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

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ClinicalTrials.gov Identifier: NCT00966004
Recruitment Status : Completed
First Posted : August 26, 2009
Last Update Posted : February 16, 2017
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc

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

Condition or disease Intervention/treatment Phase
Urinary Bladder, Overactive Drug: YM178 Drug: Placebo Drug: tolterodine Phase 3

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).


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1139 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : February 2010
Actual Study Completion Date : February 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. Change from baseline in the mean number of urgency episodes per 24 hours [ Time Frame: Within a 12-week treatment period ]
  2. Change from baseline in the mean number of urinary incontinence episode per 24 hours [ Time Frame: Within a 12-week treatment period ]
  3. Change from baseline in the mean number of urge incontinence episodes per 24 hours [ Time Frame: Within a 12-week treatment period ]
  4. Change from baseline in the mean volume voided per micturition [ Time Frame: Within a 12-week treatment period ]
  5. Change from baseline in mean number of nocturia episodes [ Time Frame: Within a 12-week treatment period ]
  6. 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 ]


Information from the National Library of Medicine

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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

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

Additional Information:
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT00966004     History of Changes
Other Study ID Numbers: 178-CL-048
First Posted: August 26, 2009    Key Record Dates
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