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RECRUITING
NCT07626437
PHASE3

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

Sponsor: Brainfarma Industria Química e Farmacêutica S/A

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

620

Start Date

2026-05-08

Completion Date

2027-06-30

Last Updated

2026-06-04

Healthy Volunteers

No

Interventions

DRUG

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

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

DRUG

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

The differential of this intervention is the dosages

DRUG

Placebo

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