NCT00937859已完成3 期
A Phase III Randomized, Double Blind, Placebo Control, 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 301 人开始时间: 2009年6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
- 301
- 试验地点
- 1
- 主要终点
- Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night
研究概览
简要总结
The purpose of this study is to evaluate a treatment of nocturia. The hypothesis is that SER120 will decrease the number of nocturic episodes compared to placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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 2 episodes or more per night
排除标准
- •Diabetes Insipidus
- •Renal Insufficiency
- •Hepatic Insufficiency
- •Incontinence
- •Illness requiring steroids
- •Current or past urologic malignancy
- •Nephrotic Syndrome
- •Unexplained pelvic masses
- •Urinary bladder neurological dysfunction
- •Urinary bladder surgery or radiotherapy
- •Sleep Apnea
- •Pregnant or breast feeding
研究组 & 干预措施
SER120
Experimental
SER120
干预措施: SER120 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percent of Participants With at Least 50% Decrease in Mean Nocturic Episodes Per Night
时间窗: 7 weeks
Percent of participants achieving at least 50% reduction in nocturic episodes during the last week of treatment compared to baseline
Change in Mean Number of Nocturic Episodes/Night
时间窗: 7 weeks
Change was calculated as the mean number of nocturic episodes per night during the last week of treatment minus the mean number of nocturic episodes at baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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