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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

796

Phase

  • 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

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
Intervention / Treatment
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

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

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

Warner Chilcott

Investigators

  • 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

August 1, 2013

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 11, 2013

Study Record Updates

Last Update Posted (Estimate)

June 29, 2015

Last Update Submitted That Met QC Criteria

June 1, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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