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RECRUITING
NCT06531707
PHASE3

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

Sponsor: Laboratorios Silanes S.A. de C.V.

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

177

Start Date

2024-05-20

Completion Date

2025-02-20

Last Updated

2024-08-02

Healthy Volunteers

No

Conditions

Interventions

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

Locations (1)

Laboratorio Silanes, S.A. de C.V.

Mexico City, Mexico