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NCT03515044 · ClinicalTrials.gov registry record · Phase 2

Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)

A Phase 2 study, sponsored by Bausch Health Americas.

Completed
Registry status
Phase 2
Development phase
71
Enrollment target

NCT03515044 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 71 participants.

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The verdict

NCT03515044, a Phase 2 study, has completed, sponsored by Bausch Health Americas.

COMPLETED
Registry status
Phase 2
Development phase
71 participants
Enrollment target

Study Summary

Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE).

Interventions

  • DRUG Placebo
  • DRUG 40 mg Rifaximin SSD once daily
  • DRUG 40 mg Rifaximin SSD twice daily
  • DRUG 80 mg Rifaximin SSD once daily
  • DRUG 80 mg Rifaximin SSD twice daily

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2018-09-13
Est. Completion 2020-03-12
Phase Phase 2

Sponsor

Bausch Health Americas

168 total trials

What the Registry Record Tells You About NCT03515044

The ClinicalTrials.gov registry entry for NCT03515044 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bausch Health Americas, which has 168 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.

NCT03515044 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT03515044 about?

NCT03515044 is a clinical study titled "Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)". Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE).

What is the current status of trial NCT03515044?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2018-09-13. Estimated completion is 2020-03-12.

What interventions are being tested in trial NCT03515044?

The interventions under investigation include: Placebo (DRUG), 40 mg Rifaximin SSD once daily (DRUG), 40 mg Rifaximin SSD twice daily (DRUG), 80 mg Rifaximin SSD once daily (DRUG), 80 mg Rifaximin SSD twice daily (DRUG).

Who is sponsoring clinical trial NCT03515044?

This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.

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

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.