NCT01175538

Brief Summary

To assess the effects of lactulose for the prevention of first episode of altered sensorium (hepatic encephalopathy, primary prophylaxis) in patients with cirrhosis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2008

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2010

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

August 5, 2010

Status Verified

October 1, 2009

Enrollment Period

2.4 years

First QC Date

August 2, 2010

Last Update Submit

August 4, 2010

Conditions

Hepatic Encephalopathy

Keywords

Hepatic encephalopathyLactulose

Outcome Measures

Primary Outcomes (1)

  • prevention of first episode of hepatic encephalopathy

    6 months

Secondary Outcomes (1)

  • Side effects to lactulose and mortality

    6 months

Study Arms (1)

Lactulose

EXPERIMENTAL
Drug: Lactulose

Interventions

LactuloseDRUG

In the Gp-L group, patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passes 2-3 semisoft stools per day

Lactulose

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cirrhotic patients(18-70yrs) who never had encephalopathy

You may not qualify if:

  • history of taking lactulose in the past 6 weeks
  • alcohol intake during the past 6 weeks
  • hepatocellular carcinoma
  • previous TIPS or shunt surgery
  • significant co morbid illness such as heart, respiratory, or renal failure
  • neurologic diseases such as alzheimer's disease, parkinson's disease and nonhepatic metabolic encephalopathies.
  • patients on psychoactive drugs such as antidepressants or sedatives
  • who restarted alcohol during follow up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

G B Pant Hospital

New Delhi, National Capital Territory of Delhi, 110002, India

RECRUITING

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Lactulose

Condition Hierarchy (Ancestors)

Liver FailureHepatic InsufficiencyLiver DiseasesDigestive System DiseasesBrain Diseases, MetabolicBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

DisaccharidesOligosaccharidesPolysaccharidesCarbohydratesSugars

Study Officials

  • Barjesh C Sharma, MD,DM

    G B Pant Hospital New Delhi 110002

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Barjesh C Sharma, MD,DM

CONTACT

9718599203drbcsharma@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Purpose
TREATMENT
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 2, 2010

First Posted

August 5, 2010

Study Start

January 1, 2008

Primary Completion

June 1, 2010

Study Completion

September 1, 2010

Last Updated

August 5, 2010

Record last verified: 2009-10

Locations

IN(1)