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

Duramed Research

Status and phase: Completed; Phase 2

Conditions: Urinary Incontinence

Treatments: Drug: DR-3001b; Other: Placebo; Drug: DR-3001a

Study type: Interventional

Funder types: Industry

Identifiers

NCT00196404

BR-OXY-202

Details and patient eligibility

About

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

Full 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

Enrollment: 800 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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800 participants in 3 patient groups, including a placebo group

1

Experimental group

Treatment:

Drug: DR-3001a

2

Experimental group

Treatment:

Drug: DR-3001b

3

Placebo Comparator group

Treatment:

Other: Placebo