Back to results

Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia

Primary Purpose

Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Overactive Bladder

Status

Completed

Phase

Phase 4

Locations

Japan

Study Type

Interventional

Intervention

Tamsulosin hydrochloride

Solifenacin succinate

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia focused on measuring Vesicare, Solifenacin succinate, Tamsulosin, Overactive Bladder, BPH

Eligibility Criteria

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

Inclusion Criteria:

Patients with benign prostatic hypertrophy who have been treated with tamsulosin for at least 6 weeks
Patients with urgency episodes and frequent micturitions
Written informed consent has been obtained
Uroflowmetry-Q max ≥ 5 mL/sec, and Post Void Residual Volume < 50 mL

Exclusion Criteria:

Patients with suspected symptoms of OAB whose onset is only transient (drug-induced, psychogenic, etc.)
Patients with obvious stress urinary incontinence
Patients with complications or who have a past history of a bladder tumor
Patients with urethral stricture or bladder neck stenosis
Patients with a history of surgery causing damage to the pelvic plexus
Patients with history of hypersensitivity to α receptor blockers, a/b receptor blockers, or anticholinergic drugs
Patients with orthostatic hypotension, ulcerative colitis, hyperthyroidism, dementia or cognitive dysfunction, Parkinson's disease, or cerebrovascular disorder

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Active Comparator

Arm Label

1. Tamsulosin alone

2. Tamsulosin + solifenacin (low dose)

3. Tamsulosin + solifenacin (high dose)

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in mean number of urgency episodes per 24 hours

Secondary Outcome Measures

Mean number of micturitions per 24 hrs

Mean number of incontinence episodes per 24 hours

Mean number of micturitions per night

Adverse Events, Laboratory Tests

Full Information

NCT ID

NCT00771394

First Posted

October 9, 2008

Last Updated

February 13, 2013

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00771394

Brief Title

Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study of Solifenacin Succinate as Add-on Therapy for Overactive Bladder (OAB) Symptoms in Men Treated for Benign Prostatic Hyperplasia (BPH) With Tamsulosin Hydrochloride

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

January 2010 (Actual)

Study Completion Date

January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

To evaluate the efficacy and safety of solifenacin succinate as add-on therapy for overactive bladder (OAB) symptoms in men who have been treated for benign prostatic hyperplasia (BPH) with tamsulosin hydrochloride for at least 6 weeks

Detailed Description

Study drugs are administered for 14 weeks in total, including a 2-week run-in period (single blind) and a 12-week treatment period (double blind). After written informed consent, study drugs for the run-in period are orally administered once daily after breakfast for two weeks to subjects who fulfill the inclusion and exclusion criteria. Then, subjects are randomized and orally treated with study drugs for the treatment period once daily after breakfast for 12 weeks

6. Conditions and Keywords

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

Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy, Overactive Bladder

Keywords

Vesicare, Solifenacin succinate, Tamsulosin, Overactive Bladder, BPH

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

638 (Actual)

8. Arms, Groups, and Interventions

Arm Title

1. Tamsulosin alone

Arm Type

Placebo Comparator

Arm Title

2. Tamsulosin + solifenacin (low dose)

Arm Type

Experimental

Arm Title

3. Tamsulosin + solifenacin (high dose)

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Tamsulosin hydrochloride

Other Intervention Name(s)

Harnal, YM617

Intervention Description

oral

Intervention Type

Drug

Intervention Name(s)

Solifenacin succinate

Other Intervention Name(s)

Vesicare, YM905

Intervention Description

oral

Primary Outcome Measure Information:

Title

Change from baseline in mean number of urgency episodes per 24 hours

Time Frame

at 4, 8, 12 week

Secondary Outcome Measure Information:

Title

Mean number of micturitions per 24 hrs

Time Frame

at 4, 8, 12 week

Title

Mean number of incontinence episodes per 24 hours

Time Frame

at 4, 8, 12 week

Title

Mean number of micturitions per night

Time Frame

at 4, 8, 12 week

Title

Adverse Events, Laboratory Tests

Time Frame

end of study

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients with benign prostatic hypertrophy who have been treated with tamsulosin for at least 6 weeks Patients with urgency episodes and frequent micturitions Written informed consent has been obtained Uroflowmetry-Q max ≥ 5 mL/sec, and Post Void Residual Volume < 50 mL Exclusion Criteria: Patients with suspected symptoms of OAB whose onset is only transient (drug-induced, psychogenic, etc.) Patients with obvious stress urinary incontinence Patients with complications or who have a past history of a bladder tumor Patients with urethral stricture or bladder neck stenosis Patients with a history of surgery causing damage to the pelvic plexus Patients with history of hypersensitivity to α receptor blockers, a/b receptor blockers, or anticholinergic drugs Patients with orthostatic hypotension, ulcerative colitis, hyperthyroidism, dementia or cognitive dysfunction, Parkinson's disease, or cerebrovascular disorder

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Central Contact

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Study Chair

Facility Information:

City

Chubu

Country

Japan

City

Chugoku

Country

Japan

City

Hokkaido

Country

Japan

City

Kansai

Country

Japan

City

Kantou

Country

Japan

City

Kyushu

Country

Japan

City

Shikoku

Country

Japan

City

Touhoku

Country

Japan

12. IPD Sharing Statement

Links:

URL

http://www.clinicaltrials.jp/user/ctrSearch_e.jsp

Description

Link to results on JAPIC - enter JapicCTI-R120267 in the JapicCTI-RNo. field

Learn more about this trial

Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia

We'll reach out to this number within 24 hrs