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.

Study Overview

• Status: Completed
• Conditions: Urinary Bladder, Overactive
• Intervention / Treatment: Drug: Placebo; Drug: tolterodine; Drug: YM178

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
• Enrollment (Actual): 1139
• Phase: Phase 3

Contacts and Locations

Study Locations

• Japan
  • Chubu, Japan
  • Kantou, Japan
  • Kinki, Japan
  • Kyushu, Japan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: YM178 group; oral	Drug: YM178; oral; Other Names: mirabegron
Placebo Comparator: Placebo group; oral	Drug: Placebo; oral
Active Comparator: tolterodine group; oral	Drug: tolterodine; oral; Other Names: Detrol; Detrusitol

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the mean number of micturitions per 24 hours	Within a 12-week treatment period

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the mean number of urgency episodes per 24 hours	Within a 12-week treatment period
Change from baseline in the mean number of urinary incontinence episode per 24 hours	Within a 12-week treatment period
Change from baseline in the mean number of urge incontinence episodes per 24 hours	Within a 12-week treatment period
Change from baseline in the mean volume voided per micturition	Within a 12-week treatment period
Change from baseline in mean number of nocturia episodes	Within a 12-week treatment period
Change from baseline in domain score of quality of life scores as assessed by King's health questionnaire	Within a 12-week treatment period

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Chair: Use Central Contact, Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2009
• Primary Completion (Actual): February 15, 2010
• Study Completion (Actual): February 15, 2010

Study Registration Dates

• First Submitted: August 24, 2009
• First Submitted That Met QC Criteria: August 24, 2009
• First Posted (Estimated): August 26, 2009

Study Record Updates

• Last Update Posted (Actual): October 31, 2024
• Last Update Submitted That Met QC Criteria: October 29, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Urinary incontinence; Overactive Bladder; YM178; mirabegron; Urgency; Urge incontinence; Micturition
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Lower Urinary Tract Symptoms; Urological Manifestations; Urinary Bladder Diseases; Urinary Bladder, Overactive; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Adrenergic Agonists; Adrenergic Agents; Adrenergic beta-Agonists; Adrenergic beta-3 Receptor Agonists; Urological Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Tolterodine Tartrate; Mirabegron
• Other Study ID Numbers: 178-CL-048

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as products terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.
• IPD Sharing Time Frame: Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.
• IPD Sharing Access Criteria: Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR