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effervescent ibuprofen

Phase 3

Pain | Small molecule | Pain |Pfizer, Inc.|Last Updated: Aug 10, 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment270
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00631111Study Evaluating the Efficacy of an Ibuprofen Effervescent Tablet in the Treatment of Post-Surgical Dental PainPHASE3 COMPLETED 270Nov 1, 2007Apr 1, 2008Aug 10, 20091 United States
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Study Endpoints
Primary Endpoints
Sum of pain relief and pain intensity difference scores
8 hours
Secondary Endpoints
Time to meaningful pain relief
8 hours
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2ACTIVE_COMPARATOR -
3ACTIVE_COMPARATOR -
4PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
effervescent ibuprofen tabletsDRUG -
effervescent Aspirin plus Vitamin C tabletsDRUG -
ibuprofen tabletsDRUG -
placeboDRUG -
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Eligibility Criteria
Age Range16 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion: * Moderate or severe post-operative pain following surgical extraction of two or more third molars, at least one of which must be a partial or complete bony mandibular impaction * In general good health with no contraindications to the study medication or rescue medication (tramadol or a...

Countries:United States
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