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
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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 Drug: YM178
oral
Other Name: mirabegron
Placebo Comparator: Placebo group Drug: Placebo
oral
Active Comparator: tolterodine group 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

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00966004     History of Changes
Other Study ID Numbers: 178-CL-048
Study First Received: August 24, 2009
Last Updated: July 15, 2013
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

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

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine
Mirabegron
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 27, 2014