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A Study of YM178 in Patients With Symptomatic Overactive Bladder

Primary Purpose

Urinary Bladder, Overactive

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

YM178

Placebo

About this trial

This is an interventional treatment trial for Urinary Bladder, Overactive focused on measuring YM178, Urinary Bladder, Overactive

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients over 20 years suffering from overactive bladder

Exclusion Criteria:

Pregnant and breastfeeding women
Any clinically significant abnormal conditions which in the opinion of the investigator makes the patient unsuitable for the study

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Arm Label

Arm Description

Oral

Outcomes

Primary Outcome Measures

Overactive bladder symptoms

Secondary Outcome Measures

Overactive bladder symptoms (QOL)

Full Information

NCT ID

NCT00527033

First Posted

September 6, 2007

Last Updated

February 14, 2017

Sponsor

Astellas Pharma Inc

1. Study Identification

Unique Protocol Identification Number

NCT00527033

Brief Title

A Study of YM178 in Patients With Symptomatic Overactive Bladder

Official Title

A Randomized, Double-blind, Parallel-group, Placebo-controlled Study in Patients With Symptomatic Overactive Bladder

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

September 2007 (undefined)

Primary Completion Date

April 2008 (Actual)

Study Completion Date

April 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Astellas Pharma Inc

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Examine which dose of YM178 is the best in terms of efficacy, safety and tolerability compared to placebo

Detailed Description

To investigate the dose-response relationship of YM178 in terms of efficacy, safety and tolerability, and also the superiority of YM178 over placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Bladder, Overactive

Keywords

YM178, Urinary Bladder, Overactive

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

842 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Oral

Arm Title

Arm Type

Experimental

Arm Description

Oral

Arm Title

Arm Type

Experimental

Arm Description

Oral

Arm Title

Arm Type

Placebo Comparator

Arm Description

Oral

Intervention Type

Drug

Intervention Name(s)

YM178

Intervention Description

Oral

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Oral

Primary Outcome Measure Information:

Title

Overactive bladder symptoms

Time Frame

12 weeks

Secondary Outcome Measure Information:

Title

Overactive bladder symptoms (QOL)

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients over 20 years suffering from overactive bladder Exclusion Criteria: Pregnant and breastfeeding women Any clinically significant abnormal conditions which in the opinion of the investigator makes the patient unsuitable for the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Central Contact

Organizational Affiliation

Astellas Pharma Inc

Official's Role

Study Chair

Facility Information:

City

Chubu

Country

Japan

City

Hokkaido

Country

Japan

City

Kansai

Country

Japan

City

Kanto

Country

Japan

City

Kyusyu

Country

Japan

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Details of the IPD sharing plan for this study can be found at www.clinicalstudydatarequest.com.

Citations:

PubMed Identifier

26663687

Citation

Yamaguchi O, Marui E, Igawa Y, Takeda M, Nishizawa O, Ikeda Y, Ohkawa S. Efficacy and Safety of the Selective beta3 -Adrenoceptor Agonist Mirabegron in Japanese Patients with Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled, Dose-Finding Study. Low Urin Tract Symptoms. 2015 May;7(2):84-92. doi: 10.1111/luts.12053. Epub 2014 Mar 11.

Results Reference

derived

Links:

URL

https://www.astellasclinicalstudyresults.com/hcp/study.aspx?ID=166

Description

Link to results on Astellas Clinical Study Results website

Learn more about this trial

A Study of YM178 in Patients With Symptomatic Overactive Bladder

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