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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 16, 2008

Last Updated Date

February 23, 2009

Start Date ^†

June 2008

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00699049 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

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

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

Brief Summary

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

Detailed Description

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

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

Condition ^†

Urinary Bladder, Overactive

Intervention ^†

Drug: tamsulosin
Drug: placebo
Drug: solifenacin

Study Arms / Comparison Groups

Placebo Comparator: tamsulosin and placebo
Experimental: tamsulosin and solifenacin

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

103

Estimated Completion Date

December 2009

Estimated Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Male

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^††

Contact: Clinical Development Administration Department

clinicaltrials_info@jp.astellas.com

Location Countries ^†

Korea, Republic of

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00699049

Responsible Party

Director, Astellas Pharma, Inc

Secondary IDs ^††

Study Sponsor ^†

Astellas Pharma Inc

Collaborators ^††

Investigators ^†

Study Chair:

Central Contact

Astellas Pharma Inc

Information Provided By

Astellas Pharma Inc

Verification Date

February 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.