A Multicenter, Randomized, Parallel-group, Double-blind, Comparative Trial of the Superiority of Paracetamol 500mg/Fexofenadine 60mg/Phenylephrine 20mg Fixed-dose Combination Versus Placebo in the Symptomatic Treatment of Flu and Cold
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 567
- 试验地点
- 2
- 主要终点
- Relief of cold and flu symptoms
研究概览
简要总结
A Phase 3, multicenter, Randomized, Double-blind, comparative clinical trial to evaluate the association of paracetamol 500mg + Fexofenadine 60mg + Phenylephrine 20mg in the flu and common cold treatment.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
详细描述
A multicenter, randomized, double-blind, parallel-group, superiority, placebo control clinical trial.
Adult patients (aged ≥ 18 years) of both sexes with common cold or flu will be randomized in a 1:1 ratio to receive the experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg) or placebo, in the dosage of one (01) film-coated tablet every eight (08) hours, for 3 to 7 days.
The primary superiority assessment will be carry out compared the experimental drug to placebo in the relief of cold and flu symptoms through the absolute variation of the overall score obtained in the symptom assessment questionnaire after treatment start.
⚠️Study will only be conducted in research centers in Brazil (please do not send e-mail if your center is outside brazil).
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
- Double (Participant, Investigator)
盲法说明
Group 1: Eurofarma Laboratórios SA paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg FDC (experimental drug).
Group 2: Placebo.
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
- •Common cold: presence of moderate to severe nasal congestion AND moderate to severe runny nose AND at least one (01) of the following moderate to severe symptoms: sneezing, headache, myalgia, sore throat, throat pain, dysphonia, cough and fever.
- •Duration of symptoms ≤ 48 hours at screening. Informed Consent Form (ICF) signed before carrying out any study procedure.
排除标准
- •Presence of significant septum deviation, compatible with impaired nasal ventilatory function, at the investigator's discretion.
- •Presence of nasal polyposis to previous rhinoscopy.
- •Known hypersensitivity to any component of the experimental drug formulation.
- •Required antibiotic therapy for upper airway infection treatment
研究组 & 干预措施
Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg)
Group 1: paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg FDC (experimental drug).
干预措施: Experimental drug (paracetamol 500mg / fexofenadine 60mg / phenylephrine 20mg) (Drug)
Placebo group
Group 2: Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Relief of cold and flu symptoms
时间窗: 26 hours
absolute variation of the overall score obtained in the symptom assessment questionnaire (Likert Scale), in which nasal congestion, runny nose, sneezing, headache, myalgia, sore throat, throat pain hoarseness, cough and fever will be assessed on a 4-point categorical scale (0 = absent, 1 = mild, 2 = moderate and 3 = severe) after administration of the first dose of the study treatment from baseline. The overall symptom score will be determined by the sum of the points assigned to the individual symptoms. The baseline overall score will vary in the interval of 6 to 30 points, ranging from 0 to 30 points in the other assessments, and the higher the score, the worse the subject's symptoms
次要结局
- overall efficacy of the experimental drug(11 days)
- efficacy of the experimental drug on the nasal congestion symptoms(3 hours (± 30 minutes), 26 (± 2) hours and 3 (± 1) days after administration)
- duration of the experimental drug treatment(7 days)
- use of rescue medication(7 days)