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PD 0299685 at

Phase 2

Interstitial Cystitis | Small molecule | Nephrology |Pfizer, Inc.|Last Updated: Mar 28, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment161
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00739739An Effectiveness And Safety Study Of PD 0299685 For The Treatment Of Symptoms Associated With Interstitial CystitisPHASE2 COMPLETED 161 — — Aug 1, 2008Jan 1, 2010Mar 28, 201144 United States, Canada +4
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Study Endpoints
Primary Endpoints
Change from baseline in the O'Leary-Sant Interstitial Cystitis Symptom Index (ICSI) score.
12 WEEKS
Change from baseline in worst daily pain severity score as measured by an 11-point Numerical Rating Scale (NRS).
12 WEEKS
Secondary Endpoints
Micturition Diary Variables including frequency, urgency, nocturnal frequency, incontinence episodes.
12 weeks
ICSI at other time points
12 weeks
Interstitial Cystitis Problem Index (ICPI)
12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PD 0299685 15mgEXPERIMENTAL -
PD 0299685 30mgEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
PD 0299685 at 15mg BIDDRUG5 mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study
PD 0299685 at 30mg BIDDRUG10mg Capsules, 3 to be taken in the morning and at bedtime for the duration of the study. Initial 2 week titration period at 15mg BID.
placebo for PD 0299685DRUGCapsules identical in appearance to PD 0299685, 3 to be taken in the morning and at bedtime for the duration of the study
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites44

Inclusion Criteria: * Men and women over 18 years of age with moderate to severe interstitial cystitis defined by pain score. * Women must not be pregnant or lactating, They may be post-menopausal, surgically sterilized or using an appropriate method of contraception. Exclusion Criteria: * Histor...

Countries:United StatesCanadaDenmarkFinlandFranceGermany
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