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.
|
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
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--
- Clinical diagnosis of cirrhosis with portal hypertension or portal-systemic shunting
--Prior/Concurrent Therapy--
- No concurrent therapy for hepatic encephalopathy
--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
Andres Blei, Study Chair, Northwestern University
More Information
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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