NCT02656914撤回3 期
Phase III, National, Multicenter, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy and Safety of Irlanda-2 Association on the Treatment of Common Cold
EMS1 个研究点 分布在 1 个国家开始时间: 2019年6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
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Determine efficacy of Irlanda-2-Association in the treatment of common cold symptoms.
研究概览
简要总结
The purpose of this study is to evaluate the clinical efficacy of the drug associations in the treatment of common cold
详细描述
Double blind,randomized, multicenter; Maximal experiment duration: 7 days; 03 visits; Safety and efficacy evaluation
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)
盲法说明
Double blind study
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant within 48 hours of the onset of common cold symptoms: headache, sneezing, sore throat, nasal obstruction, cough, coryza and body pain;
- •Signed consent.
排除标准
- •Patients with any clinically significant disease that, in the investigator opinion, can´t participate in the study;
- •Patients with any laboratory finding or image finding that, in the investigator opinion, can´t participate in the clinical trial;
- •Patients with history of hypersensitivity to any of the formula compounds;
- •Participation in clinical trial in the year prior to this study;
- •Patients with vaccine reaction;
- •Patients who have uncontrolled asthma. However, participants in use of pulmonary corticosteroids (alone or in combination with other products) will be allowed if they are in stable dose and diagnosed with controlled asthma;
- •Patients with gastroesophageal reflux, gastric or duodenal ulcer or other serious disease of the gastrointestinal tract;
- •Patients with diabetes mellitus type I and II;
- •Pregnancy or risk of pregnancy and lactating patients;
- •Patients in use of drugs that can interfere with flu symptoms evaluation.
研究组 & 干预措施
Irlanda-2-Association
Experimental
Take 10 mL every 12 hours (2x/day), oral route.
干预措施: Irlanda-2-Association (Drug)
Placebo
Placebo Comparator
Take 10 mL every 12 hours (2x/day), oral route.
干预措施: Placebo (Drug)
结局指标
主要结局
Determine efficacy of Irlanda-2-Association in the treatment of common cold symptoms.
时间窗: 7 days
次要结局
- Safety will be evaluated by the adverse events occurrences(7 days)
研究者
研究点 (1)
Loading locations...
相似试验
撤回
3 期
Efficacy and Safety of Irlanda-1-Association on the Treatment of Common Cold in ChildrenCommon ColdNCT02656888EMS
已完成
2 期
Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal CancerBRAF V600E-mutant Metastatic Colorectal CancerNCT03693170Pierre Fabre Medicament95
已完成
3 期
Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine and Caffeine in Osteomuscular TreatmentMusculoskeletal PainNCT02862977EMS414
已完成
3 期
Efficacy and Safety of the Combination of Ketoprofen and Cyclobenzaprine in Osteomuscular TreatmentMusculoskeletal PainNCT03025113EMS416
已完成
1 期
Vericiguat Drug-drug Interaction Study With Isosorbite Mononitrate in Stable Coronary Artery Disease PatientsCoronary Artery DiseaseNCT03255512Bayer41