Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

A Multicenter, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00196404

Enrollment

800

Registered

2005-09-20

Start date

2004-10-31

Completion date

2006-12-31

Last updated

2012-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

Keywords

overactive bladder, urge incontinence, urinary incontinence

Brief summary

This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency

Detailed description

This is a multi-center, randomized, placebo-controlled study to compare two doses of DR-3001 to placebo for a 12-week treatment period. The overall duration of patient participation will be for approximately 19 weeks. Patients will be required to keep a daily diary record of study medication use and incontinence episodes

Interventions

DRUGDR-3001a

4mg daily vaginally

DRUGDR-3001b

6 mg vaginally daily

OTHERPlacebo

Administered vaginally to match experimental arms

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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 infections a year * Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis * History of bladder cancer, ulcerative colitis or severe constipation * Any contraindication to vaginal delivery systems

Design outcomes

Primary

Measure	Time frame
Change in the total weekly number of incontinence episodes	Baseline to Treatment Week 12/Premature Discontinuation

Secondary

Measure	Time frame
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
Average severity of urgency	Baseline to Treatment Week 12/Premature Discontinuation

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026