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

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00771394

Purpose

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

Condition	Intervention	Phase
Benign Prostatic Hyperplasia Benign Prostatic Hypertrophy Overactive Bladder	Drug: Tamsulosin hydrochloride Drug: Solifenacin succinate	Phase IV

Drug Information available for: Succinic acid Solifenacin succinate Solifenacin Tamsulosin Tamsulosin hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Change from baseline in mean number of urgency episodes per 24 hours [ Time Frame: at 4, 8, 12 week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean number of micturitions per 24 hrs [ Time Frame: at 4, 8, 12 week ] [ Designated as safety issue: No ]
Mean number of incontinence episodes per 24 hours [ Time Frame: at 4, 8, 12 week ] [ Designated as safety issue: No ]
Mean number of micturitions per night [ Time Frame: at 4, 8, 12 week ] [ Designated as safety issue: No ]
Adverse Events, Laboratory Tests [ Time Frame: end of study ] [ Designated as safety issue: No ]

Estimated Enrollment:	660
Study Start Date:	October 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Tamsulosin alone	Drug: Tamsulosin hydrochloride oral
2: Experimental Tamsulosin + solifenacin (low dose)	Drug: Tamsulosin hydrochloride oral Drug: Solifenacin succinate oral
3: Active Comparator Tamsulosin + solifenacin (high dose)	Drug: Tamsulosin hydrochloride oral Drug: Solifenacin succinate oral

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

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00771394

Contacts

Contact: Clinical Development Adminstration Department

clinicaltrials_info@jp.astellas.com

Locations

Japan
	Recruiting
Hokkaido, Japan
	Recruiting
Touhoku, Japan
	Recruiting
Kantou, Japan
	Recruiting
Chubu, Japan
	Recruiting
Kyushu, Japan
	Recruiting
Shikoku, Japan
	Recruiting
Chugoku, Japan
	Recruiting
Kansai, Japan

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

Responsible Party:	Astellas Pharma Inc. ( Director )
Study ID Numbers:	905-JC-001
Study First Received:	October 9, 2008
Last Updated:	October 23, 2008
ClinicalTrials.gov Identifier:	NCT00771394
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:

Vesicare
Solifenacin succinate
Tamsulosin
Overactive Bladder
BPH

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Urinary Bladder, Overactive
Cystocele
Prostatic Diseases
Urinary Bladder Diseases
Genital Diseases, Male
Signs and Symptoms

Hyperplasia
Hypertrophy
Prostatic Hyperplasia
Urologic Diseases
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Tamsulosin

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Antineoplastic Agents
Physiological Effects of Drugs
Adrenergic alpha-Antagonists

Cholinergic Agents
Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Pathologic Processes
Therapeutic Uses
Adrenergic Antagonists

ClinicalTrials.gov processed this record on January 16, 2009