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Amoxycillin

Phase 3

Non-Severe Pneumonia With Wheeze | Small molecule | Infectious Disease |United Therapeutics Corporation|Last Updated: Dec 5, 2006

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment2,000
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00407394Indiaclen Short Course Amoxycillin Therapy for Pneumonia With WheezePHASE3 COMPLETED 2,000 — — Apr 1, 2004Apr 1, 2006Dec 5, 20061 India
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Study Endpoints
Primary Endpoints
Clinical Cure: Respiratory rate below age specific cut-off (<50 bpm in infants <12 months and <40 bpm in 12 - 59 months of age).
Secondary Endpoints
Clinical failure: Any signs of severe pneumonia or severe disease; chest in drawing, convulsions, drowsiness or inability to drink at any time; Respiratory rate above age specific cut-off on day 4 or after that; Oxygen saturation on pulse oximetry <90%
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
AmoxycillinDRUG -
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Eligibility Criteria
Age Range2 Months — 59 Months
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Children aged 2-59 months with non-severe pneumonia based on WHO criteria of respiratory rate above the age specific cut-off, audible / ausculatory wheeze, accessible to follow up, whose guardians give written informed consent. Exclusion Criteria: * Children with severe dise...

Countries:India
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