A Randomized, Double-blind, Double-dummy, Single-dose, Parallel Group, Multicenter Study to Compare the Antipyretic Efficacy of Acetylsalicy-lic Acid 500 mg and 1,000 mg (2 x 500 mg) and Paracetamol 500 mg and 1,000 mg (2 x 500 mg) With Placebo in Patients With Acute Febrile Upper Respiratory Tract Infections Suspected to be of Viral Origin.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 392
- 主要终点
- Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose.
研究概览
简要总结
This study is addressed to patients suffering from an acute febrile upper respiratory tract infection suspected to be of viral origin. The purpose of this study is to determine the antipyretic efficacy (reduction of fever by lowering the body temperature from a raised state) of Aspirin in doses of 500 and 1000 mg (study medication) compared to the one of Paracetamol in doses of 500 and 1000 mg (comparator medication) as well as the one of Placebo (comparator medication without an active substance). Despite of its common use for fever treatment, the scientific data in adults which support the antipyretic efficacy of Aspirin are sparse. Therefore, the purpose of this study is to collect such data.
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
- Triple (Participant, 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
- •Ambulatory male or female patients 18 to 65 years of age
- •Acute uncomplicated febrile URTI suspected to be of viral origin and present not more than 5 days
- •Symptoms of a viral URTI
- •Oral temperature >/= 38.5 °C to </= 40°C
排除标准
- •Patients with physical findings consistent with the diagnosis of pneumonia, otitis media, bacterial sinusitis or any other bacterial infection of the respiratory tract requiring antibiotics or other therapeutic intervention by a physician
- •Current antibiotic treatment or pre-treatment with antibiotic agents during the last week
- •History or presence of asthma or hypersensitivity to ASA, salicylates, paracetamol, or other non-steroidal anti-inflammatory drugs; peptic ulceration or gastric bleeding; hemorrhagic diathesis; hepatic and/or renal dysfunction; Gilbert's disease; Quincke's edema
- •Any other acute or chronic disease which in the opinion f the investigator could interfere with the patient's health and well-being during the conduct of the study or which could interfere with the evaluation of data generated from this subject
- •Any conditions possibly interfering with the gastro-intestinal absorption of the study medication
- •Pregnant or lactating women. All women of childbearing age were to undergo a pregnancy test before start of the study
研究组 & 干预措施
Arm 2
干预措施: Acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
Arm 3
干预措施: Paracetamol (Drug)
Arm 4
干预措施: Paracetamol (Drug)
Arm 5
干预措施: Placebo (Drug)
Arm 1
干预措施: Acetylsalicylic acid (Aspirin, BAYE4465) (Drug)
结局指标
主要结局
Area under the curve (AUC) of the orally measured change of body temparature from baseline over a period of 0 - 4 hours post dose.
时间窗: Up to 4 hours post dose
次要结局
- Maximum temperature difference between baseline and the lowest measured temperature(Up to 4 hours post dose)
- Time to reach the maximum temperature difference(Up to 4 hours post dose)
- Intensity of Upper Respiratory Tract Infection symptoms(0, 2, 4, and 6 hours post dose)
- Safety - assessment of adverse events(Up to 7 hours post dose)