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

Overactive Bladder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00771394
• Other study ID #: 905-JC-001
• Status: Completed
• Phase: Phase 4
• First received: October 9, 2008
• Last updated: February 13, 2013
• Start date: October 2008
• Est. completion date: January 2010

Study information

• Verified date: February 2013
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 638
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 50 Years and older

Eligibility

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 a 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

Study Design

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

Related Conditions & MeSH terms

• Benign Prostatic Hyperplasia
• Benign Prostatic Hypertrophy
• Hyperplasia
• Hypertrophy
• Overactive Bladder
• Prostatic Hyperplasia
• Urinary Bladder, Overactive

Intervention

Drug:
• Tamsulosin hydrochloride
oral
• Solifenacin succinate
oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in mean number of urgency episodes per 24 hours		at 4, 8, 12 week	No
Secondary	Mean number of micturitions per 24 hrs		at 4, 8, 12 week	No
Secondary	Mean number of incontinence episodes per 24 hours		at 4, 8, 12 week	No
Secondary	Mean number of micturitions per night		at 4, 8, 12 week	No
Secondary	Adverse Events, Laboratory Tests		end of study	No

External Links

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