Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine
NCT Number: NCT06531707
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE3
Conditions: Common Cold
Interventions: DRUG: Ibuprofen + Loratadine fixed dose|DRUG: Ibuprofen|DRUG: Loratadine
Sponsor: Laboratorios Silanes S.A. de C.V.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 177
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-20
Completion Date: 2025-02-20
Locations: Laboratorio Silanes, S.A. de C.V., Mexico City, 11000, Mexico

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.

Primary Outcome Measures: Assess the improvement in symptoms, comparing the percentage change through the Jackson score, 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., 7 days|Number of participants with treatment-related adverse events through the patient's diary record, by treatment group, 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, 7 days
Secondary Outcome Measures: Assess the subjective change in patients in relation to quality of life through the modified Likert score, 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., 7 days|Assess the subjective change in patients in relation to improvement in symptoms through the Subjective Global Scale, 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., 7 days|Assess the improvement in health status through the modified Likert Scale, 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., 7 days
Other Outcome Measures: Assess the percentage of patients with febrile episodes (≥38°C) during the intervention, The patient will report the presence of fever during the intervention, quantified with a thermometer., 7 days|To report the percentage of therapeutic adherence at day 7 of intervention by group of treatment, 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, 7 days