NCT01357356已完成2 期
A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Study to Investigate the Efficacy and Safety of SER120 Nasal Spray Formulations in Patients With Nocturia
Serenity Pharmaceuticals, Inc.1 个研究点 分布在 1 个国家目标入组 750 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 750
- 试验地点
- 1
- 主要终点
- Change in # of Mean Nocturic Episodes Per Night
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of SER120 nasal spray formulations in patients with nocturia for a total duration of 14 weeks.
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
- 50 Years 至 —（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 episode per night
排除标准
- •Diabetis Insipidus
- •Renal Insufficiency
- •Hepatic Insufficiency
- •Incontinence
- •Illness 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/day)
Experimental
SER120 (750 ng/day)
干预措施: SER120 (750 ng/day) (Drug)
SER120 (1000 ng/day)
Experimental
SER120 (1000 ng/day)
干预措施: SER120 (1000 ng/day) (Drug)
SER120 (1500 ng/day)
Experimental
SER120 (1500 ng/day)
干预措施: SER120 (1500 ng/day) (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in # of Mean Nocturic Episodes Per Night
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 50% or Greater in Reduction of Nocturic Episodes
时间窗: 12 weeks
Percent of participants achieving at least 50% reduction in mean nocturic episode per night during 12 weeks compared to baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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