Study Evaluating the Safety, Tolerability, and Efficacy of Dexmecamylamine (TC-5214) for Treatment of Overactive Bladder
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,635
- 试验地点
- 110
- 主要终点
- Change from baseline in micturition frequency per 24 hours
研究概览
简要总结
Overactive bladder (OAB) is a syndrome characterized by symptoms of a sudden need to urinate with or without incontinence (leaking). The purpose of this study is to test whether dexmecamylamine is safe and effective compared to placebo for the treatment of symptoms of OAB.
详细描述
The study included a three- or five-week screening period, followed by a 12-week treatment period during which patients received either one of three doses of dexmecamylamine or placebo twice daily, randomized in a ratio of 2:1:1:1 (placebo, low dose, mid dose, high dose), with a two-week follow-up period. A total of 768 subjects with overactive bladder were randomized into the double-blind treatment period of the study.
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
- •Verified medical history of overactive bladder for at least 6 months
- •Capable of walking unassisted to use the bathroom
- •Able to measure voided urine volume and complete the diary without assistance
- •If the subject is currently being treated with an OAB medication, the subject is willing to discontinue OAB medications while participating in this study
排除标准
- •Diagnosis of a neurological disease affecting bladder function
- •Stress incontinence, insensate incontinence, overflow incontinence or incontinence due to urinary fistula
- •History of incomplete bladder emptying, bladder outflow obstruction or post-void residual bladder volume > 150 mL
- •Males with benign prostatic hyperplasia or with a prostate-specific antigen (PSA) of 4 ng/mL or more
- •Other urinary tract pathology such as malignancy, ureteric reflux, bladder stone, uninvestigated hematuria, urethral stricture, or cystitis
- •Prior treatment with intravesical or intraprostatic botulinum toxin in the last 2 years
- •Myasthenia gravis
- •Angle closure glaucoma
- •Current implantation of interstim electrodes or vaginal surgical mesh
- •Presence of a clinically significant medical condition at any time during the study
- •Presence of clinically significant abnormalities in laboratory findings, physical exam findings or vital signs
- •Participated in an investigational drug trial within 3 months of screening
研究组 & 干预措施
Placebo
One tablet of placebo to be administered orally twice a day.
干预措施: Placebo (Drug)
0.5 mg dexmecamylamine (TC-5214)
One tablet of 0.5 mg dexmecamylamine to be administered orally twice a day.
干预措施: dexmecamylamine (Drug)
1 mg dexmecamylamine (TC-5214)
One tablet of 1 mg dexmecamylamine to be administered orally twice a day.
干预措施: dexmecamylamine (Drug)
2 mg dexmecamylamine (TC-5214)
One tablet of 2 mg dexmecamylamine to be administered orally twice a day.
干预措施: dexmecamylamine (Drug)
结局指标
主要结局
Change from baseline in micturition frequency per 24 hours
时间窗: 12 weeks
Micturition: Any voiding episode recorded by the patient as "urinated" either with or without incontinence.
Change from baseline in urinary urge incontinence (UUI) episodes per 24 hours
时间窗: 12 weeks
次要结局
- Change from baseline in Patient Perception of Bladder Condition (PPBC)(12 weeks)
- Change from baseline in the volume voided per micturition(12 weeks)
- Change from baseline in nocturia per 24 hours(12 weeks)
- Clinical Global Impression of Improvement (CGI-I)(12 weeks)
- Change from baseline in the Urgency Questionnaire(12 weeks)
- Change from baseline in disease specific quality of life (OABq)(12 weeks)