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

July 18, 2016 updated by: Duramed Research

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1104

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2B5
        • Duramed Investigatinal Site
    • Ontario
      • Oshawa, Ontario, Canada, L1H 7K4
        • Duramed Investigational Site
      • Thunder Bay, Ontario, Canada, P7E 6E7
        • Duramed Investigational Site
  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Duramed Investigational Site
      • Mobile, Alabama, United States, 36608
        • Duramed Investigational Site
      • Montgomery, Alabama, United States, 36116
        • Duramed Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85015
        • Duramed Investigational Site
      • Tucson, Arizona, United States, 85741
        • Duramed Investigational Site
      • Tucson, Arizona, United States, 85712
        • Duramed Investigational Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Duramed Investigational Site
    • California
      • Encinitas, California, United States, 92024
        • Duramed Investigational Site
      • Los Angeles, California, United States, 90036
        • Duramed Investigational Site
      • San Diego, California, United States, 92108
        • Duramed Investigational Site
      • San Diego, California, United States, 92103
        • Duramed Investigational Site
      • San Diego, California, United States, 92123
        • Duramed Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Duramed Investigational Site
      • Denver, Colorado, United States, 80220
        • Duramed Investigational Site
    • Connecticut
      • Danbury, Connecticut, United States, 06810
        • Duramed Investigational Site
      • Milford, Connecticut, United States, 06460
        • Duramed Investigational Site
      • New London, Connecticut, United States, 06320
        • Duramed Investigational Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Duramed Investigational Site
      • Gainesville, Florida, United States, 32607
        • Duramed Investigational Site
      • Jacksonville, Florida, United States, 32207
        • Duramed Investigational Site
      • Miami, Florida, United States, 33143
        • Duramed Investigational Site
      • New Port Richey, Florida, United States, 34655
        • Duramed Investigational Site
      • Tampa, Florida, United States, 33607
        • Duramed Investigational Site
      • West Palm Beach, Florida, United States, 33407
        • Duramed Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Duramed Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Duramed Investigational Site
      • Augusta, Georgia, United States, 30901
        • Duramed Investigational Site
      • Decatur, Georgia, United States, 30034
        • Duramed Investigation Site
      • Savannah, Georgia, United States, 31406
        • Duramed Investigational Site
    • Idaho
      • Boise, Idaho, United States, 83712
        • Duramed Investigational Site
      • Boise, Idaho, United States, 83704
        • Duramed Investigational Site
      • Coeur d'Alene, Idaho, United States, 83814
        • Duramed Investigational Site
      • Meridian, Idaho, United States, 83642
        • Duramed Investigational Site
    • Indiana
      • Fort Wayne, Indiana, United States, 46825
        • Duramed Investigational Site
      • Jeffersonville, Indiana, United States, 47130
        • Duramed Investigational Site
      • South Bend, Indiana, United States, 46601
        • Duramed Investigational Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Duramed Investigational Site
      • Wichita, Kansas, United States, 67207
        • Duramed Investigational Site
    • Kentucky
      • Louisville, Kentucky, United States, 40291
        • Duramed Investigational Site
    • Louisiana
      • Lafayette, Louisiana, United States, 70503
        • Duramed Investigational Site
      • Marrero, Louisiana, United States, 70072
        • Duramed Investigational Site
      • Shreveport, Louisiana, United States, 71106
        • Duramed Investigational Site
    • Massachusetts
      • Watertown, Massachusetts, United States, 02472
        • Duramed Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Duramed Investigational Site
      • Las Vegas, Nevada, United States, 89128
        • Duramed Investigational Site
      • N. Las Vegas, Nevada, United States, 89030
        • Duramed Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Duramed Investigational Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Duramed Investigational Site
      • Moorestown, New Jersey, United States, 08057
        • Duramed Investigational Site
      • New Brunswick, New Jersey, United States, 08901
