NCT01900704已完成3 期
A Randomized, Double Blind, Placebo Controlled, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulation in Patients With Nocturia
Serenity Pharmaceuticals, Inc.1 个研究点 分布在 1 个国家目标入组 810 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 810
- 试验地点
- 1
- 主要终点
- Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment
研究概览
简要总结
To investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female 50 years or older
- •Nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night
排除标准
- •Diabetis Insipidus
- •Renal insufficiency
- •Hepatic insufficiency
- •Incontinence
- •Illnesses requiring systemic steroids
- •Malignancy within the past 5 years
- •Sleep apnea
- •Nephrotic syndrome
- •Unexplained pelvic mass
- •Urinary bladder neurological dysfunction
- •Urinary bladder surgery or radiotherapy
- •Pregnant or breast feeding
研究组 & 干预措施
SER120 750 ng
Experimental
SER120 750 ng
干预措施: SER120 750 ng (Drug)
SER120 1500 ng
Experimental
SER120 1500 ng
干预措施: SER120 1500 ng (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Nocturic Episodes at the End of Treatment Compare to Prior to Treatment
时间窗: 12 weeks
Change was calculated based on the number of mean nocturic episodes per night between baseline through week 12
Percent of Participants With Equal of Greater Than 50% Reduction in Mean Nocturic Episodes
时间窗: 12 weeks
Percent of participants with equal of greater than 50% reduction in mean nocturic episodes over the twelve week period
次要结局
未报告次要终点
研究者
研究点 (1)
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