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Completed

NCT Number: NCT01043666

A Study of YM178 in Subjects With Symptoms of Overactive Bladder

This study is to assess the efficacy and safety of YM178 in patients with symptoms of overactive bladder.

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Key information

Conditions

Urinary Bladder, Overactive Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Incontinence Urinary Incontinence, Urge Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with symptoms of overactive bladder for at least 12 weeks before the study
  • Subjects capable of walking to the lavatory without assistance and measuring the urine volume by him/herself
  • Subject with an average frequency of micturition of 8 or more times per 24-hour period
  • Subject with an average episode of urgency or urge incontinence of one or more times per 24-hours period
  • Subject having provided written informed consent by him/herself

Exclusion criteria

  • Subject having stress urinary incontinence as a predominant symptom
  • Subject with transient symptoms suspected for overactive bladder
  • Subject complicated with urinary tract infection, urinary stones, and/or interstitial cystitis or with a historical condition of recurrent urinary tract infection
  • Subject complicated with bladder tumor/prostatic tumor or with the historical condition
  • Subject confirmed to have a post-void residual volume of >=100ml or with a clinically significant lower urinary tract obstructive disease
  • Subject with indwelling catheter or practicing intermittent self-catheterization
  • Subject giving radiotherapy influencing urinary tract functions, or thermotherapy for benign prostatic hyperplasia
  • Subject giving surgical therapy which may influence urinary tract functions within 24 weeks before the study
  • Subject with uncontrolled hypertension (indicated by sitting SBP >=180mmHg or DPB >= 110mmHg)
  • Subject with a pulse rate >= 110bpm or <50 bpm

Treatment and study plan

YM178

Drug

oral

Other names: mirabegron

Placebo

Drug

oral

Tolterodine ER

Drug

oral

Other names: Detrusitol SR

Primary outcomes

  1. Change in mean number of micturitions per 24 hrs

    Time frame: Within a 12-week treatment period

Secondary outcomes

  1. Change in mean number of urgency episodes per 24 hrs

    Time frame: Within a 12-week treatment period

  2. Change in mean number of urinary incontinence episodes per 24 hrs

    Time frame: Within a 12-week treatment period

  3. Change in mean number of urge incontinence episodes per 24 hrs

    Time frame: Within a 12-week treatment period

  4. Change in mean volume voided per micturition

    Time frame: Within a 12-week treatment period

  5. Change in mean number of nocturia episodes

    Time frame: Within a 12-week treatment period

  6. Safety assessed by vital signs, adverse events laboratory findings, 12-lead electrocardiogram and post-void residual volume

    Time frame: During 12-week treatment

Sponsors and collaborators

Lead sponsor

Astellas Pharma Inc

Industry

Registry information

Official study title

Phase III Study of YM178: A Randomized, Double-blind, Parallel Group, Placebo and Active Controlled, Multi-center Study in Subjects With Symptoms of Overactive Bladder

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 7, 2010
Registry last updated
Oct 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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