NCT03339726终止2 期
Randomized, Double-blind, Placebo-Controlled Study of the Efficacy of Phenylephrine HCL Extended-Release 30 mg and Phenylephrine HCL Immediate-Release 12 mg Capsules in Subjects With Nasal Congestion Due to the Common Cold
Johnson & Johnson Consumer Inc. (J&JCI)10 个研究点 分布在 1 个国家目标入组 193 人开始时间: 2017年11月30日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 193
- 试验地点
- 10
- 主要终点
- Mean Change From Baseline in the Nasal Congestion Severity Score
研究概览
简要总结
This will be a randomized, double-blind, placebo controlled, parallel-group Phase 2 study to evaluate the efficacy of a new formulation of phenylephrine HCl and a currently marketed phenylephrine HCl for relief of nasal congestion in subjects with naturally occurring cold symptoms.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
New Formulation Phenylephrine HCl
Experimental
干预措施: New Formulation Phenylephrine HCl (Drug)
Marketed Phenylephrine HCl
Active Comparator
干预措施: Marketed Phenylephrine HCl (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Mean Change From Baseline in the Nasal Congestion Severity Score
时间窗: 0-12 hours
Average change from baseline in the Nasal Congestion Severity Score on an 8 point scale with 0=None and 7=Severe. Change from baseline in the Nasal Congestion Severity Score averaged over assessments at 2, 4, 6, 8, 10, and 12 hours.
次要结局
- Average Change From Baseline in the Nasal Congestion Severity Score(0-12 hours)
- Change From Baseline in the Nasal Congestion Severity Score(0-24 hours)
- Average Change From Baseline in Sinus Pressure/Tenderness Scores(0-12 hours)
- Change From Baseline in Sinus Pressure/Tenderness Scores(0-24 hours)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
2 期
Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR MutationCystic FibrosisNCT02589236Nivalis Therapeutics, Inc.138
已完成
2 期
To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic AlopeciaMale Pattern Hair LossAlopeciaNCT05218642Suzhou Kintor Pharmaceutical Inc,123
已完成
2 期
A Study to Evaluate the Impact of MABT5102A on Brain Amyloid Load and Related Biomarkers in Patients With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseNCT01397578Genentech, Inc.91
已完成
2 期
A Study to Evaluate the Efficacy and Safety of MABT5102A in Patients With Mild to Moderate Alzheimer's Disease (ABBY)Alzheimer's DiseaseNCT01343966Genentech, Inc.448
Unknown
2 期
A Phase II, Repeat Single Oral Dose Study of IPED2015 in Healthy Male Subjects With Erectile DysfunctionErectile DysfunctionNCT04969666Initiator Pharma120