Clinical trial NCT00782769: A Safety Extension Study of DR-OXY-301
Official title: A Multicenter, Parallel-Group Extension Study to Evaluate the Safety of Two Doses of DR-3001 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: 2008-10-31
Enrollment: 240
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a safety extension study of DR-OXY-301 at pre-selected sites. Subjects who complete the DR-OXY-301 study are eligible to participate. The duration of this extension study will be up to approximately 42 weeks. Subjects will have physical and laboratory exams, including blood draws at each scheduled visit and colposcopic examination of the vagina and cervix. As in DR-OXY-301, subjects will be required to insert a vaginal ring; replacing it every 4 weeks. Subjects will also be required to keep a daily record of the number of times and the total amount of time the ring was outside the body each day and the reason for voluntary removal.


Eligibility criteria: Inclusion Criteria:

* Completed the 12 weeks of treatment in the DR-OXY-301 study
* Willing to limit medications for overactive bladder to investigational product only
* Able to understand and complete all study procedures including the required diary

Primary outcomes:
measure: Safety, by investigating post void residual volume, physical exams, vital signs, and clinical laboratory values. The outcome of any pregnancy will be followed and reported
timeFrame: Duration of Study
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Duramed Investigational Site
state: Arizona
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: Miami
country: United States
facility: Duramed Investigational Site
state: Florida
city: Tampa
country: United States
facility: Duramed Investigational Site
state: Florida
city: Augusta
country: United States
facility: Duramed Investigational 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: Chicago
country: United States
facility: Duramed Investigational Site
state: Illinois
city: Wichita
country: United States
facility: Duramed Investigational Site
state: Kansas
city: Louisville
country: United States
facility: Duramed Investigational Site
state: Kentucky
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: Las Vegas
country: United States
facility: Duramed Investigational Site
state: Nevada
city: Moorestown
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: 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: Columbia
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: Houston
country: United States
facility: Duramed Investigational Site
state: Texas
city: Waco
country: United States
facility: Duramed Investigational Site
state: Texas
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
Study officials:
affiliation: Duramed Research, Inc
name: Duramed Research Protocol Chair
role: STUDY_CHAIR
References: