NCT01843842已完成3 期
Multicentre Double-blind Placebo-controlled Parallel-group Randomized Clinical Trial of Safety and Clinical Efficacy of Ergoferon in Liquid Dosage Form in Treatment of Acute Upper Respiratory Tract Infections in Children
Materia Medica Holding11 个研究点 分布在 1 个国家目标入组 306 人开始时间: 2013年4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
- 已完成
- 发起方
- 入组人数
- 306
- 试验地点
- 11
- 主要终点
- Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)
研究概览
简要总结
The purpose of this study is:
- to assess safety of the liquid dosage form of Ergoferon for treatment of acute upper respiratory tract infections in children;
- to assess clinical efficacy of the liquid dosage form of Ergoferon for treatment acute upper respiratory tract infections in children.
详细描述
The overall duration of a patient's participation in the trial is 6 days (screening/randomization, therapy onset - day 1; study therapy period - 5 days; follow-up period-1 day).
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
- 3 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes aged over 3 years and under 18 years.
- •Patients who consulted a doctor within 24 hours after the onset of acute respiratory infection (body temperature no less than 38.0°C when visiting a doctor + intensity of symptoms ≥ 4 scores (presence of at least 1 general symptom ≥ 2 scores and 1 nasal/ throat/ chest symptom ≥ 2 scores or greater number of symptoms with the intensity≥1 score) during seasonal morbidity.
- •The possibility to start therapy within 24 hours after the onset of the first symptoms of acute respiratory infection.
- •Usage of contraceptive methods by sexually active teenagers of both sexes during the trial and within 30 days after ending of the participation in the trial.
- •Availability of information sheet (Informed Consent form) for parents/adopters of patient for participation in the clinical trial, Version 2.1 or Version 2.2, signed by one parent/adopter of patient. For patients over 14 years - availability of information sheet (Informed Consent form) for participation in the clinical trial, Version 2.1 or Version 2.2, signed by a patient and one parent/adopter of patient.
排除标准
- •Suspected bacterial infection or presence of a severe disease requiring use of antibacterial drugs (including sulfanilamides).
- •Suspected initial manifestations of diseases that have symptoms similar to acute respiratory infection (other infectious diseases, influenza-like syndrome at the onset of systemic connective tissue disorders, oncohematology and other pathology).
- •Medical history of primary and secondary immune deficiency: a) lymphoid system immunodeficiency (T-cell and /or B-cell immunity chain, immunodeficiency with predominant antibody deficiency); b) phagocyte deficiency; c) complement factors deficiency; d ) combined immunodeficiency including AIDS induced by HIV infection; toxic, autoimmune, infectious, radial panleukopenia syndrome; general lymphocytopenia syndrome; syndrome of lymphocyte polyclonal activation; postsplenectomia syndrome; congenital asplenia; syndrome of immune complexes pathology associated with infectious, allergic and autoimmune diseases.
- •Medical history of sarcoidosis.
- •Oncological diseases.
- •Exacebration or decompensation of chronic diseases affecting the patient's ability to participate in the clinical trial.
- •Medical history of polyvalent allergy.
- •Allergy/ intolerance to any of the components of medications used in the treatment.
- •Impaired glucose tolerance, diabetes mellitus.
- •Hereditary fructose intolerance (as the study drug contains maltitol).
- •Intake of medicines listed in the section "Prohibited concomitant treatment" for 1 month prior to the inclusion in the trial.
- •Pregnancy, unwillingness of sexually active female patients to use of contraceptive methods during the study.
- •Drug addiction, alcohol usage in the amount 2 units of alcohol per day on the part of patient's parents/adopters.
- •Mental disorders of patient or of patient's parents/adopters.
- •Patient's parents/ adopters, who from investigator's point of 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 3 months prior to the inclusion in the trial.
- •Patient's parent/adopter is related to the research personnel of the investigative site, who are directly involved in the trial or are the immediate relative of the researcher. The immediate relatives includes husband/wife, parents, children or brothers (or sisters), regardless of whether they are natural or adopted.
- •Patient's parent/adopter works for OOO "NPF "Materia Medica Holding" (i.e. is the company's employee, temporary contract worker or appointed official responsible for the carrying out the research) or the immediate relative.
研究组 & 干预措施
Ergoferon (5 ml 3 times a day)
Experimental
干预措施: Ergoferon (Drug)
Placebo (5 ml 3 times a day)
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Patients With Recovery/Improvement in Health on Days 2, 3 and 4 of Observation (Based on Patient Diary Data)
时间窗: On day 2, 3 and 4 of observation
Based on the data mentioned in a patient's diary
次要结局
- Dynamics of Fever (Changes in Body Temperature on 2, 3, 4, 5 Days of Observation in Comparison With the Baseline)(baseline and days 2, 3, 4 and 5 of observation)
- Duration of Acute Respiratory Infection Symptoms (Fever, Non-specific Symptoms and Nasal/ Throat/ Chest Symptoms) Based on Patient Diary Data(baseline and days 2, 3, 4 and 5 of observation)
- Percentage of Patients With Exacerbation of the Disease Course(On days 1-6 of observation)
- Severity of the Disease Within 6 Days Was Assessed Using the "Area Under the Curve" for the Total Symptom Score (TSS)(On days 1-6 of observation)
- Percentage of Patients With Normal Body Temperature (≤37.0ºС)(On day 2, 3, 4, 5 of observation)
- Severity of Clinical Manifestations of Acute Respiratory Infection (ARI) by Total Symptom Score on Day 3 of Observation (Based on the Results of Pediatrician's Examination) and on Days 2, 3, 4 and 5 of Observation (Based on Patient Diary Data)(on Days 2, 3, 4, 5 of Observation)
- Number of Intakes of Antipyretics if Indicated(On day 1, 2, 3, 4 and 5 of the treatment)
研究者
研究点 (11)
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