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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
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
Conditions
Interventions
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.
dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg
The differential of this intervention is the dosages
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