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Oxybutynin chloride

Phase 2

Menopause | Small molecule | Other |Johnson & Johnson|Last Updated: Dec 12, 2012

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 Enrollment148
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00990886The Effect of Extended-Release Oxybutynin Chloride on Vasomotor Symptoms in Healthy Post-Menopausal WomenPHASE2 COMPLETED 148 — — Apr 1, 2004Jan 1, 2005Dec 12, 2012 - —
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Study Endpoints
Primary Endpoints
The co-primary endpoints in this study are the change in daily frequency of moderate to severe hot flashes from baseline to Week 12 and the change in severity of moderate to severe hot flashes from baseline to Week 12.
Week 12 in the study corresponds to visit 6 that is scheduled from day 78 to day 84.
Secondary Endpoints
Change in daily frequency of moderate to severe hot flashes from baseline to Week 4 and 12
Weeks 4 and 12
Change in severity of moderate to severe hot flashes from baseline to Week 4 and 12
Weeks 4 and 12
Change of daily composite score of moderate to severe hot flashes from baseline to Week 4 and Week 12
Weeks 4 and 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
001EXPERIMENTALOxybutynin chloride 15 mg once daily for 12 weeks
002PLACEBO_COMPARATORPlacebo Once daily for 12 weeks
Interventions
NameTypeDescription
PlaceboDRUGOnce daily for 12 weeks
Oxybutynin chlorideDRUG15 mg once daily for 12 weeks
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Eligibility Criteria
Age Range40 Years — 65 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Patients must be in good health * Must be naturally postmenopausal and have not experienced menses for at least 6 months prior to the start of the study * Must have serum FSH levels \> 40 mIU/mL * Must average seven or more moderate to severe hot flushes with sweating per day,...

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