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Caldolor

Phase 3

Fever | Small molecule | Other |Cumberland Pharmaceuticals Inc.|Last Updated: Apr 12, 2010

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
RandomizedUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00225706A Study of Caldolor in Hospitalized Febrile Pediatric PatientsPHASE3 COMPLETED -Oct 1, 2005Aug 1, 2007Apr 12, 20103 United States, Panama +1
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Study Endpoints
Primary Endpoints
Temperature
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
CaldolorDRUG -
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Eligibility Criteria
Age Range6 Months — 17 Years
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: 1. Be hospitalized 2. Be between 6 months and 17 years of age, inclusive 3. Have new (not chronic, within last 7 days) onset of fever, documented by temperature greater than or equal to 101.0ºF (38.3ºC) (The preferred method of temperature measurement is core. The route of tempe...

Countries:United StatesPanamaSouth Africa
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