NCT01465009已完成4 期
Double-blind, Randomized, Placebo-controlled, Single Dose, Parallel Group Study Evaluating Efficacy and Safety of 1000 mg Acetylsalicylic Acid and 1000 mg Paracetamol in Adult Patients With Sore Throat Associated With a Common Cold
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
- 508
- 主要终点
- Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of 1000 mg Aspirin (study medication) by comparing 1000 mg Paracetamol (study medication) in treating the symptoms of sore throat associated with a common cold. The study is designed to develop a treatment method against sore throat associated with a common cold which will have more advantages for patients than the methods that are currently available.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients
- •Onset of common cold within the past 5 days
- •Current sore throat
- •Confirmed presence of a tonsillo-pharyngitis
排除标准
- •Hypersensitivity to acetylsalicylic acid, salicylates, paracetamol, or any other NSAID
- •Pregnant or lactating women
- •History or acute state of peptic ulceration or gastrointestinal bleeding
- •History of bleeding tendency
- •History of asthma
- •Inability to breathe through the nose or a history of chronic mouth breathing
- •Other exclusion criteria may apply
研究组 & 干预措施
Arm 1
Experimental
干预措施: Acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Arm 2
Active Comparator
干预措施: Paracetamol (Drug)
Arm 3
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Paracetamol
时间窗: For 6 hours after drug intake
次要结局
- Total pain relief of Acetylsalicylic Acid in comparison to Paracetamol(For 6 hours after drug intake)
- Total pain relief of Acetylsalicylic Acid in comparison to Placebo(For 6 hours after drug intake)
- Adverse Event collection(Up to 17 days after Screening)
- Evaluation of Upper Respiratory Tract Infection symtoms(2 hours after drug intake)
- Pain intensity difference to baseline of Acetylsalicylic Acid in comparison to Placebo(For 6 hours after drug intake)
研究者
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