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Spores of Bacillus Clausii Probiotic Strain

Phase 3

Diarrhea | Small molecule | Gastrointestinal |Sanofi|Last Updated: Jan 11, 2011

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment420
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00265369TEDDY: Spores of Bacillus Clausii in Acute Diarrhoea in ChildrenPHASE3 COMPLETED 420 — — May 1, 2004 -Jan 11, 20112 Belgium, France
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Study Endpoints
Primary Endpoints
Duration of diarrhoea as counted from the first intake of the investigational product up to the first appearance of a loose stool followed by two-consecutive normal stools
Secondary Endpoints
Number of infants/children with normal stools at D3, D4, D5, D6 and D7;Mean number of stools per day;Occurrence of vomiting episodes per day after enrolment;Parents'overall global assessment of efficacy at the end of the treatment;other safety criteria
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
Spores of Bacillus Clausii Probiotic StrainDRUG -
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Eligibility Criteria
Age Range6 Months — 36 Months
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion criteria: Infants or Children * Non hospitalized infants or children * With acute diarrhea evident for less than 48 hours * Having had three or more watery stools during the preceding 24 hours Exclusion criteria: Infants or Children * With blood stools * Having been treated with antib...

Countries:BelgiumFrance
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