Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 4

The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy

NCT01842581 · View on ClinicalTrials.gov ↗

Study Summary

The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.

Interventions

  • DRUG Rifaximin
  • DRUG Lactulose

Study Locations (20)

California

  • Southern California Liver Centers — Coronado
  • UCSF/Fresno - CRMC — Fresno
  • UCSD Clinical & Translational Research Institute — La Jolla
  • Salix Site — Long Beach
  • Inland Empire Liver Foundation — Rialto
  • Salix Site — Riverside
  • Salix Site — San Diego
  • Salix Site — San Francisco

Colorado

  • University of Colorado Denver — Aurora
  • South Denver GI — Englewood

Florida

  • University of Florida Hepatology — Gainesville
  • Tampa General Medical Group — Tampa

Louisiana

  • Salix Site — Jefferson
  • Delta Research Partners, LLC — Monroe

Arizona

  • Banner Research — Phoenix

Georgia

  • Gastroenterology Associates — Macon

Illinois

  • Salix Site — Chicago

Indiana

  • Indiana University — Indianapolis

Trial Details

FieldValue
Enrollment Target 222 participants
Start Date 2013-01-08
Est. Completion 2014-12-17
Phase Phase 4

Sponsor

Bausch Health Americas

55 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01842581

The ClinicalTrials.gov registry entry for NCT01842581 describes a study currently listed as completed. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 55 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Cirrhosis appearing as the primary indexed condition, and to 2 interventions — of which Rifaximin is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01842581 reports 20 study locations spanning 10 distinct geographic areas — top geographies include California, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01842581 about?

NCT01842581 is a clinical study titled "The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy". The purpose of the study is to evaluate if rifaximin alone or rifaximin plus lactulose delays the onset of hepatic encephalopathy (HE) in participants with cirrhosis who have had a previous episode of HE.

What is the current status of trial NCT01842581?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 222 participants. The study started on 2013-01-08. Estimated completion is 2014-12-17.

What conditions does trial NCT01842581 study?

This clinical trial studies the following conditions: Cirrhosis, Hepatic Encephalopathy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01842581?

The interventions under investigation include: Rifaximin (DRUG), Lactulose (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01842581?

This trial is sponsored by Bausch Health Americas, which has 55 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01842581 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial