NCT06531707

Efficacy and Safety in the Combination of Ibuprofen / Loratadine Versus Ibuprofen Versus Loratadine

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 177 (estimated)
• Sponsor: Laboratorios Silanes S.A. de C.V. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Common Cold

Interventions

Type	Name	Description
DRUG	Ibuprofen + Loratadine fixed dose	Suspension 8,000 mg / 100 mg / 100 mL, 5 mL twice a day
DRUG	Ibuprofen	Suspension 2,000 mg / 100 mL, 20 mL twice a day
DRUG	Loratadine	Suspension 1 mg / 1 mL, 5 mL twice a day

Timeline

• Start date: 2024-05-20
• Primary completion: 2025-01-20
• Completion: 2025-02-20
• First posted: 2024-08-01
• Last updated: 2024-08-02

Locations

1 site across 1 country: Mexico