A Study to Evaluate Safety and Efficacy of YM178 in Patients With Overactive Bladder
Information source: Astellas Pharma Inc
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Urinary Bladder, Overactive
Intervention: YM178 (Drug); Placebo (Drug); tolterodine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Astellas Pharma Inc Official(s) and/or principal investigator(s): Use Central Contact, Study Chair, Affiliation: Astellas Pharma Inc
Summary
The purpose of the study is to evaluate the effect of YM178 in patients with overactive
bladder for 12-week administration.
Clinical Details
Official title: Phase III Study of YM178 - A Placebo-controlled, Double-blind, Group Comparison Study in Patients With Overactive Bladder
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change from baseline in the mean number of micturitions per 24 hours
Secondary outcome: Change from baseline in the mean number of urgency episodes per 24 hoursChange from baseline in the mean number of urinary incontinence episode per 24 hours Change from baseline in the mean number of urge incontinence episodes per 24 hours Change from baseline in the mean volume voided per micturition Change from baseline in mean number of nocturia episodes Change from baseline in domain score of quality of life scores as assessed by King's health questionnaire
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).
Eligibility
Minimum age: 20 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Chubu, Japan
Kantou, Japan
Kinki, Japan
Kyushu, Japan
Additional Information
Link to Results on JAPIC
Starting date: July 2009
Last updated: July 15, 2013
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