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Completed

NCT Number: NCT00685113

A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder

This is a multicenter study to evaluate the efficacy and safety of 2 different doses of DR-3001. For eligible subjects the duration of the study will be approximately 20 weeks; this will consist of a 4-week screening period, a 12-week treatment period and a 4-week follow-up period. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit. Subjects will be required to insert a vaginal ring (replacing it every 4 weeks) and to keep a daily record of their toilet voids (including time,type and volume) for 3 days at several specified time points.

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Key information

Conditions

Overactive Bladder 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 Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Duramed Investigatinal Site, Vancouver, British Columbia, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

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 incontinence based on diary entries
  • Others as dictated by FDA-approved protocol

Exclusion criteria

  • Stress incontinence, continuous incontinence or overflow urinary incontinence
  • Chronic illness, neurological dysfunction or injury that could cause incontinence
  • Pregnant, breastfeeding, or gave birth in the last 6 months
  • Others as dictated by FDA-approved protocol

Treatment and study plan

DR-3001

Drug

4mg/day vaginal ring inserted vaginally and replaced every 4 weeks

Other names: Oxybutinyn Vaginal Ring

Placebo

Drug

Placebo vaginal ring inserted vaginally and replaced every 4 weeks

Primary outcomes

  1. Change in total weekly number of incontinence (urge and stress)episodes

    Time frame: Baseline to end-of-treamtent (Week 12/Early withdrawal)

Secondary outcomes

  1. Change in average daily urinary frequency and average void volume

    Time frame: Baseline to end-of-treamtent (Week 12/Early withdrawal)

  2. Proportion of subjects with no incontinence episodes recorded in the final 3-day diary

    Time frame: Final 3-day diary

  3. 3 subject-reported outcome measures: visual analogue scale of OAB symptoms, Urogenital Distress Inventory, Incontinence Impact Question

    Time frame: Baseline to end-of-treatment (Week 12/Early Withdrawal)

  4. Adverse events (AEs) reported by subjects or identified by the investigator

    Time frame: Basline to end-of-treatment (Week 12/Early Withdrawal)

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of Two Doses of DR-3001 Versus Placebo in Women With Overactive Bladder

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
May 28, 2008
Registry last updated
Jul 20, 2016

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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