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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
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.
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)
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Laboratorio Silanes, S.A. de C.V.
Mexico City, Mexico
Start Date
May 20, 2024
Primary Completion Date
January 20, 2025
Completion Date
February 20, 2025
Last Updated
August 2, 2024
177
ESTIMATED participants
Ibuprofen + Loratadine fixed dose
DRUG
Ibuprofen
DRUG
Loratadine
DRUG
Lead Sponsor
Laboratorios Silanes S.A. de C.V.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT01361399