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Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00004796
Recruitment Status : Completed
First Posted : February 25, 2000
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Northwestern University
Information provided by:
Office of Rare Diseases (ORD)

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Portal Hypertension Hepatic Encephalopathy Cirrhosis Drug: lactulose Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 16 participants
Primary Purpose: Treatment
Study Start Date : November 1994
Study Completion Date : February 1997

Resource links provided by the National Library of Medicine

Drug Information available for: Lactulose

Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   0 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004796


Sponsors and Collaborators
National Center for Research Resources (NCRR)
Northwestern University
Investigators
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Study Chair: Andres Blei Northwestern University
More Information
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ClinicalTrials.gov Identifier: NCT00004796    
Other Study ID Numbers: 199/11934
NU-523
First Posted: February 25, 2000    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: February 1998
Keywords provided by Office of Rare Diseases (ORD):
cardiovascular and respiratory diseases
cirrhosis
gastrointestinal disorders
 hypertensive disorder
portal hypertension
rare disease
Additional relevant MeSH terms:
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Liver Cirrhosis
Hypertension, Portal
Hepatic Encephalopathy
Brain Diseases
Hypertension
Fibrosis
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
 Digestive System Diseases
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Brain Diseases, Metabolic
Metabolic Diseases
Lactulose
Gastrointestinal Agents