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

NCT00966004 | Completed Phase 3

• 1 other identifier: 178-CL-048
• Study Type: interventional
• Target: 1,139
• Locations: 1 country
• Sites: 4

Brief Summary

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

Conditions

Urinary Bladder, Overactive

Keywords

Urge incontinence; YM178; Overactive Bladder; Urgency; Urinary incontinence; mirabegron; Micturition

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the mean number of micturitions per 24 hours

  Within a 12-week treatment period

Secondary Outcomes (6)

• 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

Study Arms (3)

YM178 group

EXPERIMENTAL

oral

Drug: YM178

Placebo group

PLACEBO COMPARATOR

oral

Drug: Placebo

tolterodine group

ACTIVE COMPARATOR

oral

Drug: tolterodine

Interventions

YM178 DRUG

oral

Also known as: mirabegron

YM178 group

Placebo DRUG

oral

Placebo group

tolterodine DRUG

oral

Also known as: Detrol, Detrusitol

tolterodine group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma Inc: lead

Study Sites (4)

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Kantou, Japan

Location

Unknown Facility

Kinki, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Related Publications (1)

• Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.

  PMID: 37160401 DERIVED

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence, Urge; Urinary Incontinence

Interventions

mirabegron; Tolterodine Tartrate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Phenylpropanolamine; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Cresols; Phenols

Study Officials

• Use Central Contact

  Astellas Pharma Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2009
• First Posted: August 26, 2009
• Study Start: July 24, 2009
• Primary Completion: February 15, 2010
• Study Completion: February 15, 2010
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

JP (4)