Double Blind, Randomized, Placebo Controlled Study of Mucinex® for the Treatment of Symptoms of an Acute Respiratory Tract Infection When Two 600 mg Tablets Are Given Every 12 Hours for 7 Days
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- Investigator's End of Study Assessment of Treatment
研究概览
简要总结
This is an exploratory, multicenter, randomized, blinded, placebo-controlled study of Mucinex in patients with colds. Patients will receive 7 days of treatment with either Mucinex or placebo. The study will assess the effects of Mucinex on sputum and 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •common cold symptoms
- •meet symptom severity
- •females of child-bearing potential must have negative pregnancy test and use effective birth control
排除标准
- •chronic respiratory conditions
- •significant heart, kidney, liver, or lung disease, uncontrolled hypertension or diabetes, cystic fibrosis, thyroid disorder
- •pregnant or lactating
- •known malignancy
- •participation in any other clinical trial within 30 days of baseline
- •related to another enrolled patient or persons involved directly or indirectly with the conduct of this study
研究组 & 干预措施
Mucinex
干预措施: guaifenesin (Mucinex) (Drug)
placebo
干预措施: placebo (Drug)
结局指标
主要结局
Investigator's End of Study Assessment of Treatment
时间窗: 7 days
Yes the investigator would use this treatment for cold symptoms in the future.
Mean Change From Baseline in a 6 Point Severity Scale (0 = None, 1 = Very Mild, 2 = Mild or Slight, 3 = Moderate, 4 = Severe or 5 = As Bad as it Can be) for Cough.
时间窗: Baseline and Day 4
Mean change from baseline in a 6 point severity scale between treatment groups(0 = None, 1 = Very mild, 2 = Mild or slight, 3 = Moderate, 4 = Severe or 5 = As bad as it can be) for cough.
次要结局
- Number of Patients With Adverse Events(7 days)