A Study Comparing Tamsulosin Versus the Combination Tamsulosin Plus Solifenacin in Men With Overactive Bladder

This study is currently recruiting participants.

Verified by Astellas Pharma Inc, February 2009

First Received: June 16, 2008 Last Updated: February 23, 2009 History of Changes

Sponsored by:	Astellas Pharma Inc
Information provided by:	Astellas Pharma Inc
ClinicalTrials.gov Identifier:	NCT00699049

Purpose

The purpose of this study is to explore the additional benefit of solifenacin after 12 weeks treatment, compared with tamsulosin monotherapy in men with residual OAB symptoms

Condition	Intervention	Phase
Urinary Bladder, Overactive	Drug: tamsulosin Drug: placebo Drug: solifenacin	Phase IV

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 Comparison of the Efficacy and Safety of Tamsulosin Monotherapy and Tamsulosin Plus Solifenacin in Men With a Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency With/Without Urgency Incontinence After Previous Monotherapy With Tamsulosin

Resource links provided by NLM:

MedlinePlus related topics: Urinary Incontinence

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:

Achievement level of patients' individual satisfaction [ Time Frame: At weeks 4 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Changes in urgency episodes [ Time Frame: At weeks 4 and 12 ] [ Designated as safety issue: No ]
Changes in OAB symptom scores [ Time Frame: At weeks 4 and 12 ] [ Designated as safety issue: No ]
Changes in QoL score by OAB-q [ Time Frame: At weeks 4 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment:	103
Study Start Date:	June 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 and placebo	Drug: tamsulosin oral Drug: placebo oral
2: Experimental tamsulosin and solifenacin	Drug: tamsulosin oral Drug: solifenacin oral

Eligibility

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

Criteria

Inclusion Criteria:

Persistent symptoms of OAB as verified by the 3 day voiding diary, defined by:
- symptoms of urinary urgency (defined as a level of >=3 in a 5 point urgency scale) at least two episode per 24 hours and
- symptoms of urinary frequency ( >8 micturitions per 24 hours)
On a stable dose of tamsulosin for at least 1 month

Exclusion Criteria:

Previous history of acute urinary retention
Patients have a baseline post-void residual (PVR) which exceeded 50% of voided urine volume
Any condition that is a contraindication for anticholinergic treatment, including uncontrolled narrow-angled glaucoma, urinary retention or gastric retention
Symptomatic acute urinary tract infection (UTI) during the screening period
Treatment within the 14 days preceding randomization, or expected to initiate treatment during the study with any anticholinergic drugs and drug treatment for overactive bladder
A 5-alpha reductase inhibitor if started less than 3 months prior to screening
Patients with previous urethral, prostate or bladder neck surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00699049

Contacts

Contact: Clinical Development Administration Department

clinicaltrials_info@jp.astellas.com

Locations

Korea, Republic of
	Recruiting
Seoul, Korea, Republic of
	Recruiting
Pusan, Korea, Republic of
	Recruiting
Cheonan, Korea, Republic of

Sponsors and Collaborators

Astellas Pharma Inc

Investigators

Study Chair:

Central Contact

Astellas Pharma Inc

More Information

No publications provided

Responsible Party:	Astellas Pharma, Inc ( Director )
Study ID Numbers:	SMK-1
Study First Received:	June 16, 2008
Last Updated:	February 23, 2009
ClinicalTrials.gov Identifier:	NCT00699049 History of Changes
Health Authority:	Korea: Food and Drug Administration

Keywords provided by Astellas Pharma Inc:

Tamsulosin
Solifenacin
Overactive Bladder
Urgency incontinence

Study placed in the following topic categories:

Urinary Bladder, Overactive
Neurotransmitter Agents
Cystocele
Cholinergic Antagonists
Adrenergic Agents
Urinary Bladder Diseases
Adrenergic alpha-Antagonists
Cholinergic Agents

Muscarinic Antagonists
Signs and Symptoms
Urologic Diseases
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Tamsulosin
Urinary Incontinence
Adrenergic Antagonists

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 August 28, 2009