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

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ClinicalTrials.gov Identifier: NCT01218568
Recruitment Status : Completed
First Posted : October 11, 2010
Last Update Posted : April 4, 2013
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India

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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Drug: Rifaximin plus lactulose Drug: Lactulose Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial
Study Start Date : October 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rifaximin plus lactulose Drug: Rifaximin plus lactulose
Rifaximin 400 mg three times a day Lactulose 30-60 ml in two or three divided doses.
Active Comparator: lactulose
30-60ml/day
Drug: Lactulose
Lactulose 30-60 ml in two or three divided doses.



Primary Outcome Measures :
  1. Reversal of hepatic encephalopathy [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Death [ Time Frame: 10 days ]
  2. duration of hospital stay [ Time Frame: 10 days ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01218568


Locations
India
Institute of Liver & Biliary Sciences (ILBS)
New Delhi, Delhi, India, 110 070
Sponsors and Collaborators
Institute of Liver and Biliary Sciences, India

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01218568     History of Changes
Other Study ID Numbers: ILBS HE-01
First Posted: October 11, 2010    Key Record Dates
Last Update Posted: April 4, 2013
Last Verified: June 2012

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Rifaximin
Rifamycins
Lactulose
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents