NCT00981682已完成3 期
A Phase III Open-Label Extension Study to Investigate the Safety of SER120 Nasal Spray Formulations in Patients With Nocturia Completing Study SPC-SER120-DB1-200901 or Study SPC-SER120-DB2-200902
Serenity Pharmaceuticals, Inc.1 个研究点 分布在 1 个国家目标入组 376 人开始时间: 2009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
- 376
- 试验地点
- 1
- 主要终点
- Mean Serum Sodium
研究概览
简要总结
The hypothesis of this study is that SER120 is safe and well tolerated for use in nocturic patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients completed SPC-SER120-DB1-200901 and SPC-SER120-DB2-200902 studies
- •Willing to provide consent for the study
排除标准
- •Incontinence
- •Diabetes Insipidus, Diabetes Mellitus
- •Renal Insufficiency
- •Significant medical history which make participation unacceptable
研究组 & 干预措施
SER120 (desmopressin)
Experimental
干预措施: SER120 (Drug)
结局指标
主要结局
Mean Serum Sodium
时间窗: 40 weeks
Change in mean serum sodium on Day 8, Day 15, Day 22, Week 4, Week 8, Week 12, Week 20, Week 28 and Week 40 compared to Baseline
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Study for Participants With Spinal Muscular Atrophy (SMA) Who Previously Participated in Nusinersen (ISIS 396443) Investigational StudiesSpinal Muscular AtrophyNCT02594124Biogen292
Enrolling By Invitation
3 期
Long-term Efficacy and Safety of OLE LIB003 in HoFH, HeFH, and High-risk CVD Patients Requiring Further LDL-C ReductionCardiovascular Disease With Mention of ArteriosclerosisElevated CholesterolFamilial HypercholesterolemiaNCT04798430LIB Therapeutics LLC2,000
已完成
2 期
An Open Label Phase 2 Extension Study of Higher Dose Sialic Acid-Extended Release (SA-ER) Tablets and Sialic Acid-Immediate Release (SA-IR) Capsules in Patients With Glucosamine (UDP-N-acetyl)-2-Epimerase (GNE) MyopathyGNE MyopathyHereditary Inclusion Body Myopathy (HIBM)NCT01830972Ultragenyx Pharmaceutical Inc59
已完成
3 期
CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary AngioedemaHereditary Angioedema (HAE)NCT05819775CSL Behring22
进行中（未招募）
3 期
Study Of Comparing SAF-189s With Crizotinib In First Line ALK-Positive Advanced and Metastatic NSCLCALK-positiveSAF-189sNon-Small Cell Lung CancerNCT06569420Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd.275