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

Astellas

Status and phase: Completed; Phase 3

Conditions: Urinary Bladder, Overactive

Treatments: Drug: tolterodine; Drug: YM178; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00966004

178-CL-048

Details and patient eligibility

About

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

Full 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).

Enrollment: 1,139 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,139 participants in 3 patient groups, including a placebo group

YM178 group

Experimental group

Description:

oral

Treatment:

Drug: YM178

Placebo group

Placebo Comparator group

Description:

oral

Treatment:

Drug: Placebo

tolterodine group

Active Comparator group

Description:

oral

Treatment:

Drug: tolterodine