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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: Completed Phase 2 study, sponsored by Bausch Health Americas.
NCT03515044 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 71 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
A participant was considered to have an overt HE episode if at least one of the following applied: (1) Disorientated to time or place or person, (2) Lethargic and has asterixis, (3) Inability to assess the patient due to disorientation to time and place and person; and/or somnolence, and/or coma. Severity of OHE episodes was graded using the HEGI scale, where Grade 1 is no clinical findings of OHE, and Grade 4 is comatose. Higher scores on the scale have higher severity (worse outcome).
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
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2018-09-13 |
| Est. Completion | 2020-03-12 |
| Phase | Phase 2 |
What the finished NCT03515044 record still lists
NCT03515044 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT03515044 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03515044's enrollment target sits among peer trials
71 936th of 2000 higher than 1,064 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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