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Efficacy and Safety of CB-01-11 200mg Tablets in Infectious Diarrhoea

NCT03447821 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-02-18

Study results available
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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.

Conditions

  • Infectious Diarrhoea

Interventions

DRUG

400 mg Rifamycin SV dosage

DRUG

800 mg Rifamycin SV dosage

DRUG

1200 mg Rifamycin SV dosage

Sponsors & Collaborators

  • Cosmo Technologies Ltd

    lead INDUSTRY

Principal Investigators

  • Manuel Mancera Reyes · HOSPITAL CENTRAL DE ORIENTE

  • Can Polat Eyigün · Gülhane Military Medical Academy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-02-29
Primary Completion
2008-07-31
Completion
2008-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03447821 on ClinicalTrials.gov