Phase III Study Comparing Coristina® D to Resfenol® in the Symptomatic Treatment of Common Cold
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 366
- 主要终点
- Global Evaluation from 1 to 3 days after last dose
研究概览
简要总结
The primary objective of this study is to evaluate the non-inferiority of Coristina® d in the symptomatic treatment of the common cold compared to Resfenol® comparator.
详细描述
Eligible patients must sign the informed consent form and they will be between 18 and 60 years old and common cold symptoms for no more than 72 hours.
It will be recruited for this study 366 patients, 183 patients per group. It is estimated that the total number of patients can be recruited in 4 to 6 months from the regulatory approval of the study.
The patient will stay in the study approximately 7 to 10 days (including screening visit / randomization, telephone contact in 3 to 5 days after randomization and final visit from 1 to 3 days after last dose).
Study medication (Coristina d and Resfenol) will be provided by the sponsor and will be appropriately labeled for the clinical study, containing the sponsor information, the trial identification, expiration date, batch and storage conditions
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
- Single (Investigator)
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
- •Sign and date the informed consent form;
- •Age between 18 and 60 years old;
- •Symptoms of common cold not exceeding 72 hours must be present;
- •It will be considered symptoms of the common cold the presence of at least 2 of the 10 symptoms following: runny nose, sneezing, nasal congestion, headache, myalgia, throat discomfort or sore throat, hoarseness, cough or fever. Each of the symptoms listed above will receive a score by Likert scale (no symptom = 0, mild symptoms = 1, moderate symptoms = 2, intense symptoms = 3). The minimum total is 0 and maximum one is 30, which included patients with score higher or equal to 4 points.
排除标准
- •Presence of suggestive symptoms or prior diagnosis requiring regular and continuous treatment of allergic rhinitis or asthma in the last 2 years;
- •Chronic disease of any kind that is contraindicate the participation of the patient based on the opinion of investigator;
- •Hypersensitivity or contraindication to use of components of the study medications;
- •Pregnant or women of childbearing age without adequate contraception;
- •Use of other anti-influenza drugs programmed during the study or for the last 5 days;
- •Regular active smokers (more than 3 cigarettes a day);
- •Participation in another clinical study in less than one year (unless justified benefit by the investigator).
研究组 & 干预措施
Corisitina D
The patient will use the medication 4 times a day - orally The tablets of Coristina® d contain 400 mg acetylsalicylic acid, dexchlorpheniramine 1 mg, 10 mg phenylephrine, and 30 mg of caffeine. Coristina® d is indicated as an analgesic, antipyretic, antiallergic, and nasal congestion for the treatment of the symptoms of influenza and common cold.
干预措施: Coristina d (Drug)
Resfenol
The patient will use the medication 4x / day - orally Resfenol® drug acts against the symptoms of colds and flu, such as nasal congestion, runny nose, fever, headache, muscle pain and other symptoms. The capsules containing 400mg of paracetamol, 4 mg chlorpheniramine and 4mg phenylephrine.
干预措施: Resfenol (Drug)
结局指标
主要结局
Global Evaluation from 1 to 3 days after last dose
时间窗: From 1 to 3 days after the last dose
The primary outcome will be the global evaluation from investigator to be done from 1 to 3 days after the last dose.
次要结局
- Likert Scale for symptons(From the screening until 1 to 3 days after the last dose)
- Adverse Events(From the randomization until 1 to 3 days after the last dose)
- Sleep Questionnaire(From the screening until 1 to 3 days after the last dose)
- Daily Activities(From the screening until 1 to 3 days after the last dose)