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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00771394
Other study ID # 905-JC-001
Secondary ID
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


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
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