Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus L
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.
| Condition(s) | Common Cold |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| 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. |
| Who can participate | 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, |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Laboratorios Silanes S.A. de C.V. |
| Locations | Mexico City, Mexico |
| Start date | 2024-05-20 |
| NCT ID | NCT06531707 |
| Official listing | https://clinicaltrials.gov/study/NCT06531707 |