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NCT01218568 Clinical Trial

Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial

Hepatic Encephalopathy Clinical Trial

Official title:
Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01218568
Other study ID # ILBS HE-01
Secondary ID
Status Completed
Phase N/A
First received October 5, 2010
Last updated April 2, 2013
Start date October 2010
Est. completion date October 2012

Study information
Verified date June 2012
Source Institute of Liver and Biliary Sciences, India
Contact n/a
Is FDA regulated No
Health authority India: Ministry of Health
Study type Interventional

Clinical Trial Summary

The study will be double blind with respect to rifaximin, and randomization will be performed using tables of computer-generated random numbers. All subjects will be followed up till the recovery of HE (primary end point) or 10 days whichever is earlier. In the Lactulose group (group A) patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passes 2-3 semisoft stools per day along with placebo . In the lactulose plus rifaximin group (group B) patients will receive cap rifaximin 400mg three times a day along with lactulose. Primary endpoints will be recovery of overt HE patients who will not recover from HE after 10 days will be continued on the same treatment. Total duration of the study is 1 year.

Recruitment information / eligibility
Status Completed
Enrollment 120
Est. completion date October 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Cirrhosis

- Age 18-80

- Hepatic encephalopathy grade II-IV

- Informed consent

Exclusion Criteria:

1. Degenerative CNS disease or major psychiatric illness

2. Serum creatinine > 1.5 mg/dl

3. Active alcohol intake <4 weeks prior to present episode

4. Others metabolic encephalopathies

5. Hepatocellular Carcinoma

6. Severe comorbidity such as CHF, Pulmonary disease, Neurological & Psychiatric problems impairing quality of life

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Rifaximin plus lactulose
Rifaximin 400 mg three times a day Lactulose 30-60 ml in two or three divided doses.
• Lactulose
Lactulose 30-60 ml in two or three divided doses.

Locations
Country Name City State
India Institute of Liver & Biliary Sciences (ILBS) New Delhi Delhi

Sponsors (1)
Lead Sponsor Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reversal of hepatic encephalopathy 10 days No
Secondary Death 10 days No
Secondary duration of hospital stay 10 days No
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