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NCT00840645 Clinical Trial

A Long-term Study of YM178 in Symptomatic Overactive Bladder Patients

Urinary Bladder, Overactive Clinical Trial

Official title:
Long-term Study of YM178: Long Term Study of YM178 in Subjects With Overactive Bladder

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00840645
Other study ID # 178-CL-051
Secondary ID
Status Completed
Phase Phase 3
First received February 8, 2009
Last updated January 4, 2016
Start date December 2008
Est. completion date March 2010

Study information
Verified date January 2016
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Japan: Pharmaceuticals and Medical Devices Agency
Study type Interventional

Clinical Trial Summary

The study is intended to test the safety, tolerability, and efficacy of long-term treatment with YM178 in patients with overactive bladder symptoms.

Recruitment information / eligibility
Status Completed
Enrollment 204
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- Subject has symptoms of overactive bladder for >= 24 wks

- Subject experiences frequency of micturition at average >= 8 times per 24 hrs confirmed by the 3-day patient diary

Exclusion Criteria:

- Subject is breastfeeding, pregnant, or intends to become pregnant during the study

- Subject obviously has stress incontinence

- Subject has an indwelling catheter or practices intermittent self catheterization

- Subject has evidence of symptomatic urinary tract infection, interstitial cystitis, bladder stone, etc

- Subject has an average total daily urine volume > 3000 mL confirmed by patient diary

- Subject has uncontrollable hypertension (SBP >= 180 mmHg or DBP >= 110 mmHg)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• YM178
Oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Vital signs, AEs, lab tests, ECG, post-void residual volume 52 weeks Yes
Secondary Changes from baseline in the mean number of micturitions/24hrs 52 weeks No
Secondary Changes from baseline in the mean number of urinary urgencies/24 hrs 52 weeks No
Secondary Changes from baseline in the mean number of incontinence episodes/24 hrs 52 weeks No
Secondary Changes from baseline in the mean number of urge incontinence episodes/24 hrs 52 weeks No
Secondary Changes from baseline in the mean number of nocturnal urinations 52 weeks No
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