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
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 |
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
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma Inc |
Japan,
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 |
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