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

NCT01939184 | Completed Phase 2

• 1 other identifier: PR-05710
• Study Type: interventional
• Target: 796
• Locations: 1 country
• Sites: 95

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.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Total IPSS (International Prostate Symptom Score)

  Sum of Questions 1-7.

  Final Visit (Week 12 or final visit)

Secondary Outcomes (6)

• Change from Baseline Total IPSS

  Week 4

• Change from Baseline Total IPSS

  Week 8

• Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score

  Week 4

• Change from Baseline IIEF-EF Domain Score

  Week 8

• Change from Baseline IIEF-EF Domain Score

  Week 12

Study Arms (5)

WC3055-01F

EXPERIMENTAL

WC3055 12.5 mg tablet once daily for 12 weeks

Drug: WC3055

WC3055-02F

EXPERIMENTAL

WC3055 25 mg tablet once daily for 12 weeks

Drug: WC3055

WC3055-03F

EXPERIMENTAL

WC3055 50 mg tablet once daily for 12 weeks

Drug: WC3055

WC3055-04F

EXPERIMENTAL

WC3055 75 mg tablet once daily for 12 weeks

Drug: WC3055

WC3055-07P

PLACEBO COMPARATOR

Placebo tablet once daily for 12 weeks

Other: Placebo

Interventions

WC3055 DRUG

12.5, 25, 50 or 75 mg dose

WC3055-01F; WC3055-02F; WC3055-03F; WC3055-04F

Placebo OTHER

Placebo

WC3055-07P

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Warner Chilcott: lead

Study Sites (95)

Warner Chilcott Investigational Study Site

Homewood, Alabama, 35209, United States

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Huntsville, Alabama, 35801, United States

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Mobile, Alabama, 36608, United States

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Chandler, Arizona, 85224, United States

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Gilbert, Arizona, 85295, United States

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Glendale, Arizona, 85306, United States

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Phoenix, Arizona, 85032, United States

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Laguna Hills, California, 92653, United States

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Murrieta, California, 92562, United States

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San Diego, California, 92103, United States

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San Diego, California, 92108, United States

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San Diego, California, 92120, United States

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San Diego, California, 92123, United States

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Colorado Springs, Colorado, 80922, United States

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Denver, Colorado, 80211, United States

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Denver, Colorado, 80220, United States

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Denver, Colorado, 80239, United States

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Englewood, Colorado, 80113, United States

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Parker, Colorado, 80134, United States

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Middlebury, Connecticut, 06762, United States

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New Britain, Connecticut, 06052, United States

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Aventura, Florida, 33180, United States

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Clearwater, Florida, 33756, United States

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Clearwater, Florida, 33761, United States

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Hialeah, Florida, 33016, United States

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Jacksonville, Florida, 32207, United States

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Kissimmee, Florida, 34741, United States

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Miami, Florida, 33136, United States

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Miami, Florida, 33173, United States

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Ocala, Florida, 34471, United States

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Pembroke Pines, Florida, 33028, United States

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Tallahassee, Florida, 32308, United States

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Atlanta, Georgia, 30342, United States

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Sandy Springs, Georgia, 30328, United States

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Coeur d'Alene, Idaho, 83864, United States

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Chicago, Illinois, 60654, United States

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Evanston, Illinois, 60201, United States

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Melrose Park, Illinois, 60160, United States

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Springfield, Illinois, 62703, United States

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Springfield, Illinois, 62794, United States

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Anderson, Indiana, 46011, United States

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Fort Wayne, Indiana, 46825, United States

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Jeffersonville, Indiana, 47130, United States

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Muncie, Indiana, 47304, United States

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Newburgh, Indiana, 47630, United States

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West Des Moines, Iowa, 50266, United States

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Overland Park, Kansas, 66202, United States

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Shreveport, Louisiana, 71106, United States

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Elkridge, Maryland, 21075, United States

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Glen Burnie, Maryland, 21061, United States

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Owing Mills, Maryland, 21117, United States

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Towson, Maryland, 21204, United States

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Brookline, Massachusetts, 02445, United States

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Omaha, Nebraska, 68114, United States

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Las Vegas, Nevada, 85282, United States

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Lawrenceville, New Jersey, 08648, United States

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Albuquerque, New Mexico, 87109, United States

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Albany, New York, 12208, United States

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Brooklyn, New York, 11206, United States

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Garden City, New York, 11530, United States

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Great Neck, New York, 11021, United States

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Kingston, New York, 12401, United States

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New York, New York, 10016, United States

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Newburgh, New York, 12550, United States

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Poughkeepsie, New York, 12601, United States

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Cary, North Carolina, 27518, United States

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Charlotte, North Carolina, 28210, United States

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Concord, North Carolina, 28025, United States

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High Point, North Carolina, 27262, United States

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Raleigh, North Carolina, 27609, United States

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Raleigh, North Carolina, 27612, United States

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Salisbury, North Carolina, 28144, United States

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Wilmington, North Carolina, 28401, United States

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Winston-Salem, North Carolina, 27103, United States

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Cincinnati, Ohio, 45212, United States

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Cincinnati, Ohio, 45215, United States

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Cincinnati, Ohio, 45249, United States

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Columbus, Ohio, 31904, United States

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Columbus, Ohio, 43212, United States

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Lyndhurst, Ohio, 44124, United States

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Bala-Cynwyd, Pennsylvania, 19004, United States

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Lancaster, Pennsylvania, 17604, United States

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Reading, Pennsylvania, 19609, United States

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Warwick, Rhode Island, 02886, United States

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Charleston, South Carolina, 29407, United States

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Myrtle Beach, South Carolina, 29572, United States

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Bristol, Tennessee, 37620, United States

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Austin, Texas, 78756, United States

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Dallas, Texas, 75234, United States

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San Antonio, Texas, 78229, United States

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Salt Lake City, Utah, 84107, United States

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Virginia Beach, Virginia, 23462, United States

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Winchester, Virginia, 22601, United States

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Mountlake Terrace, Washington, 98043, United States

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Wauwatosa, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Herman Ellman, MD

  Warner Chilcott

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: September 4, 2013
• First Posted: September 11, 2013
• Study Start: August 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: April 1, 2014
• Last Updated: June 29, 2015

Record last verified: 2015-06

Locations

US (95)