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pristinamycin

Phase 3

Tonsillitis | Small molecule | Other |Sanofi|Last Updated: Mar 17, 2009

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
RandomizedACTIVE_CONTROLLEDBiomarker
Total Trials1
Total Enrollment395
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00393744Efficacy Study of Pristinamycin Versus Amoxicillin to Treat Tonsillitis Induced by Streptococcus in ChildrenPHASE3 COMPLETED 395Oct 1, 2006 -Mar 17, 20091 France
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Study Endpoints
Primary Endpoints
bacterial eradication
at V3
Secondary Endpoints
adverse events
during the study
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
Interventions
NameTypeDescription
pristinamycinDRUG50 mg/kg/d in 2 doses for children, and 1g twice daily in adults for 4 days
amoxicillinDRUG50 mg/kg/d in 2 doses in children and 1 g twice daily in adults for 6 days
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Eligibility Criteria
Age Range6 Years — 25 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * subjects of both sexes * aged between 6 and 25 years, * weight : ≥ 20kg * with suspected GAS-induced tonsillitis (erythema and/or exudate of the pharynx and/or tonsils with oropharyngeal pain and/or odynophagia, fever ³ 38°C, appreciable satellite adenopathy) * confirmation by...

Countries:France
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