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

NCT01218568 | Completed DMC

• 1 other identifier: ILBS HE-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• Reversal of hepatic encephalopathy

  10 days

Secondary Outcomes (2)

• Death

  10 days

• duration of hospital stay

  10 days

Study Arms (2)

Rifaximin plus lactulose

EXPERIMENTAL

Drug: Rifaximin plus lactulose

lactulose

ACTIVE COMPARATOR

30-60ml/day

Drug: Lactulose

Interventions

Rifaximin plus lactulose DRUG

Rifaximin 400 mg three times a day Lactulose 30-60 ml in two or three divided doses.

Rifaximin plus lactulose

Lactulose DRUG

Lactulose 30-60 ml in two or three divided doses.

lactulose

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhosis
• Age 18-80
• Hepatic encephalopathy grade II-IV
• Informed consent

You may not qualify if:

• Degenerative CNS disease or major psychiatric illness
• Serum creatinine \> 1.5 mg/dl
• Active alcohol intake \<4 weeks prior to present episode
• Others metabolic encephalopathies
• Hepatocellular Carcinoma
• Severe comorbidity such as CHF, Pulmonary disease, Neurological \& Psychiatric problems impairing quality of life

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences (ILBS)

New Delhi, National Capital Territory of Delhi, 110 070, India

Location

MeSH Terms

Conditions

Hepatic Encephalopathy

Interventions

Rifaximin; Lactulose

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2010
• First Posted: October 11, 2010
• Study Start: October 1, 2010
• Primary Completion: September 1, 2012
• Study Completion: October 1, 2012
• Last Updated: April 4, 2013

Record last verified: 2012-06

Locations

IN (1)