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DR-3001a

Phase 2

Urinary Incontinence | Small molecule | Nephrology |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 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_CONTROLLED
Total Trials1
Total Enrollment800
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00196404Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive BladderPHASE2 COMPLETED 800Oct 1, 2004Dec 1, 2006Aug 20, 201248 United States, Canada
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Study Endpoints
Primary Endpoints
Change in the total weekly number of incontinence episodes
Baseline to Treatment Week 12/Premature Discontinuation
Secondary Endpoints
Average daily urinary frequency
Baseline to Treatment Week 12/Premature Discontinuation
Proportion of patients with no incontinence episodes
Baseline to Treatment Week 12/Premature Discontinuation
Average void volume
Baseline to Treatment Week 12/Premature Discontinuation
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
DR-3001aDRUG4mg daily vaginally
DR-3001bDRUG6 mg vaginally daily
PlaceboOTHERAdministered vaginally to match experimental arms
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Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersNo
Study Sites48

Inclusion Criteria: * Diagnosis of overactive bladder and incontinence for at least 6 months * Using birth control or menopausal * Willing to discontinue current medication for overactive bladder Exclusion Criteria: * Pregnant or given birth in the last 6 months * Three or more urinary tract infe...

Countries:United StatesCanada
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