Efficacy and Safety of Ibuprofen/Loratadine Fixed-dose Combination Versus the Fixed-dose Administration of Monotherapy as Symptomatic Treatment for Patients With the Common Cold
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- Assess the improvement in symptoms, comparing the percentage change through the Jackson score
研究概览
简要总结
Phase III longitudinal, multicenter, randomized, double-blind clinical trial. The aim of this study is to evaluate the efficacy and safety of the drug combination of Ibuprofen/Loratadine versus Ibuprofen versus Loratadine as monotherapy for the symptomatic treatment of the common cold.
详细描述
Researchers will compare the fixed-dose combination of Ibuprofen + Loratadine versus Ibuprofen versus Loratadine for the symptomatic treatment of the common cold. The adverse events related to the interventions will be registered during follow up.
In the event that the symptoms worsen or the patient's clinical condition warrants the use of any additional medication, the principal investigator or designated physician will be in charge of prescribing it according to the individual clinical condition and the physical examination, this will be recorded as "Concomitant medication".
Participants will:
- Be randomized into one of the 3 intervention groups (A,B,C)
- Visit the clinic at day 0 (day of enrollment) and at day 7
- Answer the first symptomatic related survey at the randomization visit (V0) and the following ones in the morning when they wake up, the last survey will be answered at the final visit (day 7)
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)
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
- •Agree to participate in the study and give written informed consent
- •At least 6 points on the Jackson scale according to physical examination and questioning (sneezing, runny nose, nasal obstruction, sore throat, cough, headache, malaise, and chills).
- •Symptoms associated with the common cold with maximum of 3 days since presentation
- •Women of childbearing potential under a medically acceptable method of contraception
- •At the discretion of the Principal Investigator (PI) or treating physician, treatment with the researching product is indicated and may present clinical benefit
排除标准
- •Patients in whom respiratory symptoms are suspected to be of bacterial origin and generate a clinical picture compatible with: Rhinosinusitis (muco-purulent discharge, headache or facial pain, etc.), lower respiratory tract disease (wheezing, crackles, productive cough, etc.), acute otitis media (otalgia, purulent discharge from the ear, auditory discomfort, etc.).
- •Patients participating in another clinical trial involving an investigational treatment or participation in one within 4 weeks prior to study start
- •Patients in whom participation in the study may be influenced (employment relationship with the research site or sponsor, inmates, etc.)
- •At medical discretion, a disease that affects prognosis and prevents outpatient management, for example, but not limited to: end-stage cancer, kidney, heart, respiratory or liver failure, mental illness or with scheduled surgical or hospital procedures
- •History/presence of any disease or condition that, in the opinion of the Investigator, could pose a risk for the patient or confusing the efficacy and safety of the investigational product
- •Patients in whom the study drug is contraindicated for medical reasons
- •Patients with allergy or hypersensitivity to the active substance of the study drugs, related products or excipients (Ibuprofen of Loratadine)
- •Pregnant women, women breastfeeding or planning a pregnancy during the conducting the study
- •Significant history of gastrointestinal diseases (e.g., gastric ulcer, Crohn's disease, Ulcerative Colitis, etc.)
- •History of chronic liver failure Child-Pugh A, B, and/or C
- •History of acute renal failure (glomerular filtration rate <30 ml/min/1.72 m2)
- •Patients with a history of alcohol or drug abuse in the last year
- •Patients with symptoms suggestive of COVID-19 infection (fever, cough, dyspnea) and/or contact in the last 14 days with a suspected or positive patient for COVID-19
研究组 & 干预措施
Ibuprofen + Loratadine
Administered orally (suspension), 5 mL twice a day, for 7 days.
干预措施: Ibuprofen + Loratadine fixed dose (Drug)
Ibuprofen
Administered orally (suspension), 20 mL, twice a day for 7 days.
干预措施: Ibuprofen (Drug)
Loratadine
Administered orally (suspension), 5 mL, twice a day for 7 days
干预措施: Loratadine (Drug)
结局指标
主要结局
Assess the improvement in symptoms, comparing the percentage change through the Jackson score
时间窗: 7 days
The Jackson score is calculated by summing 8 symptom scores (sneezing, headache, malaise, chilliness, nasal discharge, nasal obstruction, sore throat and cough), rated as 0=absent, 1=mild, 2=moderate, and 3=severe.
Number of participants with treatment-related adverse events through the patient's diary record, by treatment group
时间窗: 7 days
To describe the frequency, intensity and causality of the adverse events presented during the clinical trial by treatment group. The adverse events will be registered by the patient in the diary record. Each adverse event will be followed up at the discretion of the researcher
次要结局
- Assess the subjective change in patients in relation to improvement in symptoms through the Subjective Global Scale(7 days)
- Assess the improvement in health status through the modified Likert Scale(7 days)
- Assess the subjective change in patients in relation to quality of life through the modified Likert score(7 days)