At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 40 enrolled
Drug / intervention
400 mg Rifamycin SV dosage +2 moredrug
Likely dose
400 mg Rifamycin SV dosagefrom 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.
Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea. A Pilot, Dose Finding, Double-blind, Randomized, Multicentre Study
In Brief
A Phase 2 clinical trial evaluating 400 mg Rifamycin SV dosage, 800 mg Rifamycin SV dosage, and 1 other intervention for Infectious Diarrhoea. Completed, enrolled 40 participants.
Detailed Summary
To assess the safety and the preliminary efficacy data on the three doses of the new Cosmo Technologies oral rifamycin SV colon-release 200 mg tablets manufactured according to MMX technology (CB-01-11) in the treatment of infectious diarrhoea.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfectious Diarrhoea
Countries--
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
Primary CompletionJul 2008
First PostedFeb 2018
TodayJul 2026
First PostedFeb 27, 2018
Enrollment StartFeb 1, 2008
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 8.3 years ago
Interventions
400 mg Rifamycin SV dosagedrug
800 mg Rifamycin SV dosagedrug
1200 mg Rifamycin SV dosagedrug