Assess Safety & Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia

June 1, 2015 updated by: Warner Chilcott

A Study to Assess the Safety and Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)

The purpose of this study is to evaluate the safety and efficacy of various fixed daily doses of WC3055 compared with placebo for the treatment of subjects with LUTS secondary to BPH.

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.
796

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 2

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

  • United States
    • Alabama
      • Homewood, Alabama, United States, 35209
        • Warner Chilcott Investigational Study Site
      • Huntsville, Alabama, United States, 35801
        • Warner Chilcott Investigational Study Site
      • Mobile, Alabama, United States, 36608
        • Warner Chilcott Investigational Study Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Warner Chilcott Investigational Study Site
      • Gilbert, Arizona, United States, 85295
        • Warner Chilcott Investigational Study Site
      • Glendale, Arizona, United States, 85306
        • Warner Chilcott Investigational Study Site
      • Phoenix, Arizona, United States, 85032
        • Warner Chilcott Investigational Study Site
    • California
      • Laguna Hills, California, United States, 92653
        • Warner Chilcott Investigational Study Site
      • Murrieta, California, United States, 92562
        • Warner Chilcott Investigational Study Site
      • San Diego, California, United States, 92103
        • Warner Chilcott Investigational Study Site
      • San Diego, California, United States, 92108
        • Warner Chilcott Investigational Study Site
      • San Diego, California, United States, 92123
        • Warner Chilcott Investigational Study Site
      • San Diego, California, United States, 92120
        • Warner Chilcott Investigational Study Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80922
        • Warner Chilcott Investigational Study Site
      • Denver, Colorado, United States, 80211
        • Warner Chilcott Investigational Study Site
      • Denver, Colorado, United States, 80220
        • Warner Chilcott Investigational Study Site
      • Denver, Colorado, United States, 80239
        • Warner Chilcott Investigational Study Site
      • Englewood, Colorado, United States, 80113
        • Warner Chilcott Investigational Study Site
      • Parker, Colorado, United States, 80134
        • Warner Chilcott Investigational Study Site
    • Connecticut
      • Middlebury, Connecticut, United States, 06762
        • Warner Chilcott Investigational Study Site
      • New Britain, Connecticut, United States, 06052
        • Warner Chilcott Investigational Study Site
    • Florida
      • Aventura, Florida, United States, 33180
        • Warner Chilcott Investigational Study Site
      • Clearwater, Florida, United States, 33756
        • Warner Chilcott Investigational Study Site
      • Clearwater, Florida, United States, 33761
        • Warner Chilcottt Investigational Study Site
      • Hialeah, Florida, United States, 33016
        • Warner Chilcott Investigational Study Site
      • Jacksonville, Florida, United States, 32207
        • Warner Chilcott Investigational Study Site
      • Kissimmee, Florida, United States, 34741
        • Warner Chilcott Investigational Study Site
      • Miami, Florida, United States, 33136
        • Warner Chilcott Investigational Study Site
      • Miami, Florida, United States, 33173
        • Warner Chilcott Investigational Study Site
      • Ocala, Florida, United States, 34471
        • Warner Chilcott Investigational Study Site
      • Pembroke Pines, Florida, United States, 33028
        • Warner Chilcott Investigational Study Site
      • Tallahassee, Florida, United States, 32308
        • Warner Chilcott Investigational Study Site
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Warner Chilcott Investigational Study Site
      • Sandy Springs, Georgia, United States, 30328
        • Warner Chilcott Investigational Study Site
    • Idaho
      • Coeur d'Alene, Idaho, United States, 83864
        • Warner Chilcott Investigational Study Site
    • Illinois
      • Chicago, Illinois, United States, 60654
        • Warner Chilcott Investigational Study Site
      • Evanston, Illinois, United States, 60201
        • Warner Chilcott Investigational Study Site
      • Melrose Park, Illinois, United States, 60160
        • Warner Chilcott Investigational Study Site
      • Springfield, Illinois, United States, 62703
        • Warner Chilcott Investigational Study Site
      • Springfield, Illinois, United States, 62794
        • Warner Chilcott Investigational Study Site
    • Indiana
      • Anderson, Indiana, United States, 46011
        • Warner Chilcott Investigational Study Site
      • Fort Wayne, Indiana, United States, 46825
        • Warner Chilcott Investigational Study Site
      • Jeffersonville, Indiana, United States, 47130
        • Warner Chilcott Investigational Study Site
      • Muncie, Indiana, United States, 47304
        • Warner Chilcott Investigational Study Site
      • Newburgh, Indiana, United States, 47630
        • Warner Chilcott Investigational Study Site
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Warner Chilcott Investigational Study Site