        • Duramed Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Duramed Investigational Site
    • New York
      • Port Jefferson, New York, United States, 11777
        • Duramed Investigational Site
    • North Carolina
      • New Bern, North Carolina, United States, 28562
        • Duramed Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Duramed Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Duramed Investigational Site
      • Mayfield Heights, Ohio, United States, 44124
        • Duramed Investigational Site
    • Oklahoma
      • Bethany, Oklahoma, United States, 73008
        • Duramed Investigational Site
      • Oklahoma City, Oklahoma, United States, 73112
        • Duramed Investigational Site
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Duramed Investigational Site
      • Medford, Oregon, United States, 97504
        • Duramed Investigational Site
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19114
        • Duramed Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Duramed Investigational Site
      • Pittsburgh, Pennsylvania, United States, 15206
        • Duramed Investigational Site
      • Pottstown, Pennsylvania, United States, 19464
        • Duramed Investigational Site
    • South Carolina
      • Charlestown, South Carolina, United States, 29425
        • Duramed Investigational Site
      • Columbia, South Carolina, United States, 29201
        • Duramed Investigational Site
      • Greensville, South Carolina, United States, 29605
        • Duramed Investigational Site
      • Hilton Head Island, South Carolina, United States, 29926
        • Duramed Investigational Site
    • Tennessee
      • Jackson, Tennessee, United States, 38305
        • Duramed Investigational Site
    • Texas
      • Dallas, Texas, United States, 75390
        • Duramed Investigational Site
      • Dallas, Texas, United States, 75234
        • Duramed Investigational Site
      • Dallas, Texas, United States, 78229
        • Duramed Investigational Site
      • Houston, Texas, United States, 77024
        • Duramed Investigational Site
      • San Antonio, Texas, United States, 78229
        • Duramed Investigational Site
      • San Antonio, Texas, United States, 78209
        • Duramed Investigational Site
      • Waco, Texas, United States, 76712
        • Duramed Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Duramed Investigational Site
    • Vermont
      • Williston, Vermont, United States, 05495
        • Duramed Investigational Site
    • Virginia
      • Norfolk, Virginia, United States, 23507
        • Duramed Investigational Site
    • Washington
      • Seattle, Washington, United States, 98105
        • Duramed Investigational Site
      • Tacoma, Washington, United States, 98405
        • Duramed Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 1
Drug: DR-3001
4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
Other Names:
  • Oxybutinyn Vaginal Ring
Drug: DR-3001
6mg/day vaginal ring inserted vaginally and replaced every 4 weeks
Other Names:
  • Oxybutinyn Vaginal Ring
EXPERIMENTAL: 2
Drug: DR-3001
4mg/day vaginal ring inserted vaginally and replaced every 4 weeks
Other Names:
  • Oxybutinyn Vaginal Ring
Drug: DR-3001
6mg/day vaginal ring inserted vaginally and replaced every 4 weeks
Other Names:
  • Oxybutinyn Vaginal Ring
PLACEBO_COMPARATOR: 3
Drug: Placebo
Placebo vaginal ring inserted vaginally and replaced every 4 weeks

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change in total weekly number of incontinence (urge and stress)episodes
Time Frame: Baseline to end-of-treamtent (Week 12/Early withdrawal)
Baseline to end-of-treamtent (Week 12/Early withdrawal)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Change in average daily urinary frequency and average void volume
Time Frame: Baseline to end-of-treamtent (Week 12/Early withdrawal)
Baseline to end-of-treamtent (Week 12/Early withdrawal)
Proportion of subjects with no incontinence episodes recorded in the final 3-day diary
Time Frame: Final 3-day diary
Final 3-day diary
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)
Baseline to end-of-treatment (Week 12/Early Withdrawal)
Adverse events (AEs) reported by subjects or identified by the investigator
Time Frame: Basline to end-of-treatment (Week 12/Early Withdrawal)
Basline to end-of-treatment (Week 12/Early Withdrawal)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duramed Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 28, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 18, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • DR-OXY-301

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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