NCT01033526已完成4 期
A Two-arm, Multicenter, Randomized, Double-blind, Single Dose Placebo-controlled Parallel Groups Study Evaluating Efficacy and Tolerability of 800 mg Acetylsalicylic Acid (Aspirina® C) in Adult Patients With a Common Cold During a Two Hour in Patient Phase; and a Follow-up Period of Five Days of Home Treatment as Required
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 388
- 主要终点
- Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline
研究概览
简要总结
A two-arm, multicenter, randomized, double-blind, single dose placebo-controlled parallel groups study evaluating efficacy and tolerability of 800 mg Acetylsalicylic Acid (Aspirina C) in adult patients with a common cold during a two hour in patient phase; and a follow-up period of five days of home treatment as required.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Onset of cold symptoms within 48 hours before screening
- •Objective symptoms of common cold
- •Subjective symptoms of common cold
排除标准
- •Pregnancy or lactation period
- •Active peptic ulcer
- •Hemorrhagic diathesis
- •History of chronic or recurrent ulcer disease or history of gastro-intestinal bleeding
- •Hypersensitivity to acetylsalicylic acid, to paracetamol, to any other component of the study medication, to anti-inflammatory or antirheumatic drugs, to other allergens
研究组 & 干预措施
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
Arm 1
Experimental
干预措施: Aspirin (Acetylsalicylic acid, BAYE4465) (Drug)
结局指标
主要结局
Change in Cold Symptoms (patient Wisconsin Upper Respiratory Symptom Survey (WURSS domain 2 score) from baseline
时间窗: 2 hours following intake of the first study medication dose
次要结局
- Changes in Common Cold Profile (sum of WURSS domains 1 182 3)(At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period))
- Changes in Global Cold Severity (WURSS domain 1)(At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period))
- Changes in Cold Symptoms (WURSS domain 2)(At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period))
- Changes in Cold-specific Functional Impairments (WURSS domain 3)(At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period))
- Changes in Global Cold Severity (WURSS domain 4)(At each of five evenings during the follow-up period (or directly prior to the first intake of rescue medication during the follow-up period))
- Adverse Event Collection(Until end of study)
研究者
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