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DR-3001

Phase 3

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment1,104

FDA Designations

No designations recorded

Clinical trial landscape

DR-3001 · 1 trial · 1 indication

Phase 3 1
NCT00685113A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive BladderOveractive Bladder
COMPLETED1,104 Analytics
PHASE3COMPLETED
A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder
Overactive BladderUnlock trial analytics

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)
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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
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Eligibility Criteria

Age Range18 Years to 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
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Frequently asked questions about DR-3001

What is DR-3001 used for?

DR-3001 is an investigational small molecule being developed for the treatment of overactive bladder. It is intended for use in women with this condition. The drug is currently in Phase 3 clinical development and is not yet approved by regulatory authorities.

Who makes DR-3001?

DR-3001 is being developed by Teva Pharmaceutical Industries Limited, a company traded on the stock exchange under the ticker symbol TEVA. The drug is currently in Phase 3 clinical trials for overactive bladder.

What phase is DR-3001 in?

DR-3001 is in Phase 3 clinical development. It is an investigational drug for overactive bladder and has not been approved by regulatory agencies. One Phase 3 trial has been completed, involving 1,104 female participants.

What clinical trials is DR-3001 in?

DR-3001 has one completed Phase 3 clinical trial, identified as NCT00685113. This trial evaluated the efficacy and safety of DR-3001 in women with overactive bladder. The study was randomized, double-blind, and placebo-controlled, enrolling 1,104 participants in the United States and Canada.

Is DR-3001 FDA approved?

DR-3001 is not FDA approved. It is an investigational drug currently in Phase 3 clinical development for overactive bladder. A Phase 3 trial has been completed, but the drug has not yet received regulatory approval.