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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier:
NCT01218568
First received: October 5, 2010
Last updated: April 2, 2013
Last verified: June 2012
  Purpose

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 Intervention
Hepatic Encephalopathy
Drug: Rifaximin plus lactulose
Drug: Lactulose

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Rifaximin Plus Lactulose Versus Lactulose Alone for the Treatment of Hepatic Encephalopathy: a Double Blind Randomized Trial

Resource links provided by NLM:


Further study details as provided by Institute of Liver and Biliary Sciences, India:

Primary Outcome Measures:
  • Reversal of hepatic encephalopathy [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Death [ Time Frame: 10 days ] [ Designated as safety issue: No ]
  • duration of hospital stay [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Enrollment: 120
Study Start Date: October 2010
Study Completion Date: October 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Institute of Liver and Biliary Sciences, India
ClinicalTrials.gov Identifier: NCT01218568     History of Changes
Other Study ID Numbers: ILBS HE-01
Study First Received: October 5, 2010
Last Updated: April 2, 2013
Health Authority: India: Ministry of Health

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
Lactulose
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 18, 2014