    • Kansas
      • Overland Park, Kansas, United States, 66202
        • Warner Chilcott Investigational Study Site
    • Louisiana
      • Shreveport, Louisiana, United States, 71106
        • Warner Chilcott Investigational Study Site
    • Maryland
      • Elkridge, Maryland, United States, 21075
        • Warner Chilcott Investigational Study Site
      • Glen Burnie, Maryland, United States, 21061
        • Warner Chilcott Investigational Study Site
      • Owing Mills, Maryland, United States, 21117
        • Warner Chilcott Investigational Study Site
      • Towson, Maryland, United States, 21204
        • Warner Chilcott Investigational Study Site
    • Massachusetts
      • Brookline, Massachusetts, United States, 02445
        • Warner Chilcott Investigational Study Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Warner Chilcott Investigational Study Site
    • Nevada
      • Las Vegas, Nevada, United States, 85282
        • Warner Chilcott Investigational Study Site
    • New Jersey
      • Lawrenceville, New Jersey, United States, 08648
        • Warner Chilcott Investigational Study Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Warner Chilcott Investigational Study Site
    • New York
      • Albany, New York, United States, 12208
        • Warner Chilcott Investigational Study Site
      • Brooklyn, New York, United States, 11206
        • Warner Chilcott Investigational Study Site
      • Garden City, New York, United States, 11530
        • Warner Chilcott Investigational Study Site
      • Great Neck, New York, United States, 11021
        • Warner Chilcott Investigational Study Site
      • Kingston, New York, United States, 12401
        • Warner Chilcott Investigational Study Site
      • New York, New York, United States, 10016
        • Warner Chilcott Investigational Study Site
      • Newburgh, New York, United States, 12550
        • Warner Chilcott Investigational Study Site
      • Poughkeepsie, New York, United States, 12601
        • Warner Chilcott Investigational Study Site
    • North Carolina
      • Cary, North Carolina, United States, 27518
        • Warner Chilcott Investigational Study Site
      • Charlotte, North Carolina, United States, 28210
        • Warner Chilcott Investigational Study Site
      • Concord, North Carolina, United States, 28025
        • Warner Chilcott Investigational Study Site
      • High Point, North Carolina, United States, 27262
        • Warner Chilcott Investigational Study Site
      • Raleigh, North Carolina, United States, 27609
        • Warner Chilcott Investigational Study Site
      • Raleigh, North Carolina, United States, 27612
        • Warner Chilcott Investigational Study Site
      • Salisbury, North Carolina, United States, 28144
        • Warner Chilcott Investigational Study Site
      • Wilmington, North Carolina, United States, 28401
        • Warner Chilcott Investigational Study Site
      • Winston-Salem, North Carolina, United States, 27103
        • Warner Chilcott Investigational Study Site
    • Ohio
      • Cincinnati, Ohio, United States, 45249
        • Warner Chilcott Investigational Study Site
      • Cincinnati, Ohio, United States, 45212
        • Warner Chilcott Investigational Study Site
      • Cincinnati, Ohio, United States, 45215
        • Warner Chilcott Investigational Study Site
      • Columbus, Ohio, United States, 31904
        • Warner Chilcott Investigational Study Site
      • Columbus, Ohio, United States, 43212
        • Warner Chilcott Investigational Study Site
      • Lyndhurst, Ohio, United States, 44124
        • Warner Chilcott Investigational Study Site
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
        • Warner Chilcott Investigational Study Site
      • Lancaster, Pennsylvania, United States, 17604
        • Warner Chilcott Investigational Study Site
      • Reading, Pennsylvania, United States, 19609
        • Warner Chilcott Investigational Study Site
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • Warner Chilcott Investigational Study Site
    • South Carolina
      • Charleston, South Carolina, United States, 29407
        • Warner Chilcott Investigational Study Site
      • Myrtle Beach, South Carolina, United States, 29572
        • Warner Chilcott Investigational Study Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Warner Chilcott Investigational Study Site
    • Texas
      • Austin, Texas, United States, 78756
        • Warner Chilcott Investigational Study Site
      • Dallas, Texas, United States, 75234
        • Warner Chilcott Investigational Study Site
      • San Antonio, Texas, United States, 78229
        • Warner Chilcott Investigational Study Site
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Warner Chilcott Investigational Study Site
    • Virginia
      • Virginia Beach, Virginia, United States, 23462
        • Warner Chilcott Investigational Study Site
      • Winchester, Virginia, United States, 22601
        • Warner Chilcott Investigational Study Site
    • Washington
      • Mountlake Terrace, Washington, United States, 98043
        • Warner Chilcott Investigational Study Site
    • Wisconsin
      • Wauwatosa, Wisconsin, United States, 53226
        • Warner Chilcott Investigational Study 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

