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DR-3001a

Phase 2

Urinary Incontinence | Small molecule | Nephrology |Teva Pharmaceutical Industries Limited|Last Updated: Aug 20, 2012

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment800

FDA Designations

No designations recorded

Clinical trial landscape

DR-3001a · 1 trial · 1 indication

Phase 2 1
NCT00196404Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive BladderUrinary Incontinence
COMPLETED800 Analytics
PHASE2COMPLETED
Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder
Urinary IncontinenceUnlock trial analytics

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 to 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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Frequently asked questions about DR-3001a

What is DR-3001a used for?

DR-3001a is an investigational small molecule being developed for the treatment of urinary incontinence, specifically studied in women with overactive bladder. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does DR-3001a target?

The molecular target of DR-3001a has not been disclosed. It is a small molecule being evaluated for its safety and efficacy in treating urinary incontinence, but the specific biological pathway it acts on has not been publicly identified.

Who makes DR-3001a?

DR-3001a is being developed by Teva Pharmaceutical Industries Limited, a company publicly traded under the ticker symbol TEVA. The drug is currently in Phase 2 clinical trials for urinary incontinence.

What phase is DR-3001a in?

DR-3001a is in Phase 2 clinical development. It is an investigational drug and has not received regulatory approval. A Phase 2 trial evaluating its safety and efficacy in women with overactive bladder has been completed.

What clinical trials is DR-3001a in?

DR-3001a has one completed Phase 2 clinical trial, identified as NCT00196404. This randomized, double-blind, placebo-controlled study enrolled 800 women with overactive bladder across the United States and Canada to evaluate the drug's safety and efficacy.

Is DR-3001a the same as DR-3001?

DR-3001a is the drug name provided in the clinical trial data. No alternative names have been disclosed, so it is not known whether DR-3001a is the same as DR-3001 or any other compound.