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

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ClinicalTrials.gov Identifier: NCT01939184
Recruitment Status : Completed
First Posted : September 11, 2013
Last Update Posted : June 29, 2015
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Benign Prostatic Hyperplasia Drug: WC3055 Other: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 796 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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)
Study Start Date : August 2013
Primary Completion Date : March 2014
Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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


Outcome Measures

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


Secondary Outcome Measures :
  1. Change from Baseline Total IPSS [ Time Frame: Week 4 ]
    Sum of Questions 1-7.

  2. Change from Baseline Total IPSS [ Time Frame: Week 8 ]
    Sum of Questions 1-7.

  3. 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.

  4. Change from Baseline IIEF-EF Domain Score [ Time Frame: Week 8 ]
    Questions 1, 2, 3, 4, 5, & 15.

  5. Change from Baseline IIEF-EF Domain Score [ Time Frame: Week 12 ]
    Questions 1, 2, 3, 4, 5, & 15.

  6. Change from Baseline IIEF-EF Domain Score [ Time Frame: Final Visit (Week 12 or Final Visit) ]
    Questions 1, 2, 3, 4, 5, & 15.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01939184


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

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT01939184     History of Changes
Other Study ID Numbers: PR-05710
First Posted: September 11, 2013    Key Record Dates
Last Update Posted: June 29, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Hyperplasia
Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Pathologic Processes
Prostatic Diseases
Genital Diseases, Male
Urological Manifestations
Signs and Symptoms