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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)
ClinicalTrials.gov Identifier: NCT00004796
  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 Intervention Phase
Portal Hypertension
Hepatic Encephalopathy
Cirrhosis
Drug: lactulose
Phase II

MedlinePlus related topics:   Cirrhosis    High Blood Pressure   

Drug Information available for:   Lactulose   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:   16
Study Start Date:   November 1994
Estimated Study Completion Date:   February 1997

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.

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004796

Sponsors and Collaborators

Investigators
Study Chair:     Andres Blei     Northwestern University    
  More Information


Study ID Numbers:   199/11934, NU-523
First Received:   February 24, 2000
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004796
Health Authority:   United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
cardiovascular and respiratory diseases  
cirrhosis  
gastrointestinal disorders  
hypertensive disorder
portal hypertension
rare disease

Study placed in the following topic categories:
Liver Failure
Liver Diseases
Metabolic Diseases
Gastrointestinal Diseases
Fibrosis
Respiration Disorders
Vascular Diseases
Rare Diseases
Central Nervous System Diseases
Liver Cirrhosis
Hypertension, Portal
Brain Diseases
Portal hypertension
Hepatic Encephalopathy
Digestive System Diseases
Metabolic disorder
Lactulose
Brain Diseases, Metabolic
Hypertension
Hepatic Insufficiency

Additional relevant MeSH terms:
Pathologic Processes
Therapeutic Uses
Nervous System Diseases
Gastrointestinal Agents
Cardiovascular Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on December 03, 2008




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