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临床试验/NCT00662909
NCT00662909已完成3 期

A Phase III, Randomized, Double-Blind, Parallel Group, Placebo Controlled, Multicenter Study to Assess the Efficacy and Safety of Mirabegron in Subjects With Symptoms of Overactive Bladder

Astellas Pharma Inc0 个研究点目标入组 2,149 人开始时间: 2008年3月28日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
2,149
主要终点
Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

The study is intended to test the efficacy, safety and tolerability of two doses of mirabegron against placebo to treat patients with symptoms of overactive bladder

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —（Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Patient is willing and able to complete the micturition diary and questionnaires correctly
  • •Patient has symptoms of overactive bladder for ≥ 3 months
  • •Patient must experience frequency of micturition on average ≥ 8 times per 24-hour period during the 3-day micturition diary period
  • •Patient must experience at least 3 episodes of urgency (grade 3 or 4) with or without incontinence during the 3-day micturition diary period

排除标准

  • •Patient is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential, sexually active and not practicing a highly reliable method of birth control
  • •Patient has significant stress incontinence or mixed stress/urge incontinence where stress is the predominant factor
  • •Patient has an indwelling catheter or practices intermittent self-catheterization
  • •Patient has diabetic neuropathy
  • •Patient has evidence of a symptomatic urinary tract infection, chronic inflammation such as interstitial cystitis, bladder stones, previous pelvic radiation therapy or previous or current malignant disease of the pelvic organs
  • •Patient receives non-drug treatment including electro-stimulation therapy
  • •Patient has severe hypertension
  • •Patient has a known or suspected hypersensitivity to YM178, other beta-adrenoreceptor (ß-AR) agonists, or any of the other inactive ingredients
  • •Patient has been treated with any investigational drug or device within 30 days
  • •Patient had an average total daily urine volume > 3000 mL as recorded in the 3-day micturition diary period
  • •Patient has serum creatinine of >150 μmol/L, or aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2x upper limit of normal range (ULN), or Gamma glutamyl transferase (γ-GT) > 3x ULN
  • •Patient has a clinically significant abnormal electrocardiogram (ECG)

研究组 & 干预措施

Placebo

Placebo Comparator

Participants received matching placebo tablets orally once a day for 12 weeks

干预措施: Placebo (Drug)

Mirabegron 50 mg

Experimental

Participants received mirabegron 50 mg tablets orally once a day for 12 weeks

干预措施: Mirabegron (Drug)

Mirabegron 100 mg

Experimental

Participants received mirabegron 100 m tablets, orally once a day for 12 weeks

干预措施: Mirabegron (Drug)

结局指标

主要结局

Change From Baseline to End of Treatment (Final Visit) in Mean Number of Incontinence Episodes Per 24 Hours

时间窗: Baseline and Week 12 (Final Visit)

The average number of incontinence episodes (any involuntary leakage of urine) per day was derived from the number of incontinence episodes recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. Least Squares (LS) Means were generated from an analysis of covariance (ANCOVA) model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

Change From Baseline to End of Treatment (Final Visit) in Mean Number of Micturitions Per 24 Hours

时间窗: Baseline and Week 12

The average number of micturitions (urinations) per 24 hours was derived from the number of times a patient urinates (excluding incontinence only episodes) per day recorded by the patient in a micturition diary for 3-days before the Baseline and Week 12 clinic visits. LS Means generated from an ANCOVA model with treatment group, gender, and geographic region as fixed factors and baseline as a covariate.

次要结局

  • Change From Baseline to Final Visit in Mean Volume Voided Per Micturition(Baseline and Week 12)
  • Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit(Weeks 4, 8 and 12)
  • Change From Baseline to Week 4 in Mean Number of Micturitions Per 24 Hours(Baseline and Week 4)
  • Change From Baseline to Week 8 and Week 12 in Mean Number of Incontinence Episodes Per 24 Hours(Baseline and Weeks 8 and 12)
  • Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Incontinence Episodes Per 24 Hours(Baseline and Weeks 4, 8 and 12)
  • Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in the European Quality of Life-5 Dimensions (EQ-5D) Visual Analog Scale (VAS)(Baseline and Weeks 4, 8 and 12)
  • Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Urgency Episodes (Grades 3 or 4) Per 24 Hours(Baseline and Weeks 4, 8 and 12)
  • Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Pads Used Per 24 Hours(Baseline and Weeks 4, 8 and 12)
  • Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Impairment While Working(Baseline and Week 12)
  • Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Overall Work Impairment(Baseline and Week 12)
  • Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Pain/Discomfort Score(Baseline and Week 12)
  • Change From Baseline to Week 4 in Mean Number of Incontinence Episodes Per 24 Hours(Baseline and Week 4)
  • Change From Baseline to Week 8 and Week 12 in Mean Number of Micturitions Per 24 Hours(Baseline and Weeks 8 and 12)
  • Change From Baseline to Week 4, Week 8 and Week 12 in Mean Volume Voided Per Micturition(Baseline and Weeks 4, 8 and 12)
  • Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Level of Urgency(Baseline and Weeks 4, 8 and 12)
  • Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Mean Number of Nocturia Episodes Per 24 Hours(Baseline and Weeks 4, 8 and 12)
  • Percentage of Participants With ≥ 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and the Final Visit(Baseline and Weeks 4, 8 and 12)
  • Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Work Time Missed(Baseline and Week12)
  • Change From Baseline to Week 12 and Final Visit in Treatment Satisfaction on Visual Analog Scale (TS-VAS)(Baseline and Week 12)
  • Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Number of Non-study Related Visits to Physician(Baseline and Weeks 4, 8 and 12)
  • Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Symptom Bother Score(Baseline and Weeks 4, 8 and 12)
  • Change From Baseline to Week 12 and Final Visit in Patient Perception of Bladder Condition (PPBC)(Baseline and Week 12)
  • Percentage of Participants With Improvement in Patient Perception of Bladder Condition (PPBC) at Week 12 and Final Visit(Baseline and Week 12)
  • Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Self-care Score(Baseline and Week 12)
  • Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Usual Activities Score(Baseline and Week 12)
  • Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Anxiety/Depression Score(Baseline and Week 12)
  • Change From Baseline to Week 4, Week 8, Week 12 and Final Visit in Health-related Quality of Life (HRQL) Total Score(Baseline and Weeks 4, 8 and 12)
  • Change From Baseline to Week 12 and Final Visit in Work Productivity and Activity Impairment (WPAI): Percent Activity Impairment(Baseline and Week 12)
  • Change From Baseline to Final Visit in European Quality of Life-5 Dimensions (EQ-5D) Mobility Score(Baseline and Week 12)

研究者

申办方类型
Industry
责任方
Sponsor

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