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A multicenter, randomized, open-label, active- controlled, trial to evaluate the safety and efficacy of Rifaximin 550 mg with and without lactulose in subjects with a history of recurrent overt hepatic encephalopathy
Study for patients with with hepatic encephalopathy using drug, rifaximin
| Sponsor: | Salix Pharmaceuticals Inc. |
| Enrolling: | Male and Female Patients |
| Study Length: | 6 Months |
| Clinic Visits: | 9 |
| IRB Number: | AAAL3712 |
| U.S. Govt. ID: | NCT01846663 |
| Contact: | Theresa Lukose: 212-305-3839 / tt2103@columbia.edu |
Additional Study Information:
The purpose of this study is to compare the time to onset of an episode of overt HE, in subjects with previously demonstrated overt HE after treatment with rifaximin 550 mg BID and lactulose, or rifaximin 550 mg BID. Subjects will be screened to confirm eligibility into the study. Once confirmed, subjects will begin the treatment phase and will be randomly assigned to a group that receives 550 mg BID rifaximin or a group that receives 550 mg BID rifaximin + lactulose. After the screening process and randomization subjects will enter a 6 month treatment period receiving either one of the treatment drugs. Subjects will have a follow-up visit 14 days following their 6 month treatment period.
This study is closed
