NCT01638000已完成3 期
A Double-Blind, Randomized, Parallel Group, Multi-Centre Study to Evaluate the Efficacy and Safety of Mirabegron Compared to Solifenacin in Subjects With Overactive Bladder (OAB) Treated With Antimuscarinics and Dissatisfied Due to Lack of Efficacy
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
- 1,887
- 试验地点
- 217
- 主要终点
- Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours
研究概览
简要总结
The purpose of the study was to assess the efficacy, safety and tolerability of mirabegron 50 mg versus (vs) solifenacin 5 mg in the treatment of patients with OAB who were dissatisfied with their treatment due to lack of efficacy.
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
- •Subject is willing and able to complete the micturition diary and questionnaires correctly
- •Subject has symptoms of OAB (urinary frequency and urgency with or without urgency incontinence) for at least 3 months
- •Subject is currently or has previously received at least one antimuscarinic agent intended to treat their OAB. The last antimuscarinic must have been taken for at least 4 weeks and taken within 6 months prior to the Screening Visit
排除标准
- •Female subject is breastfeeding, pregnant, intends to become pregnant during the study, or of childbearing potential is sexually active and not practicing a highly reliable method of birth control
- •Subject has neurogenic bladder
- •Subject has significant stress incontinence or mixed stress/urgency incontinence where stress is the predominant factor as determined by the investigator (for female subjects confirmed by a cough provocation test)
- •Subject has an indwelling catheter or practices intermittent self-catheterization
- •Subject has diabetic neuropathy
- •Subject 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
- •Subject has uncontrolled narrow angle glaucoma, urinary or gastric retention, severe ulcerative colitis, toxic megacolon, myasthenia gravis or any other medical condition which makes the use of anticholinergics contraindicated
- •The subject is currently receiving or has a history of treatment with intravesical botulinum toxin (cosmetic use is acceptable) or resiniferatoxin within 9 months prior to screening
- •Subject receives non-drug treatment including electro-stimulation therapy (with the exception of a bladder training program or pelvic floor exercises which started more than 30 days prior to screening)
- •Subject has moderate to severe hepatic impairment
- •Subject has severe renal impairment or end stage renal disease
- •Subject has severe uncontrolled hypertension
- •Subject has a clinically significant abnormal electrocardiogram (ECG) or has a known history of QT prolongation or currently taking medication known to prolong the QT interval
- •Subject has a known or suspected hypersensitivity to solifenacin, mirabegron or any of the inactive ingredients
- •Subject has a concurrent malignancy or history of cancer (except noninvasive skin cancer) within the last 5 years prior to screening
- •Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives
- •Subject is using prohibited medications which cannot be stopped safely at the Screening Visit. Subject is excluded if using restricted medications not meeting protocol-specified criteria
- •Subject's last antimuscarinic treatment was solifenacin
研究组 & 干预措施
Solifenacin 5 mg
Active Comparator
Participants who received solifenacin 5 mg once daily for 12 weeks.
干预措施: Solifenacin succinate (Drug)
Mirabegron 50 mg
Experimental
Participants who received mirabegron 50 mg once daily for 12 weeks.
干预措施: Mirabegron (Drug)
结局指标
主要结局
Change From Baseline to Final Visit in the Mean Number of Micturitions Per 24 Hours
时间窗: Baseline and final visit (up to Week 12)
A micturition is any voluntary urination (excluding incontinence only episodes). The mean number of micturitions per 24 hours were calculated from the data recorded by the participant during the 3-day micturition diary period.
