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Completed

NCT Number: NCT00196404

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

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

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Key information

Conditions

Urinary Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Duramed Investigational Site, Vancouver, British Columbia, Canada

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DR-3001a

Drug

4mg daily vaginally

DR-3001b

Drug

6 mg vaginally daily

Placebo

Other

Administered vaginally to match experimental arms

Primary outcomes

  1. Change in the total weekly number of incontinence episodes

    Time frame: Baseline to Treatment Week 12/Premature Discontinuation

Secondary outcomes

  1. Average daily urinary frequency

    Time frame: Baseline to Treatment Week 12/Premature Discontinuation

  2. Proportion of patients with no incontinence episodes

    Time frame: Baseline to Treatment Week 12/Premature Discontinuation

  3. Average void volume

    Time frame: Baseline to Treatment Week 12/Premature Discontinuation

  4. Average severity of urgency

    Time frame: Baseline to Treatment Week 12/Premature Discontinuation

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Aug 20, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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