A Study to Evaluate Add on Effect of Solifenacin in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks

This study is currently recruiting participants.

Verified by Astellas Pharma Inc, October 2009

First Received: March 25, 2009 Last Updated: October 26, 2009 History of Changes

Sponsor:	Astellas Pharma Inc
Collaborators:	Astellas Pharma Korea, Inc. Sungkyunkwan University School of Medicine
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00884104

Purpose

The purpose of this study is to evaluate the rate of "add-on" solifenacin treatment and its persistency in men with over active bladder symptoms after tamsulosin monotherapy for 4 weeks.

Condition	Intervention	Phase
Overactive Bladder	Drug: Solifenacin	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Prospective, Open-label, Observational, Multi-center Study for the Identification of Predictive Factors for the Solifenacin Treatment in Men With Overactive Bladder Symptoms After Tamsulosin Monotherapy for 4 Weeks and Evaluation of Efficacy and Persistency of Add on Solifenacin in Men With Residual Overactive Bladder Symptoms After Previous Monotherapy With Tamsulosin.

Resource links provided by NLM:

Drug Information available for: Tamsulosin Tamsulosin hydrochloride Solifenacin Solifenacin succinate

U.S. FDA Resources

Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:

Percentage of patients with "add-on" solifenacin treatment [ Time Frame: Weeks of 12, 24 and 52 of combination therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change from baseline in micturition efficacy parameters [ Time Frame: Weeks of 12, 24 and 52 of combination therapy ] [ Designated as safety issue: No ]

Estimated Enrollment:	900
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1.tamsulosin + solifenacin: Experimental	Drug: Solifenacin Oral

Detailed Description:

This is a multi-center study to evaluate the efficacy, safety, and persistency of solifenacin treatment in male patients with persistent OAB symptoms of urinary frequency and urgency with/without urgency incontinence who are receiving tamsulosin monotherapy for LUTS at a stable dose for 4 weeks in real life practice. Also proportion of patients and predictive factors with persistent OAB symptoms after tamsulosin monotherapy will be investigated.

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

IPSS ≥ 12
Symptoms of OAB as verified by the V8 (≥8)
Symptoms of OAB as verified by the screening 3-day bladder diary, defined by:
- Mean urinary frequency ≥8 times/24 hours
- Mean number of micturition-related urgency episodes ≥3 episode/24 hours (with a Urinary Sensation Scale rating of ≥3 marked for the corresponding micturition in the bladder diary)

Exclusion Criteria:

Treatment within the 14 days preceding treatment with any alpha blocker drugs
A known history of bladder outlet obstruction due to: bladder neck contracture, clinical suspicion of prostate carcinoma, mullerian duct cysts, urethral obstruction due to stricture/valves/sclerosis or urethral tumor

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884104

Contacts

Contact: Clinical Development Administration Department

clinicaltrials_info@jp.astellas.com

Locations

Korea, Republic of
	Recruiting
Seoul, Korea, Republic of
	Recruiting
Suwon, Korea, Republic of
	Recruiting
Pusan, Korea, Republic of
	Recruiting
Daegu, Korea, Republic of
	Recruiting
Daejeon, Korea, Republic of
	Recruiting
Cheon-ju, Korea, Republic of
	Recruiting
Kangneung, Korea, Republic of
	Recruiting
Choongju, Korea, Republic of
	Recruiting
Kwang-ju, Korea, Republic of

Sponsors and Collaborators

Astellas Pharma Inc

Astellas Pharma Korea, Inc.

Sungkyunkwan University School of Medicine

Investigators

Principal Investigator:

Kyu-Sung Lee, MD

University School of Medicine, Kangnan-ku, Seoul, Korea

More Information

No publications provided

Responsible Party:	Astellas Pharma, Inc ( Disclosure Director )
Study ID Numbers:	SMK-3
Study First Received:	March 25, 2009
Last Updated:	October 26, 2009
ClinicalTrials.gov Identifier:	NCT00884104 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Solifenacin
Tamsulosin
OAB

Additional relevant MeSH terms:

Urinary Bladder, Overactive
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Antineoplastic Agents
Physiological Effects of Drugs
Urinary Bladder Diseases
Adrenergic alpha-Antagonists
Cholinergic Agents

Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Therapeutic Uses
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Tamsulosin
Adrenergic Antagonists

ClinicalTrials.gov processed this record on February 08, 2010