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NCT01904409 · ClinicalTrials.gov registry record · Phase 2
Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis
A Phase 2 study, sponsored by Bausch Health Americas.
- Completed
- Registry status
- Phase 2
- Development phase
- 420
- Enrollment target
NCT01904409 is a Phase 2 study that has completed, run by Bausch Health Americas. The registered enrollment target is 420 participants.
The verdict
NCT01904409, a Phase 2 study, has completed, sponsored by Bausch Health Americas.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 420 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess the efficacy of rifaximin SSD versus placebo in preventing complications of liver cirrhosis, such as all-cause mortality (death due to all causes) or hospitalization, in subjects with early decompensated liver cirrhosis. Rifaximin, a non-systemic antibacterial agent, is currently marketed as a 550 mg tablet for the reduction in risk of recurrent overt hepatic encephalopathy, a complication of liver cirrhosis. The rifaximin SSD tablet was formulated to maximize the efficacy of rifaximin. Subjects will receive 1 of 5 doses of rifaximin SSD tablets or placebo tablets every day for 24 weeks.
Interventions
- DRUG Placebo
- DRUG Rifaximin SSD 40 mg IR tablet
- DRUG Rifaximin SSD 80 mg IR tablet
- DRUG Rifaximin SSD 40 mg SER tablet
- DRUG Rifaximin SSD 80 mg SER tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 420 participants |
| Start Date | 2013-06 |
| Est. Completion | 2015-07 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01904409
The ClinicalTrials.gov registry entry for NCT01904409 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 420 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.
NCT01904409 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01904409 about?
NCT01904409 is a clinical study titled "Dose-ranging Study of Rifaximin Soluble Solid Dispersion (SSD) Tablets for the Prevention of Complications of Early Decompensated Liver Cirrhosis". The primary objective of this study is to assess the efficacy of rifaximin SSD versus placebo in preventing complications of liver cirrhosis, such as all-cause mortality (death due to all causes) or hospitalization, in subjects with early decompensated liver cirrhosis. Rifaximin, a non-systemic ant...
What is the current status of trial NCT01904409?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 420 participants. The study started on 2013-06. Estimated completion is 2015-07.
What interventions are being tested in trial NCT01904409?
The interventions under investigation include: Placebo (DRUG), Rifaximin SSD 40 mg IR tablet (DRUG), Rifaximin SSD 80 mg IR tablet (DRUG), Rifaximin SSD 40 mg SER tablet (DRUG), Rifaximin SSD 80 mg SER tablet (DRUG).
Who is sponsoring clinical trial NCT01904409?
This trial is sponsored by Bausch Health Americas, which has 168 total clinical trials registered on ClinicalTrials.gov.
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