Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004796
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase II Study of Lactulose and Circadian Rhythms in Patients With Cirrhosis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
1998-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 gkg per day protein diet The lactulose dose is adjusted to result in 2 or 3 loose bowel movements per day
A dietician advises patients on a 1 gkg per day protein diet The lactulose dose is adjusted to result in 2 or 3 loose bowel movements per day
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NU-523 | None | None | None |