At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 71 enrolled
Drug / intervention
40 mg Rifaximin SSD once daily +4 moredrug
Likely dose
40 mg Rifaximin SSD once dailyfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Multicenter Study to Assess the Efficacy and Safety of Rifaximin Soluble Solid Dispersion (SSD) Tablets Plus Lactulose for the Treatment of Overt Hepatic Encephalopathy (OHE)
In Brief
A Phase 2 clinical trial evaluating 40 mg Rifaximin SSD once daily, 40 mg Rifaximin SSD twice daily, and 3 other interventions for Overt Hepatic Encephalopathy. Completed, enrolled 71 participants across 34 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOvert Hepatic Encephalopathy
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedMay 2018
Enrollment StartSep 2018
Primary CompletionMar 2020
TodayJul 2026
First PostedMay 3, 2018
Enrollment StartSep 13, 2018
Primary CompletionMar 12, 2020
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 8.2 years ago
Interventions
40 mg Rifaximin SSD once dailydrug
SSD once daily (QD)
40 mg Rifaximin SSD twice dailydrug
SSD twice daily (BID)
80 mg Rifaximin SSD once dailydrug
SSD once daily (QD)
80 mg Rifaximin SSD twice dailydrug
SSD twice daily (BID)
Placebodrug
Administered twice daily (BID)