Solifenacin as Add-on Therapy for Overactive Bladder Symptoms in Men Treated for Benign Prostatic Hyperplasia
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Benign Prostatic Hyperplasia; Benign Prostatic Hypertrophy; Overactive Bladder
Intervention: Tamsulosin hydrochloride (Drug); Solifenacin succinate (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s): Central Contact, Study Chair, Affiliation: Astellas Pharma Inc
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from baseline in mean number of urgency episodes per 24 hours
Secondary outcome: Mean number of micturitions per 24 hrsMean number of incontinence episodes per 24 hours Mean number of micturitions per night Adverse Events, Laboratory Tests
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
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Male.
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
Locations and Contacts
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Shikoku, Japan
Touhoku, Japan
Additional Information
Link to results on JAPIC - enter JapicCTI-R120267 in the JapicCTI-RNo. field
Starting date: October 2008
Last updated: February 13, 2013
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