Infectious Diarrhoea Clinical Trial
Official title:
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.
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 MMXTM
technology (CB-01-11) in the treatment of infectious diarrhoea.
Primary end points to determine:
• 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), in compliance with the relevant
guidelines
Secondary end-points to determine:
- The number of patients showing improvement in diarrhoea during a 24-h interval, i.e. >50
% reduction of bowel movements.
- The number of unformed stools passed per 24-h interval, after dosing.
- The number of patients who are declared to be "well". Wellness is defined as the patient
having 48 hours with no unformed stools, a maximum of two soft stools and no clinical
symptoms of infectious diarrhoea.
- The number of treatment failures. A treatment failure is defined as clinical
deterioration or worsening of symptoms or illness continuing after 120 h following the
first dose.
- The number and percentage of patients recovered from diarrhoea. Patients were considered
to have recovered if fewer than three unformed stools were passed in the previous 24
hours and no symptom of enteric infection were present.
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