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Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea. A Pilot, Dose Finding, Double-blind, Randomized, Multicentre Study
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.
Details
| Lead sponsor | Cosmo Technologies Ltd |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 40 |
| Start date | 2008-02 |
| Completion | 2008-07 |
Conditions
- Infectious Diarrhoea
Interventions
- 400 mg Rifamycin SV dosage
- 800 mg Rifamycin SV dosage
- 1200 mg Rifamycin SV dosage
Primary outcomes
- Time to Last Unformed Stool (TLUS) — Up to 7 days
The safety and preliminary efficacy data of the three doses of the new rifamycin SV formulation tested based upon the time elapsed from the ingestion of the 1st dose of study medication to the passage of the last unformed stool (TLUS)