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • History of LUTS for ≥6 months secondary to BPH
  • Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening

Exclusion Criteria:

-

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 Assignment
  • 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: WC3055-01F
WC3055 12.5 mg tablet once daily for 12 weeks
Drug: WC3055
12.5, 25, 50 or 75 mg dose
Experimental: WC3055-02F
WC3055 25 mg tablet once daily for 12 weeks
Drug: WC3055
12.5, 25, 50 or 75 mg dose
Experimental: WC3055-03F
WC3055 50 mg tablet once daily for 12 weeks
Drug: WC3055
12.5, 25, 50 or 75 mg dose
Experimental: WC3055-04F
WC3055 75 mg tablet once daily for 12 weeks
Drug: WC3055
12.5, 25, 50 or 75 mg dose
Placebo Comparator: WC3055-07P
Placebo tablet once daily for 12 weeks
Other: Placebo
Placebo

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
Measure Description
Time Frame
Change from Baseline in Total IPSS (International Prostate Symptom Score)
Time Frame: Final Visit (Week 12 or final visit)
Sum of Questions 1-7.
Final Visit (Week 12 or final visit)

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
Measure Description
Time Frame
Change from Baseline Total IPSS
Time Frame: Week 4
Sum of Questions 1-7.
Week 4
Change from Baseline Total IPSS
Time Frame: Week 8
Sum of Questions 1-7.
Week 8
Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score
Time Frame: Week 4
Questions 1, 2, 3, 4, 5, & 15.
Week 4
Change from Baseline IIEF-EF Domain Score
Time Frame: Week 8
Questions 1, 2, 3, 4, 5, & 15.
Week 8
Change from Baseline IIEF-EF Domain Score
Time Frame: Week 12
Questions 1, 2, 3, 4, 5, & 15.
Week 12
Change from Baseline IIEF-EF Domain Score
Time Frame: Final Visit (Week 12 or Final Visit)
Questions 1, 2, 3, 4, 5, & 15.
Final Visit (Week 12 or Final Visit)

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.
Warner Chilcott

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Herman Ellman, MD, Warner Chilcott

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.
August 1, 2013

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, 2014

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.
April 1, 2014

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).
September 4, 2013

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.
September 4, 2013

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.
September 11, 2013

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.
June 29, 2015

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.
June 1, 2015

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.
June 1, 2015

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.
  • PR-05710

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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