次要结局
- Percentage of Participants With Major Improvement in PPBC: ≥2 Point Improvement at Week 12 and Final Visit(Baseline to Week 12)
- Percentage of Participants With 50% Reduction in Incontinence Episodes at Weeks 4, 8, 12 and Final Visit(Week 4, Week 8, Week 12)
- Percentage of Participants With Zero Incontinence Episodes at Weeks 4, 8, 12 and Final Visit(Week 4, Week 8, Week 12)
- Change From Baseline to Week 4 in Mobility Scores as Assessed by the European Quality of Life 5-Dimensions (EQ-5D-5L) Questionnaire(Baseline and Week 4)
- Percentage of Participants Reporting at Least One Treatment-emergent Adverse Event of Dry Mouth, Constipation or Blurred Vision During Double-blind Treatment Period(From first dose of study drug up to 30 days after last dose of study drug (up to 16 weeks))
- Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Micturitions Per 24 Hours(Baseline and Week 4, Week 8, Week 12)
- Number of Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit(Week 4, Week 8, Week 12)
- Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Incontinence Episodes Per 24 Hours(Baseline and Week 4, Week 8, Week 12)
- Number of Urgency Incontinence Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit(Week 4, Week 8, Week 12)
- Change From Baseline to 4, 8 and 12 Weeks of Treatment in Mean Number of Urgency Incontinence Episodes Per 24 Hours(Baseline and Week 4, Week 8, Week 12)
- Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Number of Urgency Episodes (Grade 3 or 4) Per 24 Hours(Baseline and Week 4, Week 8, Week 12)
- Change From Baseline to 4, 8 and 12 Weeks of Treatment and at the Final Visit in Mean Level of Urgency(Baseline and Week 4, Week 8, Week 12)
- Number of Pads Used at 4, 8 and 12 Weeks of Treatment and at the Final Visit(Week 4, Week 8, Week 12)
- Change From Baseline in Mean Number of Pads Used Per 24 Hours After 4, 8 and 12 Weeks of Treatment(Baseline and Week 4, Week 8 , Week 12)
- Number of Nocturia Episodes at 4, 8 and 12 Weeks of Treatment and at the Final Visit(Week 4, Week 8, Week 12)
- Change From Baseline in Mean Number of Nocturia Episodes Per 24 Hours After 4, 8 and 12 Weeks of Treatment(Baseline and Week 4, Week 8, Week 12)
- Percentage of Participants With Normalization of Micturitions at Weeks 4, 8, 12 and Final Visit(Week 4, Week 8, Week 12)
- Change From Baseline to Week 4 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 4)
- Change From Baseline to Week 4 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 4)
- Change From Baseline to Week 4 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 4)
- Change From Baseline to Week 4 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 4)
- Change From Baseline to Week 8 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 8)
- Change From Baseline to Week 8 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 8)
- Change From Baseline to Week 8 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 8)
- Change From Baseline to Week 8 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 8)
- Change From Baseline to Week 8 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 8)
- Change From Baseline to Week 12 in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 12)
- Change From Baseline to Week 12 in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 12)
- Change From Baseline to Week 12 in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 12)
- Change From Baseline to Week 12 in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 12)
- Change From Baseline to Week 12 in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and Week 12)
- Change From Baseline to Final Visit in Mobility Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and final visit (up to Week 12))
- Change From Baseline to Final Visit in Self-care Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and final visit (up to Week 12))
- Change From Baseline to Final Visit in Usual Activities Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and final visit (up to Week 12))
- Percentage of Participants With Improvement in Symptom Bother Score as Assessed by the OAB-q: ≥ 10 Points Improvement in OAB-q at Week 12 and Final Visit(Baseline to Week 12)
- Change From Baseline to Final Visit in Pain/Discomfort Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and final visit (up to Week 12))
- Change From Baseline to Final Visit in Anxiety/Depression Scores as Assessed by the EQ-5D-5L Questionnaire(Baseline and final visit (up to Week 12))
- Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Symptom Bother Score as Assessed by the Overactive Bladder Questionnaire (OAB-q)(Baseline and Week 4, Week 8, Week 12)
- Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Total Health-Related Quality of Life (HRQoL) Score as Assessed by the OAB-q(Baseline and Week 4, Week 8, Week 12)
- Change From Baseline to Weeks 4, 8, 12, and at the Final Visit in Patient Perception of Bladder Condition (PPBC)(Baseline and Week 4, Week 8, Week 12)
- Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction (TS)-Visual Analog Scale (VAS)(Baseline and Week 12)
- Percentage of Participants With Improvement in HRQoL Scales as Assessed by the OAB-q: ≥10 Points Improvement in OAB-q at Week 12 and Final Visit(Baseline to Week 12)
- Percentage of Participants With Improvement in PPBC: ≥1 Point Improvement at Week 12 and Final Visit(Baseline to Week 12)
- Change From Baseline to Week 12 and the Final Visit in the Patient's Assessment of Treatment Satisfaction Questionnaire-Likert Scale(Baseline and Week 12)
- Percentage of Participants With Improvement of Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Week 12(Baseline to Week 12)
- Percentage of Participants With Improvement in Treatment Satisfaction Questionnaire - Likert Scale: ≥1, ≥2, ≥3, ≥4, ≥5, and 6-point Improvement From Baseline to Final Visit(Baseline to final visit (up to Week 12))
研究者
研究点 (217)
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