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NCT01842581 · ClinicalTrials.gov registry record · Phase 4
The Safety/Efficacy of Rifaximin With/Without Lactulose in Participants With A History of Recurrent Hepatic Encephalopathy
A Phase 4 study of Cirrhosis and Hepatic Encephalopathy, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 4
- Development phase
- 222
- Enrollment target
- 20
- Study locations
NCT01842581 is a Phase 4 study of Cirrhosis and Hepatic Encephalopathy that has completed, run by Bausch Health Americas. The registered enrollment target is 222 participants, below the 90,405-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The trial reports 20 study locations across 10 states.
The verdict
NCT01842581, a Phase 4 study of Cirrhosis and Hepatic Encephalopathy, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 222 participants
- Enrollment target
- 20
- Study locations
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.
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 222 participants |
| Start Date | 2013-01-08 |
| Est. Completion | 2014-12-17 |
| Phase | Phase 4 |
Interested in This 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, categorized as Phase 4. The registered enrollment target is 222 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 90,405-participant average among 53 other Cirrhosis trials with a reported enrollment target (100% lower). The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.
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.
NCT01842581 reports 20 study locations spanning 10 distinct geographic areas - top geographies include California, Colorado, Florida.
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.
What interventions are being tested in trial NCT01842581?
The interventions under investigation include: Rifaximin (DRUG), Lactulose (DRUG).
Who is sponsoring clinical trial NCT01842581?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.