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

NCT06531707 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 177

Last updated 2024-08-02

No results posted yet for this study

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.

Conditions

  • Common Cold

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

Sponsors & Collaborators

  • Laboratorios Silanes S.A. de C.V.

    lead INDUSTRY

Principal Investigators

  • Ana Luara Flores-Barranco, MD · Oaxaca Site Management Organization

  • Juan A Becerra-Hernández, MD · Centro de Investigación y Avances Médicos Especializados

  • Salvador Perez-Jaime, MD · CIMA

  • Victor C Bohorquez-Lopez, MD · Mérida Investigación Clínica

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2025-01-20
Completion
2025-02-20

Countries

  • Mexico

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06531707 on ClinicalTrials.gov