NCT01119534Unknown3 期
Comparative Efficacy of the Suppository Composed by Guaiacol, Eucalyptol, Menthol and Camphor Versus Guaiacol Suppository Versus Guaifenesin Syrup in Pediatric Patients With Cough Due the Infectious Origin
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Improvement of cough of infectious origin.
研究概览
简要总结
It is believed that the suppository consisting of guaiacol, menthol, camphor and eucalyptol, by their pharmacological properties already established for each component, has the ability to reduce the signs and symptoms related to upper respiratory infections in a manner equivalent (not inferior) to medicine used as a comparator in this study and higher than the suppository containing only guaiacol concentration of 12.5 mg.
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
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients that parents or legal guardians agree to their participation in the study and agree on the terms proposed in the IC, signing it;
- •Patients aged ≥ (greater than or equal to) 02 years and ≤ (less than or equal to) 6 years, 11 months and 29 days, of any ethnicity, class or social group.
- •Patients with acute respiratory disease of upper respiratory viral diseases (URI);
- •Patients with productive cough;
- •Clinical picture of URI defined by the doctor that started less than 48 hours.
排除标准
- •Patients being treated with antibiotics;
- •Presence of clinical features of bacterial infection of the upper airways and / or pulmonary (acute bacterial sinusitis, pneumonia, etc.).
- •Patients with non-productive cough;
- •Treatment with immunosuppressive drugs;
- •Presence of any medical condition that, according to the investigator, should prevent the patient from the study;
- •Participation in clinical trials in the 12 months preceding the study, according to Resolution 251 (ANVISA), August 7, 1997, item III, sub-item J;
- •Patients with serious diseases;
- •Patients who require multidrug treatment;
- •Presence of other concomitant pulmonary diseases
- •History of hypersensitivity to drugs of the same pharmacological classes of substances under investigation;
- •Patients with diseases that interfere with lung function, such as cerebral palsy or muscular atrophies;
- •Patients under medication or supplement (eg physiotherapy) that may interfere with the cough;
- •Patients with severe dysfunction of the hepatorenal function;
- •Patients with x-ray of the chest or sinus compatible with picture of bacterial infection;
- •Patients with blood cell count suggestive of bacterial infection;
- •Changes in laboratory, clinical, physical and / or radiological agents that, judged by investigators, could compromise patient health or reliability of the data.
研究组 & 干预措施
Transpulmin
Experimental
Suppository composed by guaiacol, eucalyptol, menthol and camphor
干预措施: Guaiacol, eucalyptol, menthol and camphor suppository (Drug)
Comparator 1
Active Comparator
Suppository composed by guaiacol
干预措施: guaiacol suppository (Drug)
Comparator 2
Active Comparator
Syrup composed by guaifenesin
干预措施: Guaifenesin syrup (Drug)
结局指标
主要结局
Improvement of cough of infectious origin.
时间窗: 7 days of treatment.
During visits (V1, V2, V3 and V4) will be assessed the signs of improvement of cough of infectious origin.
次要结局
- Analysis of parameters for the improvement of infectious cough.(7 days of treatment.)
研究者
研究点 (1)
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