Clinical trial NCT00685113: A Clinical Trial to Evaluate the Efficacy and Safety of DR-3001 in Women With Overactive Bladder
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 1104
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in total weekly number of incontinence (urge and stress)episodes
timeFrame: Baseline to end-of-treamtent (Week 12/Early withdrawal)
Secondary outcomes:
measure: Change in average daily urinary frequency and average void volume
timeFrame: Baseline to end-of-treamtent (Week 12/Early withdrawal)
measure: Proportion of subjects with no incontinence episodes recorded in the final 3-day diary
timeFrame: Final 3-day diary
measure: 3 subject-reported outcome measures: visual analogue scale of OAB symptoms, Urogenital Distress Inventory, Incontinence Impact Question
timeFrame: Baseline to end-of-treatment (Week 12/Early Withdrawal)
measure: Adverse events (AEs) reported by subjects or identified by the investigator
timeFrame: Basline to end-of-treatment (Week 12/Early Withdrawal)
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Mobile
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Montgomery
country: United States
facility: Duramed Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Duramed Investigational Site
state: Arizona
city: Little Rock
country: United States
facility: Duramed Investigational Site
state: Arkansas
city: Encinitas
country: United States
facility: Duramed Investigational Site
state: California
city: Los Angeles
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: San Diego
country: United States
facility: Duramed Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Denver
country: United States
facility: Duramed Investigational Site
state: Colorado
city: Danbury
country: United States
facility: Duramed Investigational Site
state: Connecticut
city: Milford
country: United States
facility: Duramed Investigational Site
state: Connecticut
city: New London
country: United States
facility: Duramed Investigational Site
state: Connecticut
city: Aventura
country: United States
facility: Duramed Investigational Site
state: Florida
city: Gainesville
country: United States
facility: Duramed Investigational Site
state: Florida
city: Jacksonville
country: United States
facility: Duramed Investigational Site
state: Florida
city: Miami
country: United States
facility: Duramed Investigational Site
state: Florida
city: New Port Richey
country: United States
facility: Duramed Investigational Site
state: Florida
city: Tampa
country: United States
facility: Duramed Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Duramed Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Duramed Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Augusta
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Decatur
country: United States
facility: Duramed Investigation Site
state: Georgia
city: Savannah
country: United States
facility: Duramed Investigational Site
state: Georgia
city: Boise
country: United States
facility: Duramed Investigational Site
state: Idaho
city: Boise
country: United States
facility: Duramed Investigational Site
state: Idaho
city: Coeur d'Alene
country: United States
facility: Duramed Investigational Site
state: Idaho
city: Meridian
country: United States
facility: Duramed Investigational Site
state: Idaho
city: Fort Wayne
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Jeffersonville
country: United States
facility: Duramed Investigational Site
state: Indiana
city: South Bend
country: United States
facility: Duramed Investigational Site
state: Indiana
city: Newton
country: United States
facility: Duramed Investigational Site
state: Kansas
city: Wichita
country: United States
facility: Duramed Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Duramed Investigational Site
state: Kentucky
city: Lafayette
country: United States
facility: Duramed Investigational Site
state: Louisiana
city: Marrero
country: United States
facility: Duramed Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Duramed Investigational Site
state: Louisiana
city: Watertown
country: United States
facility: Duramed Investigational Site
state: Massachusetts
city: Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: N. Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Lebanon
country: United States
facility: Duramed Investigational Site
state: New Hampshire
city: Lawrenceville
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Moorestown
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: New Brunswick
country: United States
facility: Duramed Investigational Site
state: New Jersey
city: Albuquerque
country: United States
facility: Duramed Investigational Site
state: New Mexico
city: Port Jefferson
country: United States
facility: Duramed Investigational Site
state: New York
city: New Bern
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Duramed Investigational Site
state: North Carolina
city: Cleveland
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Mayfield Heights
country: United States
facility: Duramed Investigational Site
state: Ohio
city: Bethany
country: United States
facility: Duramed Investigational Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Duramed Investigational Site
state: Oklahoma
city: Eugene
country: United States
facility: Duramed Investigational Site
state: Oregon
city: Medford
country: United States
facility: Duramed Investigational Site
state: Oregon
city: Philadelphia
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Pottstown
country: United States
facility: Duramed Investigational Site
state: Pennsylvania
city: Charlestown
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Columbia
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Greensville
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Hilton Head Island
country: United States
facility: Duramed Investigational Site
state: South Carolina
city: Jackson
country: United States
facility: Duramed Investigational Site
state: Tennessee
city: Dallas
country: United States
facility: Duramed Investigational Site
state: Texas
city: Dallas
country: United States
facility: Duramed Investigational Site
state: Texas
city: Dallas
country: United States
facility: Duramed Investigational Site
state: Texas
city: Houston
country: United States
facility: Duramed Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Duramed Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Duramed Investigational Site
state: Texas
city: Waco
country: United States
facility: Duramed Investigational Site
state: Texas
city: Salt Lake City
country: United States
facility: Duramed Investigational Site
state: Utah
city: Williston
country: United States
facility: Duramed Investigational Site
state: Vermont
city: Norfolk
country: United States
facility: Duramed Investigational Site
state: Virginia
city: Seattle
country: United States
facility: Duramed Investigational Site
state: Washington
city: Tacoma
country: United States
facility: Duramed Investigational Site
state: Washington
city: Vancouver
country: Canada
facility: Duramed Investigatinal Site
state: British Columbia
city: Oshawa
country: Canada
facility: Duramed Investigational Site
state: Ontario
city: Thunder Bay
country: Canada
facility: Duramed Investigational Site
state: Ontario
Study officials:
affiliation: Duramed Research, Inc.
name: Duramed Research Protocol Chair
role: STUDY_CHAIR
References: