A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT00966004
First received: August 24, 2009
Last updated: July 15, 2013
Last verified: July 2013

August 24, 2009
July 15, 2013
July 2009
February 2010   (final data collection date for primary outcome measure)
Change from baseline in the mean number of micturitions per 24 hours [ Time Frame: Within a 12-week treatment period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00966004 on ClinicalTrials.gov Archive Site
  • Change from baseline in the mean number of urgency episodes per 24 hours [ Time Frame: Within a 12-week treatment period ] [ Designated as safety issue: No ]
  • Change from baseline in the mean number of urinary incontinence episode per 24 hours [ Time Frame: Within a 12-week treatment period ] [ Designated as safety issue: No ]
  • Change from baseline in the mean number of urge incontinence episodes per 24 hours [ Time Frame: Within a 12-week treatment period ] [ Designated as safety issue: No ]
  • Change from baseline in the mean volume voided per micturition [ Time Frame: Within a 12-week treatment period ] [ Designated as safety issue: No ]
  • Change from baseline in mean number of nocturia episodes [ Time Frame: Within a 12-week treatment period ] [ Designated as safety issue: No ]
  • Change from baseline in domain score of quality of life scores as assessed by King's health questionnaire [ Time Frame: Within a 12-week treatment period ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder
Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder

The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.

This study examines the superiority of YM178 over the placebo and evaluates the safety and pharmacokinetics of YM178 in patients with overactive bladder, and to compare the efficacy and safety of YM178 over those of tolterodine, the control drug, without a non-inferiority test.

The drug administration period is 14 weeks in total, consisting of 2 weeks for placebo (pre-investigation period) and 12 weeks for the investigational drug (treatment period).

Interventional
Phase 3
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
    Other Name: mirabegron
  • Drug: Placebo
    oral
  • Drug: tolterodine
    oral
    Other Names:
    • Detrol
    • Detrusitol
  • Experimental: YM178 group
    Intervention: Drug: YM178
  • Placebo Comparator: Placebo group
    Intervention: Drug: Placebo
  • Active Comparator: tolterodine group
    Intervention: Drug: tolterodine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1139
February 2010
February 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient with symptoms of overactive bladder for at least 24 weeks before initiation of the pre-investigational period
  • Patient capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
  • Patient with an average frequency of micturition of 8 or more times per 24-hour period
  • Written informed consent has been obtained

Exclusion Criteria:

  • Patients without experience of urge incontinence before informed consent
  • Patients given a clear diagnosis of stress incontinence
  • Patients with transient symptoms suspected of overactive bladder (drug induced, psychogenic, etc)
  • Patients complicated with urinary tract infection, urinary stones, and/or interstitial cystitis
  • Patients with a previous history of recurrent urinary tract infection
  • Patients complicated with or with a history of bladder tumor or prostatic tumor
  • Patients confirmed to have a post-void residual volume of ≥ 100 mL or with a clinically significant lower urinary tract obstructive disease
  • Patients given medication for the treatment of lower urinary tract obstructive disease within 4 weeks before the pre-investigational period
  • Patients with an indwelling catheter or practicing intermittent self-catheterization
  • Patients given radiotherapy influencing urethral functions, or thermotherapy for benign prostatic hyperplasia
  • Patients given surgical therapy which may influence urethral functions within 24 weeks before the pre-investigational period
  • Patients with uncontrolled hypertension or with a pulse rate ≥ 110 bpm or < 50 bpm
  • Patients with polyuria exceeding 3000 mL in mean daily urine volume
  • Patients meeting any of the following in the examinations

    • Patients with abnormal electrocardiogram judged inappropriate as subjects by the ECG Evaluation Committee
    • Patients with AST (GOT) or ALT (GPT) 2.5 times higher than the upper limit of the normal range (or 100 IU/L)
    • Patients with a blood creatinine level ≥ 2.0 mg/dL
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00966004
178-CL-048
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Use 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