Recent Updates
Recently added Catalysts

DR-3001

Phase 3

Overactive Bladder | Small molecule | Nephrology |Teva Pharmaceutical Industries Limited|Last Updated: Jul 20, 2016

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment1,104
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00685113A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive BladderPHASE3 COMPLETED 1,104 — — May 1, 2008Mar 1, 2010Jul 20, 201684 United States, Canada
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
Change in total weekly number of incontinence (urge and stress)episodes
Baseline to end-of-treamtent (Week 12/Early withdrawal)
Secondary Endpoints
Change in average daily urinary frequency and average void volume
Baseline to end-of-treamtent (Week 12/Early withdrawal)
Proportion of subjects with no incontinence episodes recorded in the final 3-day diary
Final 3-day diary
3 subject-reported outcome measures: visual analogue scale of OAB symptoms, Urogenital Distress Inventory, Incontinence Impact Question
Baseline to end-of-treatment (Week 12/Early Withdrawal)
Unlock Study Endpoints
Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTAL -
2EXPERIMENTAL -
3PLACEBO_COMPARATOR -
Interventions
NameTypeDescription
DR-3001DRUG4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
PlaceboDRUGPlacebo vaginal ring inserted vaginally and replaced every 4 weeks
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years — N/A
SexFEMALE
Healthy VolunteersYes
Study Sites84

Inclusion Criteria: * Women 18 years of age or older, ambulatory, with a history and presentation consistent with urge incontinence ≥ 6 months * Able to distinguish between stress and urge incontinence * During the Screening Period able to demonstrate the presence of overactive bladder with urge in...

Countries:United StatesCanada
Unlock Eligibility Criteria