Brief Summary

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

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

800

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Oct 2004

Geographic Reach

2 countries

48 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.2 years study duration

Study Start

First participant enrolled

October 1, 2004

Completed

12 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed

7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed

Last Updated

August 20, 2012

Status Verified

August 1, 2012

Enrollment Period

2.2 years

First QC Date

September 13, 2005

Last Update Submit

August 17, 2012

Conditions

Urinary Incontinence

Keywords

overactive bladderurge incontinenceurinary incontinence

Outcome Measures

Primary Outcomes (1)

Change in the total weekly number of incontinence episodes
Baseline to Treatment Week 12/Premature Discontinuation

Secondary Outcomes (4)

Average daily urinary frequency
Baseline to Treatment Week 12/Premature Discontinuation
Proportion of patients with no incontinence episodes
Baseline to Treatment Week 12/Premature Discontinuation
Average void volume
Baseline to Treatment Week 12/Premature Discontinuation
Average severity of urgency
Baseline to Treatment Week 12/Premature Discontinuation

Study Arms (3)

1

EXPERIMENTAL

Drug: DR-3001a

2

EXPERIMENTAL

Drug: DR-3001b

3

PLACEBO COMPARATOR

Other: Placebo

Interventions

DR-3001aDRUG

4mg daily vaginally

DR-3001bDRUG

6 mg vaginally daily

PlaceboOTHER

Administered vaginally to match experimental arms

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Diagnosis of overactive bladder and incontinence for at least 6 months
Using birth control or menopausal
Willing to discontinue current medication for overactive bladder

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Duramed Researchlead

Study Sites (48)

Duramed Investigational Site

Birmingham, Alabama, 35209, United States

Location

Duramed Investigational Site

Huntsville, Alabama, 35801, United States

Location

Duramed Investigational Site

Mobile, Alabama, 36608, United States

Location

Duramed Research Site

Phoenix, Arizona, 85015, United States

Location

Duramed Research Site

Tucson, Arizona, 85712, United States

Location

Duramed Investigational Site

Little Rock, Arkansas, 72205, United States

Location

Duramed Investigational Site

San Diego, California, 92108, United States

Location

Duremed Research Site

San Diego, California, 92108, United States

Location

Duramed Investigational Site

Aurora, Colorado, 80012, United States

Location

Duramed Research Site

Colorado Springs, Colorado, 80909, United States

Location

Duramed Investigational Site

Denver, Colorado, 80220, United States

Location

Duramed Investigational Site

Waterbury, Connecticut, 06708, United States

Location

Duramed Investigational Site

Aventura, Florida, 33180, United States

Location

Duramed Research Site

Gainesville, Florida, 32607, United States

Location

Duramed Investigational Site

Decatur, Georgia, 30034, United States

Location

Duramed Research Site

Sandy Springs, Georgia, 30328, United States

Location

Duramed Investigational Site

Boise, Idaho, 83712, United States

Location

Duramed Investigational Site

Boise, Indiana, 83705, United States

Location

Duramed Investigational Site

Evansville, Indiana, 47714, United States

Location

Duramed Investigational Site

Fort Wayne, Indiana, 46825, United States

Location

Duramed Investigational Site

Indianapolis, Indiana, 46202, United States

Location

Duramed Investigational Site

Jeffersonville, Indiana, 47130, United States

Location

Duramed Investigational Site

Meridian, Indiana, 83642, United States

Location

Duramed Investigational Site

Shreveport, Louisiana, 71106, United States

Location

Duramed Investigational Site

Jackson, Mississippi, 39202, United States

Location

Duramed Investigational Site

Lebanon, New Hampshire, 03756, United States

Location

Duramed Investigational Site

Edison, New Jersey, 08837, United States

Location

Duramed Investigational Site

Livingston, New Jersey, 07039, United States

Location

Duramed Investigational Site

Moorestown, New Jersey, 08057, United States

Location

Duramed Investigational Site

Williamsville, New York, 14221, United States

Location

Duramed Investigational Site

Portland, Oregon, 97210, United States

Location

Duramed Investigational Site

Lancaster, Pennsylvania, 17604, United States

Location

Duramed Investigational Site

Philadelphia, Pennsylvania, 19114, United States

Location

Duramed Investigational Site

Providence, Rhode Island, 02904, United States

Location

Duramed Investigational Site

Charleston, South Carolina, 29425, United States

Location

Duramed Investigational Site

Jackson, Tennessee, 38305, United States

Location

Duramed Investigational Site

Memphis, Tennessee, 38120, United States

Location

Duramed Investigational Site

Nashville, Tennessee, 37232, United States

Location

Duramed Investigational Site

Dallas, Texas, 75234, United States

Location

Duramed Research Site

Houston, Texas, 77024, United States

Location

Duramed Investigational Site

San Antonio, Texas, 78229, United States

Location

Duramed Research Site

Waco, Texas, 76712, United States

Location

Duramed Investigational Site

Salt Lake City, Utah, 84124, United States

Location

Duramed Investigational Site

Seattle, Washington, 98105, United States

Location

Duramed Research Site

Tacoma, Washington, 98405, United States

Location

Duramed Investigational Site

Milwaukee, Wisconsin, 53209, United States

Location

Duramed Investigational Site

Vancouver, British Columbia, V6T2B5, Canada

Location

Duramed Investigational Site

Toronto, Ontario, M4N3M5, Canada

Location

Related Publications (1)

Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PMID: 37160401DERIVED

MeSH Terms

Conditions

Urinary IncontinenceUrinary Bladder, OveractiveUrinary Incontinence, Urge

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary Bladder Diseases

Study Officials

Medical Monitor
Duramed Research
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: PARTICIPANT, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

October 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

August 20, 2012

Record last verified: 2012-08

Locations

US(46)CA(2)

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

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (48)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (3)

1

2

3

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (48)

Related Publications (1)

Related Links

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations