Benign Prostatic HyperplasiaPhase 2NCT01939184

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

A Phase 2 study testing WC3055 in people with Benign Prostatic Hyperplasia, run by Warner Chilcott at 95 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 45 years and older, men only
Conditions the study is for: Benign Prostatic Hyperplasia
What is being tested?: WC3055
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 796 participants
Where: 95 sitesUnited States
Study dates: Aug 2013to Apr 2014
Phase: Phase 2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 45 years and older
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Trial locations and contacts

95 sites in 1 country.

City, postcode or hospital

95 sites in 1 country

United States95 sites

Warner Chilcott Investigational Study Site
Albany, New York, 12208
Warner Chilcott Investigational Study Site
Albuquerque, New Mexico, 87109
Warner Chilcott Investigational Study Site
Anderson, Indiana, 46011
Warner Chilcott Investigational Study Site
Atlanta, Georgia, 30342
Warner Chilcott Investigational Study Site
Austin, Texas, 78756
Warner Chilcott Investigational Study Site
Aventura, Florida, 33180
Warner Chilcott Investigational Study Site
Bala-Cynwyd, Pennsylvania, 19004
Warner Chilcott Investigational Study Site
Bristol, Tennessee, 37620
Warner Chilcott Investigational Study Site
Brookline, Massachusetts, 02445
Warner Chilcott Investigational Study Site
Brooklyn, New York, 11206
Warner Chilcott Investigational Study Site
Cary, North Carolina, 27518
Warner Chilcott Investigational Study Site
Chandler, Arizona, 85224
Warner Chilcott Investigational Study Site
Charleston, South Carolina, 29407
Warner Chilcott Investigational Study Site
Charlotte, North Carolina, 28210
Warner Chilcott Investigational Study Site
Chicago, Illinois, 60654
Warner Chilcott Investigational Study Site
Cincinnati, Ohio, 45212
Warner Chilcott Investigational Study Site
Cincinnati, Ohio, 45215
Warner Chilcott Investigational Study Site
Cincinnati, Ohio, 45249
Warner Chilcott Investigational Study Site
Clearwater, Florida, 33756
Warner Chilcottt Investigational Study Site
Clearwater, Florida, 33761
Warner Chilcott Investigational Study Site
Coeur d'Alene, Idaho, 83864
Warner Chilcott Investigational Study Site
Colorado Springs, Colorado, 80922
Warner Chilcott Investigational Study Site
Columbus, Ohio, 31904
Warner Chilcott Investigational Study Site
Columbus, Ohio, 43212
Warner Chilcott Investigational Study Site
Concord, North Carolina, 28025
Warner Chilcott Investigational Study Site
Dallas, Texas, 75234
Warner Chilcott Investigational Study Site
Denver, Colorado, 80211
Warner Chilcott Investigational Study Site
Denver, Colorado, 80220
Warner Chilcott Investigational Study Site
Denver, Colorado, 80239
Warner Chilcott Investigational Study Site
Elkridge, Maryland, 21075
Warner Chilcott Investigational Study Site
Englewood, Colorado, 80113
Warner Chilcott Investigational Study Site
Evanston, Illinois, 60201
Warner Chilcott Investigational Study Site
Fort Wayne, Indiana, 46825
Warner Chilcott Investigational Study Site
Garden City, New York, 11530
Warner Chilcott Investigational Study Site
Gilbert, Arizona, 85295
Warner Chilcott Investigational Study Site
Glen Burnie, Maryland, 21061
Warner Chilcott Investigational Study Site
Glendale, Arizona, 85306
Warner Chilcott Investigational Study Site
Great Neck, New York, 11021
Warner Chilcott Investigational Study Site
Hialeah, Florida, 33016
Warner Chilcott Investigational Study Site
High Point, North Carolina, 27262
Warner Chilcott Investigational Study Site
Homewood, Alabama, 35209
Warner Chilcott Investigational Study Site
Huntsville, Alabama, 35801
Warner Chilcott Investigational Study Site
Jacksonville, Florida, 32207
Warner Chilcott Investigational Study Site
Jeffersonville, Indiana, 47130
Warner Chilcott Investigational Study Site
Kingston, New York, 12401
Warner Chilcott Investigational Study Site
Kissimmee, Florida, 34741
Warner Chilcott Investigational Study Site
Laguna Hills, California, 92653
Warner Chilcott Investigational Study Site
Lancaster, Pennsylvania, 17604
Warner Chilcott Investigational Study Site
Las Vegas, Nevada, 85282
Warner Chilcott Investigational Study Site
Lawrenceville, New Jersey, 08648
Warner Chilcott Investigational Study Site
Lyndhurst, Ohio, 44124
Warner Chilcott Investigational Study Site
Melrose Park, Illinois, 60160
Warner Chilcott Investigational Study Site
Miami, Florida, 33136
Warner Chilcott Investigational Study Site
Miami, Florida, 33173
Warner Chilcott Investigational Study Site
Middlebury, Connecticut, 06762
Warner Chilcott Investigational Study Site
Mobile, Alabama, 36608
Warner Chilcott Investigational Study Site
Mountlake Terrace, Washington, 98043
Warner Chilcott Investigational Study Site
Muncie, Indiana, 47304
Warner Chilcott Investigational Study Site
Murrieta, California, 92562
Warner Chilcott Investigational Study Site
Myrtle Beach, South Carolina, 29572
Warner Chilcott Investigational Study Site
New Britain, Connecticut, 06052
Warner Chilcott Investigational Study Site
New York, New York, 10016
Warner Chilcott Investigational Study Site
Newburgh, Indiana, 47630
Warner Chilcott Investigational Study Site
Newburgh, New York, 12550
Warner Chilcott Investigational Study Site
Ocala, Florida, 34471
Warner Chilcott Investigational Study Site
Omaha, Nebraska, 68114
Warner Chilcott Investigational Study Site
Overland Park, Kansas, 66202
Warner Chilcott Investigational Study Site
Owing Mills, Maryland, 21117
Warner Chilcott Investigational Study Site
Parker, Colorado, 80134
Warner Chilcott Investigational Study Site
Pembroke Pines, Florida, 33028
Warner Chilcott Investigational Study Site
Phoenix, Arizona, 85032
Warner Chilcott Investigational Study Site
Poughkeepsie, New York, 12601
Warner Chilcott Investigational Study Site
Raleigh, North Carolina, 27609
Warner Chilcott Investigational Study Site
Raleigh, North Carolina, 27612
Warner Chilcott Investigational Study Site
Reading, Pennsylvania, 19609
Warner Chilcott Investigational Study Site
Salisbury, North Carolina, 28144
Warner Chilcott Investigational Study Site
Salt Lake City, Utah, 84107
Warner Chilcott Investigational Study Site
San Antonio, Texas, 78229
Warner Chilcott Investigational Study Site
San Diego, California, 92103
Warner Chilcott Investigational Study Site
San Diego, California, 92108
Warner Chilcott Investigational Study Site
San Diego, California, 92120
Warner Chilcott Investigational Study Site
San Diego, California, 92123
Warner Chilcott Investigational Study Site
Sandy Springs, Georgia, 30328
Warner Chilcott Investigational Study Site
Shreveport, Louisiana, 71106
Warner Chilcott Investigational Study Site
Springfield, Illinois, 62703
Warner Chilcott Investigational Study Site
Springfield, Illinois, 62794
Warner Chilcott Investigational Study Site
Tallahassee, Florida, 32308
Warner Chilcott Investigational Study Site
Towson, Maryland, 21204
Warner Chilcott Investigational Study Site
Virginia Beach, Virginia, 23462
Warner Chilcott Investigational Study Site
Warwick, Rhode Island, 02886
Warner Chilcott Investigational Study Site
Wauwatosa, Wisconsin, 53226
Warner Chilcott Investigational Study Site
West Des Moines, Iowa, 50266
Warner Chilcott Investigational Study Site
Wilmington, North Carolina, 28401
Warner Chilcott Investigational Study Site
Winchester, Virginia, 22601
Warner Chilcott Investigational Study Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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)

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
Being tested: WC3055, Placebo
Medical subject headings: Prostatic Hyperplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WC3055Drug
12.5, 25, 50 or 75 mg dose
PlaceboOther
Placebo

