NCT00441246已完成4 期
A Randomized, Double-Blind, Parallel-Group, Multicenter, Placebo-Controlled Study of the Safety and Efficacy of Mucinex D as Adjunct Therapy to Antibiotic Treatment of Acute Respiratory Infection
Adams Respiratory Therapeutics56 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2007年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 56
- 主要终点
- The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection.
研究概览
简要总结
The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages Eligible for Study: 18 to 75 years,
- •Genders Eligible for Study: Both
- •Adult patients presenting at the physician's office with symptoms diagnostic for acute respiratory infection, such as bronchitis or rhinosinusitis; with a clinical diagnosis of acute respiratory infection, meeting the physician's usual diagnostic criteria in practice for prescription of oral antibiotics.
- •The investigator will evaluate patients on a total of seven criteria for inclusion.
排除标准
- •Have chronic, recurring respiratory signs and symptoms, such as allergic rhinitis or chronic bronchitis, which, in the investigator's opinion, would confound interpretation of symptoms ratings for the acute respiratory infection;
- •The Investigator will evaluate patients on twelve additional criteria for exclusion.
结局指标
主要结局
The objective of the study is to evaluate the safety and efficacy of Mucinex D tablets in providing symptom relief when administered as an adjunct to antibiotic therapy in patients with acute respiratory infection.
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (56)
Loading locations...
相似试验
已完成
4 期
Safety and Efficacy Study of Guaifenesin and Pseudoephedrine for Symptomatic Therapy to Treat Acute RTIAcute Upper Respiratory Track InfectionNCT01202279Reckitt Benckiser Inc.1,179
已完成
1 期
A Multiple Ascending Dose Study With LY03003 in Patients With Early-stage Parkinson's DiseaseParkinson DiseaseNCT04045678Luye Pharma Group Ltd.30
终止
2 期
A Safety & Efficacy Study of BGS649 in Women With Refractory EndometriosisPelvic Pain Associated With Refractory EndometriosisNCT01116440Mereo BioPharma27
已完成
1 期
A Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of E2027 in Healthy SubjectsHealthy SubjectsNCT02873156Eisai Inc.74
已完成
1 期
Evaluating the Effect of Mucinex® 1200 mg on Mucociliary and Cough Clearance From the Human LungMucociliary ClearanceNCT00902707University of North Carolina, Chapel Hill12