease Characteristics
  • Renal: Not specified
  • Other: No alcohol intake within 1 month prior to entry No requirement for beta blockers No requirement for corticosteroids Not in intercontinental travel

Location Information

Study chairs or principal investigators

Andres Blei,  Study Chair,  Northwestern University   

More Information

Study ID Numbers:  199/11934; NU-523
Record last reviewed:  February 1998
Last Updated:  October 13, 2004
Record first received:  February 24, 2000
ClinicalTrials.gov Identifier:  NCT00004796
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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December 3, 2009



Page Updated: June 1, 2005
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