NCT03594058已完成2 期
A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Oral Solabegron Modified Release Tablets in the Treatment of Overactive Bladder (OAB) in Adult Female Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,413
- 试验地点
- 65
- 主要终点
- Change from Baseline in mean number of micturitions per 24 hours at Week 12
研究概览
简要总结
This is a Phase 2b, multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of solabegron modified release low dose or high dose tablets, compared to matched placebo, administered once daily for 12 weeks to adult female subjects with overactive bladder symptoms (frequency, urgency, and predominantly urgency incontinence) for at least 6 months.
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)
盲法说明
Sponsor representatives Site monitors Data managers Statistician
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult female subjects 18 to 80 years of age, with a ≥ 6-month history of symptoms of overactive bladder including: frequency, urgency, urgency urinary incontinence, and mixed incontinence. Subjects must provide written informed consent and either be of non-childbearing potential or of childbearing potential meeting specific criteria (e.g., negative pregnancy test, sexual inactivity, acceptable methods of birth control, and use of hormonal contraceptives).
排除标准
- •Subjects must have no history of pelvic or bladder disease, e.g., uterine prolapse, malignancy, prior surgery, or treatment with botulinum toxin.
- •Diabetes insipidus or poorly controlled Type 1 or Type 2 diabetes mellitus
- •Cardiac conditions:
- •prior cardiovascular events or procedures within 6 months of screening
- •congestive heart failure
- •abnormal ECG findings, including ECG QT correction interval (QTc) > 470 msec at the Screening Visit
- •systolic blood pressure ≥ 180 mmHg or diastolic blood pressure ≥ 100 mmHg, or heart rate > 100 beats per minute
- •Abnormal tests of liver function
- •History of prior infection due to HIV or hepatitis B or hepatitis C virus
- •Allergy or hypersensitivity to solabegron or mirabegron
- •Women of childbearing potential: breastfeeding, pregnant, or actively trying to become pregnant
- •Participation in a trial of an investigational or marketed drug ≤ 30 days prior to the Screening Visit or in any clinical trial of an investigational drug that may affect urinary function within 3 months prior to Screening Visit.
- •Inability to read, understand, or complete study-related materials
研究组 & 干预措施
Solabegron modified release tablets low dose
Experimental
干预措施: Solabegron modified release tablets, low dose (Drug)
Solabegron modified release tablets high dose
Experimental
干预措施: Solabegron modified release tablets, high dose (Drug)
Placebo Comparator
Placebo Comparator
干预措施: Matching Placebo (Drug)
结局指标
主要结局
Change from Baseline in mean number of micturitions per 24 hours at Week 12
时间窗: Micturtions will be assessed prior to randomization and at Week 12 (Visit 6).
Micturition events will be recorded by subjects in an eDiary using a smartphone device during 3-day diary periods prior to randomization and at 12 weeks.
次要结局
- Micturitions (2)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Micturitions (4)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Urine Void Volume (1)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Urine Void Volume (2)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Micturitions (3)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Urine Void Volume (3)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Urine Void Volume (4)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Urgency (1)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Urgency (2)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Patient Reported Outcomes (1)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Patient Reported Outcomes (2)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Patient Reported Outcomes (3)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Urinary Incontinence (3)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Urinary Incontinence (4)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Urinary Incontinence (5)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Micturitions (1)(Prior to Randomization (Baseline) and at Weeks 4 and 8)
- Urinary Incontinence (1)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
- Urinary Incontinence (2)(Prior to Randomization (Baseline) and at Weeks 4, 8, and 12)
研究者
研究点 (65)
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