We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00966004
First Posted: August 26, 2009
Last Update Posted: February 16, 2017
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.
Information provided by (Responsible Party):
Astellas Pharma Inc
  Purpose
The purpose of the study is to evaluate the effect of YM178 in patients with overactive bladder for 12-week administration.

Condition Intervention Phase
Urinary Bladder, Overactive Drug: YM178 Drug: Placebo Drug: tolterodine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Change from baseline in the mean number of micturitions per 24 hours [ Time Frame: Within a 12-week treatment period ]

Secondary Outcome Measures:
  • Change from baseline in the mean number of urgency episodes per 24 hours [ Time Frame: Within a 12-week treatment period ]
  • Change from baseline in the mean number of urinary incontinence episode per 24 hours [ Time Frame: Within a 12-week treatment period ]
  • Change from baseline in the mean number of urge incontinence episodes per 24 hours [ Time Frame: Within a 12-week treatment period ]
  • Change from baseline in the mean volume voided per micturition [ Time Frame: Within a 12-week treatment period ]
  • Change from baseline in mean number of nocturia episodes [ Time Frame: Within a 12-week treatment period ]
  • 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 ]

Enrollment: 1139
Study Start Date: July 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: YM178 group
oral
Drug: YM178
oral
Other Name: mirabegron
Placebo Comparator: Placebo group
oral
Drug: Placebo
oral
Active Comparator: tolterodine group
oral
Drug: tolterodine
oral
Other Names:
  • Detrol
  • Detrusitol

Detailed Description:

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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00966004


Locations
Japan
Chubu, Japan
Kantou, Japan
Kinki, Japan
Kyushu, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Use Central Contact Astellas Pharma Inc
  More Information

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00966004     History of Changes
Other Study ID Numbers: 178-CL-048
First Submitted: August 24, 2009
First Posted: August 26, 2009
Last Update Posted: February 16, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

Keywords provided by Astellas Pharma Inc:
Urge incontinence
YM178
Overactive Bladder
Urgency
Urinary incontinence
mirabegron
Micturition

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Mirabegron
Tolterodine Tartrate
Adrenergic beta-3 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents