RecruitingPhase 3NCT07626437

Fixed-dose Combination of 1000 mg Dipyrone Monohydrate + 60 mg Caffeine + 4 mg Chlorpheniramine Maleate in Improving Symptoms of the Common Cold and Flu in Adults

A Phase III, Multicenter, Double-blind, Randomized, Parallel-group Non-inferiority Clinical Trial to Evaluate the Efficacy and Safety of a Fixed-dose Combination of 1000 mg Dipyrone Monohydrate + 60 mg Caffeine + 4 mg Chlorpheniramine Maleate Compared to Benegrip® in Improving Symptoms of the Common Cold and Flu in Adult Participants

Sponsor

Brainfarma Industria Química e Farmacêutica S/A

Enrollment

620 participants

Start Date

May 8, 2026

Study Type

INTERVENTIONAL

Conditions

Nasal congestion Common Cold/Flu nasal obstruction

Summary

Phase III clinical trial to evaluate the efficacy and safety of a fixed-dose combination of 1000 mg dipyrone monohydrate + 60 mg caffeine + 4 mg chlorpheniramine maleate in improving symptoms of the common cold and flu in adults.

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo, a drug called dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg, and others for people with nasal obstruction and/or congestion resulting from the common cold or flu in adult participants and relief from common cold and flu symptoms. The study is currently recruiting participants at 15 locations. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGdipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg

The differential of this study is the dosages and reduction of doses per day.

DRUGdipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg

The differential of this intervention is the dosages

DRUGPlacebo

Placebo

Locations(15)

Instituto Anima de Extensão Universitária - Unibh

Belo Horizonte, Minas Gerais, Brazil

Centro de Ensino Superior de Vespasiano

Vespasiano, Minas Gerais, Brazil

Norte Pesquisa Clínica

Belém, Pará, Brazil

Apec Sociedade Potiguar de Educação E Cultura

Natal, Rio Grande do Norte, Brazil

Instituto Anima de Extensão Universitária - Unisul

Palhoça, Santa Catarina, Brazil

Fundação de Beneficência Hospital de Cirurgia

Aracaju, Sergipe, Brazil

Newdata Clinical Research

Aracaju, Sergipe, Brazil

Associação Aracajuana Hospital Santa Isabel

Aracaju, Sergipe, Brazil

Husf Hospital Universitário São Francisco Na Providência de Deus

Bragança Paulista, São Paulo, Brazil

Newdata Clinical Research - Parkmed

Bragança Paulista, São Paulo, Brazil

Cipes Centro Internacional de Pesquisa Clínica

São José dos Campos, São Paulo, Brazil

Synvia Clinical

São Paulo, São Paulo, Brazil

Iscp Sociedade Educacional

São Paulo, São Paulo, Brazil

Rdss Ricardo Diaz Scientific Solution

São Paulo, São Paulo, Brazil

A2Z Clinical Centro de Pesquisa Clínica

Valinhos, São Paulo, Brazil

View Full Details on ClinicalTrials.gov

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NCT07626437

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