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

Primary Purpose

Benign Prostatic Hyperplasia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
WC3055
Placebo
Sponsored by
Warner Chilcott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

-

Sites / Locations

  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
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  • Warner Chilcott Investigational Study Site
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  • Warner Chilcott Investigational Study Site
  • Warner Chilcottt Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
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  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
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  • Warner Chilcott Investigational Study Site
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  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site
  • Warner Chilcott Investigational Study Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

WC3055-01F

WC3055-02F

WC3055-03F

WC3055-04F

WC3055-07P

Arm Description

WC3055 12.5 mg tablet once daily for 12 weeks

WC3055 25 mg tablet once daily for 12 weeks

WC3055 50 mg tablet once daily for 12 weeks

WC3055 75 mg tablet once daily for 12 weeks

Placebo tablet once daily for 12 weeks

Outcomes

Primary Outcome Measures

Change from Baseline in Total IPSS (International Prostate Symptom Score)
Sum of Questions 1-7.

Secondary Outcome Measures

Change from Baseline Total IPSS
Sum of Questions 1-7.
Change from Baseline Total IPSS
Sum of Questions 1-7.
Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score
Questions 1, 2, 3, 4, 5, & 15.
Change from Baseline IIEF-EF Domain Score
Questions 1, 2, 3, 4, 5, & 15.
Change from Baseline IIEF-EF Domain Score
Questions 1, 2, 3, 4, 5, & 15.
Change from Baseline IIEF-EF Domain Score
Questions 1, 2, 3, 4, 5, & 15.

Full Information

First Posted
September 4, 2013
Last Updated
June 1, 2015
Sponsor
Warner Chilcott
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1. Study Identification

Unique Protocol Identification Number
NCT01939184
Brief Title
Assess Safety & Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia
Official Title
A Study to Assess the Safety and Efficacy of WC3055 in Men With Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostatic Hyperplasia (BPH)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Warner Chilcott

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
796 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WC3055-01F
Arm Type
Experimental
Arm Description
WC3055 12.5 mg tablet once daily for 12 weeks
Arm Title
WC3055-02F
Arm Type
Experimental
Arm Description
WC3055 25 mg tablet once daily for 12 weeks
Arm Title
WC3055-03F
Arm Type
Experimental
Arm Description
WC3055 50 mg tablet once daily for 12 weeks
Arm Title
WC3055-04F
Arm Type
Experimental
Arm Description
WC3055 75 mg tablet once daily for 12 weeks
Arm Title
WC3055-07P
Arm Type
Placebo Comparator
Arm Description
Placebo tablet once daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
WC3055
Intervention Description
12.5, 25, 50 or 75 mg dose
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from Baseline in Total IPSS (International Prostate Symptom Score)
Description
Sum of Questions 1-7.
Time Frame
Final Visit (Week 12 or final visit)
Secondary Outcome Measure Information:
Title
Change from Baseline Total IPSS
Description
Sum of Questions 1-7.
Time Frame
Week 4
Title
Change from Baseline Total IPSS
Description
Sum of Questions 1-7.
Time Frame
Week 8
Title
Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score
Description
Questions 1, 2, 3, 4, 5, & 15.
Time Frame
Week 4
Title
Change from Baseline IIEF-EF Domain Score
Description
Questions 1, 2, 3, 4, 5, & 15.
Time Frame
Week 8
Title
Change from Baseline IIEF-EF Domain Score
Description
Questions 1, 2, 3, 4, 5, & 15.
Time Frame
Week 12
Title
Change from Baseline IIEF-EF Domain Score
Description
Questions 1, 2, 3, 4, 5, & 15.
Time Frame
Final Visit (Week 12 or Final Visit)

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of LUTS for ≥6 months secondary to BPH Total IPSS (International Prostate Symptom Score) ≥ 13 at Screening Exclusion Criteria: -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Herman Ellman, MD
Organizational Affiliation
Warner Chilcott
Official's Role
Study Director
Facility Information:
Facility Name
Warner Chilcott Investigational Study Site
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Gilbert
State/Province
Arizona
ZIP/Postal Code
85295
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Murrieta
State/Province
California
ZIP/Postal Code
92562
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80922
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80211
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80239
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Parker
State/Province
Colorado
ZIP/Postal Code
80134
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Middlebury
State/Province
Connecticut
ZIP/Postal Code
06762
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
New Britain
State/Province
Connecticut
ZIP/Postal Code
06052
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Warner Chilcottt Investigational Study Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33028
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Coeur d'Alene
State/Province
Idaho
ZIP/Postal Code
83864
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Melrose Park
State/Province
Illinois
ZIP/Postal Code
60160
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62703
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46825
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Jeffersonville
State/Province
Indiana
ZIP/Postal Code
47130
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47304
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Elkridge
State/Province
Maryland
ZIP/Postal Code
21075
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Glen Burnie
State/Province
Maryland
ZIP/Postal Code
21061
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Owing Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02445
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
85282
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Lawrenceville
State/Province
New Jersey
ZIP/Postal Code
08648
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11206
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Garden City
State/Province
New York
ZIP/Postal Code
11530
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Newburgh
State/Province
New York
ZIP/Postal Code
12550
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27518
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45215
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
31904
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Lyndhurst
State/Province
Ohio
ZIP/Postal Code
44124
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19609
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Myrtle Beach
State/Province
South Carolina
ZIP/Postal Code
29572
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23462
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Winchester
State/Province
Virginia
ZIP/Postal Code
22601
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Mountlake Terrace
State/Province
Washington
ZIP/Postal Code
98043
Country
United States
Facility Name
Warner Chilcott Investigational Study Site
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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