NCT01804946已完成4 期
Multicentre Open Label Comparative Parallel-group Randomized Clinical Trial of Clinical Efficiency and Safety of Ergoferon in Treatment of Influenza
Materia Medica Holding8 个研究点 分布在 1 个国家目标入组 161 人开始时间: 2011年2月最近更新:
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
- 入组人数
- 161
- 试验地点
- 8
- 主要终点
- Percentage of Patients With Normal Body Temperature
研究概览
简要总结
The purpose of this study is:
- to assess clinical efficiency of Ergoferon for treatment of influenza
- to assess safety of Ergoferon for treatment of influenza
- to compare efficiency of Ergoferon and Tamiflu for treatment of influenza
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
- None
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
- •Patients of both sexes aged from 18 to 60 inclusively.
- •Patients with body temperature >37,8°C at the moment of examination by the doctor; with at least one catarrh symptom (cough, rhinitis, sore throat) and one intoxication symptom (myalgia, fever/hyperhidrosis, malaise, weakness, headache) during seasonal influenza morbidity.
- •Diagnosed influenza confirmed by express diagnostics (presence of antigens of influenza virus in nasal passages epithelium and proved by QuickVue immunological test).
- •The possibility to start therapy within 24 hours after the onset of the first influenza symptoms.
- •Signed Informed Consent form for participation in the study.
排除标准
- •Patients aged below 18 years and above 60 years.
- •Suspected invasive bacterial infection or presence of severe disease requiring use of antibacterial drugs (including sulfanilamides).
- •Vaccination against influenza prior to epidemic season onset.
- •Medical history of polyvalent allergy.
- •Allergy/ intolerance to any of the components of medications used in the treatment.
- •Exacerbation or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
- •Chronic renal insufficiency.
- •Intake of medicines listed in the section "Prohibited concomitant treatment" for 15 days prior to the inclusion in the trial.
- •Pregnancy, breast feeding, unwillingness to keeping to contraception method during the study.
- •Drug addiction, alcohol usage in the amount over 2 units of alcohol per day.
- •Patients, who from investigator's point o view, will fail to comply with the observation requirements of the trial or with the intake regimen of the investigated medicines.
- •Participation in other clinical trials in the course of 1 month prior to the inclusion in the trial.
- •The patient is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the reseacher. The immediate relatives includes husband / wife, parents, children, brothers (or sisters), regardless of whether they are natural or adopted.
- •The patient works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or designated official responsible for carrying out the research) or the immediate relative.
研究组 & 干预措施
Ergoferon (1 tablet 3 times a day)
Experimental
1 tablet per 1 intake: on day 1 of the treatment 8 tablets (1 tablet every 30 minutes for the first 2 hours, then 1 tablet 3 times a day with equal intervals starting on the same day. From day 2 to day 5 1 tablet TID.
干预措施: Ergoferon (Drug)
Oseltamivir(Tamiflu): 75 mg two times a day.
Active Comparator
Oseltamivir for 5 days (75 mg b.i.d.).
干预措施: Oseltamivir (Drug)
结局指标
主要结局
Percentage of Patients With Normal Body Temperature
时间窗: Day 1 to Day 5
Axillary temperature (morning and evening) decline to or below 37.0 ºС (without subsequent increase during ≥24 h)
次要结局
- Severity of Influenza Symptoms (Total Score of the Common Symptoms and Respiratory Symptoms)(on days 1, 3 and 7 of the observation)
- Percentage of Patients With Resolution of Influenza Symptoms(on the day 7 of the observation)
- Time to Resolution of the Influenza(Day 1 to Day 7)
- Mean Body Temperature(on days 1, 3 and 7 of the observation)
- The Number of the Antipyretic Intake(Day 1 to Day 5)
- Change in the Patient's Quality of Life.(Day 7 vs. Day 1)
- Change in the Subjective Health Status(Day 7 vs. Day 1)
- Percentage of Patients With Complications of the Influenza(Day 1 to Day 7)
研究者
研究点 (8)
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