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A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00699049
Recruitment Status : Completed
First Posted : June 17, 2008
Last Update Posted : January 7, 2016
Sponsor:
Collaborator:
Astellas Pharma Korea, Inc.
Information provided by (Responsible Party):
KYU-SUNG LEE, Samsung Medical Center

Tracking Information
First Submitted Date  ICMJE June 16, 2008
First Posted Date  ICMJE June 17, 2008
Last Update Posted Date January 7, 2016
Study Start Date  ICMJE June 2008
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
Achievement level of patients' individual satisfaction [ Time Frame: At weeks 4 and 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 16, 2008)
  • Changes in urgency episodes [ Time Frame: At weeks 4 and 12 ]
  • Changes in OAB symptom scores [ Time Frame: At weeks 4 and 12 ]
  • Changes in QoL score by OAB-q [ Time Frame: At weeks 4 and 12 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study Comparing the Efficacy of an Alpha Blocker Versus an Alpha Blocker Plus Solifenacin in Men With Overactive Bladder
Official Title  ICMJE A Randomized, Double Blind, Placebo-Controlled, Parallel Group Comparison of the Efficacy and Safety of Any Alpha Blocker Monotherapy and Any Alpha Blocker Plus Solifenacin in Men With Residual Overactive Bladder Symptoms of Urinary Frequency and Urgency With/Without Urgency Incontinence After Previous Monotherapy With Any Alpha Blocker
Brief Summary The purpose of this study is to explore additional benefit of solifenacin after 12-week treatment, compared with alpha blocker monotherapy in men with residual OAB symptoms.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Urinary Bladder, Overactive
Intervention  ICMJE
  • Drug: Alpha blocker
    oral
  • Drug: placebo
    oral
  • Drug: solifenacin
    oral
    Other Names:
    • Vesicare
    • YM905
Study Arms  ICMJE
  • Placebo Comparator: Alpha blocker and placebo
    Interventions:
    • Drug: Alpha blocker
    • Drug: placebo
  • Experimental: Alpha blocker and solifenacin
    Interventions:
    • Drug: Alpha blocker
    • Drug: solifenacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2010)
94
Original Estimated Enrollment  ICMJE
 (submitted: June 16, 2008)
103
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00699049
Other Study ID Numbers  ICMJE SMK-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party KYU-SUNG LEE, Samsung Medical Center
Study Sponsor  ICMJE KYU-SUNG LEE
Collaborators  ICMJE Astellas Pharma Korea, Inc.
Investigators  ICMJE
Study Chair: Central Contact Astellas Pharma Inc
PRS Account Samsung Medical Center
Verification Date January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP