NCT01259128已完成3 期
A Phase III Randomized, Open-Label, Multicenter Study to Investigate the Safety and Pharmacokinetics of SER120 Nasal Spray Formulations in Elderly Patients (≥ 75 Years Old) With Nocturia
Serenity Pharmaceuticals, Inc.1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2010年4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
- 32
- 试验地点
- 1
- 主要终点
- Serum Sodium Levels at Baseline and During Treatment
研究概览
简要总结
The purpose of this study is to determine if SER120 nasal spray is well tolerated in 75 years or older nocturic patients.
详细描述
Patients entering the study are randomized to either Level 1 SER120 nasal spray concentration or Level 2 SER120 nasal spray concentration
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
- None
入排标准
- 年龄范围
- 75 Years 至 95 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male & female greater or equal to 75 years of age, history of nocturia
排除标准
- •CHF, Diabetes, Diabetes Insipidus, Renal Insufficiency, Heptatic Insufficiency, Incontinence, Illness requiring steroid, current or past urologic maliganancy, nephrotic syndrome
- •Unexplained pelvic masses
- •Urinary bladder surgery or radiotherapy
- •Sleep apnea
研究组 & 干预措施
SER120 750 ng/day
Experimental
SER120 Level 2 (750 ng/day)
干预措施: SER120 nasal spray 750 ng/day (Drug)
SER120 500 ng/day
Experimental
SER120 Level 1 (500 ng/day)
干预措施: SER120 Nasal Spray 500 ng/day (Drug)
结局指标
主要结局
Serum Sodium Levels at Baseline and During Treatment
时间窗: baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57
Mean serum sodium reported at baseline, Day 4, Day 8, Day 15, Day 22, Day 29, Day 43 and Day 57.
次要结局
- Change in Mean Nocturic Episodes Per Night(Mean value at Week 8 minus mean value at baseline)
- Percent of Participants With Greater or Equal to 50% Reduction in the Number of Nocturic Episodes(8 weeks)
研究者
研究点 (1)
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