Common Cold
Conditions
Keywords
Common Cold, Flu, Ibuprofen, Loratadine
Brief summary
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.
Detailed description
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)
Interventions
DRUGIbuprofen + Loratadine fixed dose
Suspension 8,000 mg / 100 mg / 100 mL, 5 mL twice a day
DRUGIbuprofen
Suspension 2,000 mg / 100 mL, 20 mL twice a day
DRUGLoratadine
Suspension 1 mg / 1 mL, 5 mL twice a day
Sponsors
Laboratorios Silanes S.A. de C.V.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the improvement in symptoms, comparing the percentage change through the Jackson score | 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assess the improvement in health status through the modified Likert Scale | 7 days | To compare improvement in health status as a difference in the modified Likert scale by treatment group during the 7 days after starting treatment with respect to the baseline measurement.The patient will answer the scale daily. The Likert Scale is a seven point scale that is used to allow an individual to express how much they agree or disagree with a particular statement. The scale consists of 1 question associated to the health status of the patient. The possible answers go from Not feeling sick to feeling to Severely sick. |
| Assess the subjective change in patients in relation to improvement in symptoms through the Subjective Global Scale | 7 days | Assess the improvement in symptoms measured as the proportion of patients who present a change in the Global Subjective Scale during the 7 days after starting treatment with respect to the baseline measurement. The subjective global scale for symptom improvement compares with the score of the previous day to determine health status daily. Is consists of 1 question related to the progress in the symptoms presentation, the answers go from much better to really worse. |
| Assess the subjective change in patients in relation to quality of life through the modified Likert score | 7 days | To compare quality of life measured as a difference in the modified Likert score by treatment group during the 7 days after starting treatment with respect to the baseline measurement. The patient will answer the scale daily. The Likert Scale is a seven point scale that is used to allow an individual to express how much they agree or disagree with a particular statement. The scale consists of 1 question associated to quality of life. The possible answers go from No interference to Severe interference. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Assess the percentage of patients with febrile episodes (≥38°C) during the intervention | 7 days | The patient will report the presence of fever during the intervention, quantified with a thermometer. |
| To report the percentage of therapeutic adherence at day 7 of intervention by group of treatment | 7 days | Adherence to treatment will be defined as a consumption ≥ 80% of the doses that the patient should have ingested at the time of the corresponding evaluation |
Countries
Mexico
Contacts
Primary ContactJorge A Gonzalez, PhD
Backup ContactYulia Romero-Antonio, B.S.
Outcome results
None listed