Study groups in NCT01939184
Study group	Role	What they receive
WC3055-01F	Experimental	WC3055 12.5 mg tablet once daily for 12 weeks Receives: Drug: WC3055
WC3055-02F	Experimental	WC3055 25 mg tablet once daily for 12 weeks Receives: Drug: WC3055
WC3055-03F	Experimental	WC3055 50 mg tablet once daily for 12 weeks Receives: Drug: WC3055
WC3055-04F	Experimental	WC3055 75 mg tablet once daily for 12 weeks Receives: Drug: WC3055
WC3055-07P	Placebo comparator	Placebo tablet once daily for 12 weeks Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change from Baseline in Total IPSS (International Prostate Symptom Score)
Sum of Questions 1-7.
Measured: Final Visit (Week 12 or final visit)

Secondary outcomes (6)

Change from Baseline Total IPSS
Sum of Questions 1-7.
Measured: Week 4
Change from Baseline Total IPSS
Sum of Questions 1-7.
Measured: Week 8
Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score
Questions 1, 2, 3, 4, 5, \& 15.
Measured: Week 4
Change from Baseline IIEF-EF Domain Score
Questions 1, 2, 3, 4, 5, \& 15.
Measured: Week 8
Change from Baseline IIEF-EF Domain Score
Questions 1, 2, 3, 4, 5, \& 15.
Measured: Week 12
Change from Baseline IIEF-EF Domain Score
Questions 1, 2, 3, 4, 5, \& 15.
Measured: Final Visit (Week 12 or Final Visit)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Apr 2014

First posted11 Sep 2013 (estimated)
Study startAug 2013
Primary completionMar 2014
Study completionApr 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 796 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01939184
Sponsor's protocol ID: PR-05710
Status last verified: Jun 2015
First submitted: 4 Sep 2013
Last updated: 29 Jun 2015
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

All Benign Prostatic Hyperplasia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT01939184
Acronym / sponsor ID: PR-05710
Conditions: Benign Prostatic Hyperplasia
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 796 participants (actual)
Lead sponsor: Warner ChilcottIndustry (pharma, biotech, devices)
Study start: Aug 2013
Primary completion: Mar 2014 (actual)
Study completion: Apr 2014 (actual)
First posted: 11 Sep 2013 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
WC3055-01F	Experimental	Drug: WC3055WC3055 12.5 mg tablet once daily for 12 weeks
WC3055-02F	Experimental	Drug: WC3055WC3055 25 mg tablet once daily for 12 weeks
WC3055-03F	Experimental	Drug: WC3055WC3055 50 mg tablet once daily for 12 weeks
WC3055-04F	Experimental	Drug: WC3055WC3055 75 mg tablet once daily for 12 weeks
WC3055-07P	Placebo comparator	Other: PlaceboPlacebo tablet once daily for 12 weeks

Who may qualify

Ages: 45 years and older
Sex: Male only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WC305512.5, 25, 50 or 75 mg dose	Drug	WC3055-01F, WC3055-02F, WC3055-03F, WC3055-04F
PlaceboPlacebo	Other	WC3055-07P

Primary outcome

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

6 secondary outcomes

Change from Baseline Total IPSS
Time frame: Week 4
Change from Baseline Total IPSS
Time frame: Week 8
Change from Baseline IIEF-EF (International Index of Erectile Function-Erectile Function) Domain Score
Time frame: Week 4
Change from Baseline IIEF-EF Domain Score
Time frame: Week 8
Change from Baseline IIEF-EF Domain Score
Time frame: Week 12
Change from Baseline IIEF-EF Domain Score
Time frame: Final Visit (Week 12 or Final Visit)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2015.

Related trials for Benign Prostatic Hyperplasia

Recruiting
Clinical Study on Prostate Thermal Vapor Ablation Guided by MRI/TRUS Fusion Imaging
Benign Prostatic Hyperplasia (BPH)
Active, not recruitingPhase 4
Standard Versus Double Alpha Blockers Treatment for Symptomatic Benign Prostatic Obstruction
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
Recruiting
Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
RecruitingObservational study
Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
Prostatic Hyperplasia, Benign

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Herman Ellman, MD study director

Warner Chilcott

95 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing WC3055 in people with Benign Prostatic Hyperplasia, run by Warner Chilcott at 95 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 95 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline in Total IPSS (International Prostate Symptom Score) (time frame: Final Visit (Week 12 or final visit)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01939184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2015.