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A Study of YM178 in Patients With Symptomatic Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00527033
First received: September 6, 2007
Last updated: July 15, 2013
Last verified: July 2013

September 6, 2007
July 15, 2013
September 2007
April 2008   (final data collection date for primary outcome measure)
Overactive bladder symptoms [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Overactive bladder symptoms [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00527033 on ClinicalTrials.gov Archive Site
Overactive bladder symptoms (QOL) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
Overactive bladder symptoms (QOL) [ Time Frame: 12 weeks ]
Not Provided
Not Provided
 
A Study of YM178 in Patients With Symptomatic Overactive Bladder
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study in Patients With Symptomatic Overactive Bladder

Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability compared to placebo

To investigate the dose-response relationship of YM178 in terms of efficacy, safety and tolerability, and also the superiority of YM178 over placebo.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Urinary Bladder, Overactive
  • Drug: YM178
    Oral
  • Drug: Placebo
    Oral
  • Experimental: 1
    Intervention: Drug: YM178
  • Experimental: 2
    Intervention: Drug: YM178
  • Experimental: 3
    Intervention: Drug: YM178
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
842
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients over 20 years suffering from overactive bladder

Exclusion Criteria:

  • Pregnant and breastfeeding women
  • Any clinically significant abnormal conditions which in the opinion of the investigator makes the patient unsuitable for the study
Both
20 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00527033
178-CL-045
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Central Contact Astellas Pharma Inc
Astellas Pharma Inc
July 2013

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