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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT01939184
First received: September 4, 2013
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia
Drug: WC3055
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome Measures:
  • Change from Baseline in Total IPSS (International Prostate Symptom Score) [ Time Frame: Final Visit (Week 12 or final visit) ] [ Designated as safety issue: No ]
    Sum of Questions 1-7.


Secondary Outcome Measures:
  • Change from Baseline Total IPSS [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Sum of Questions 1-7.

  • Change from Baseline Total IPSS [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Sum of Questions 1-7.

  • Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
    Questions 1, 2, 3, 4, 5, & 15.

  • Change from Baseline IIEF-EF Domain Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
    Questions 1, 2, 3, 4, 5, & 15.

  • Change from Baseline IIEF-EF Domain Score [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    Questions 1, 2, 3, 4, 5, & 15.

  • Change from Baseline IIEF-EF Domain Score [ Time Frame: Final Visit (Week 12 or Final Visit) ] [ Designated as safety issue: No ]
    Questions 1, 2, 3, 4, 5, & 15.


Enrollment: 796
Study Start Date: August 2013
Study Completion Date: April 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01939184

  Show 95 Study Locations
Sponsors and Collaborators
Warner Chilcott
Investigators
Study Director: Herman Ellman, MD Warner Chilcott
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01939184     History of Changes
Other Study ID Numbers: PR-05710
Study First Received: September 4, 2013
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Prostatic Hyperplasia
Hyperplasia
Prostatic Diseases
Genital Diseases, Male
Pathologic Processes

ClinicalTrials.gov processed this record on July 20, 2014