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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Common Cold/Flu, Nasal Congestion, Nasal Obstruction

In brief

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.

Key facts

Study ID

NCT07626437

Run by

Brainfarma Industria Química e Farmacêutica S/A

People needed

620

Starts

2026-05-08

Expected to finish

2027-06-30

Last updated by the study team

2026-06-16

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• The following criteria must be met for the participant to be included in the study:
• Participants of both sexes, aged between 18 and 60 years.
• Be able to understand, agree to participate in the study, comply with procedures, and attend visits, as indicated by signing the informed consent form (ICF) approved by the Ethics Committee.
• Present symptoms of nasal obstruction and/or congestion due to the common cold or influenza, with onset within less than 48 hours, with symptoms classified by the participant as moderate to severe on a 4-point scale (0 = no symptoms; 1 = mild symptoms; 2 = moderate symptoms; 3 = severe symptoms).
• Must not have used any medication for symptomatic treatment of the condition.
• Female participants without childbearing potential, defined as postmenopausal women (defined as 12 months or more of amenorrhea) or those who have undergone surgical sterilization*, OR female participants with reproductive potential who agree to use a reliable contraceptive method**.
• Female sterilization (bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation performed at least 6 weeks before administration of the investigational product.
• * If the participant is of childbearing potential and decides to participate in the study, she must use or request that her partner use a reliable contraceptive method. Reliable contraception is defined as the use of at least one of the following: condoms, diaphragm, and/or hormonal contraceptive methods (estrogenic and/or progestogenic), including oral, vaginal, injectable, transdermal, implantable, and intrauterine devices. Only participants who explicitly declare no risk of pregnancy, either due to not engaging in sexual activity or engaging exclusively in non-reproductive practices, may participate without mandatory contraceptive use; for example: participants with a sterile or vasectomized partner (at least 6 months before screening), or total heterosexual abstinence.

You may not qualify if…

• A positive response to any of the following criteria will exclude the participant from the study:
• Participants with COVID-19, diagnosed by rapid antigen test and/or RT-PCR for SARS-CoV-2;
• Previous contact with individuals diagnosed with COVID-19 within 14 days prior to screening;
• Vaccination against influenza and/or COVID-19 within 7 days prior to the study;
• Presence of gastrointestinal symptoms and/or dyspnea associated with cold or flu symptoms;
• Clinical history consistent with bacterial upper respiratory tract infection requiring antibiotic therapy;
• History of grade II or III septal deviation, nasal polyps, marked turbinate hypertrophy, adenoid hypertrophy, chronic sinusitis (or recent episode within the last 2 weeks), rhinitis (seasonal allergic, drug-induced, vasomotor, atrophic, or other), or other conditions causing nasal obstruction;
• Diagnosis of: congenital glucose-6-phosphate dehydrogenase deficiency, prothrombin deficiency, gastroduodenal ulcer, hepatic porphyria, narrow-angle glaucoma, chronic nephritis, blood dyscrasias, asthma, chronic respiratory infection, chronic respiratory disease, severe cardiocirculatory conditions, or immunocompromised status;
• History of hypersensitivity to analgesics, antirheumatic drugs, and/or alcoholic beverages;
• Participants allergic to foods, hair dyes, and/or preservatives;
• Participants dependent on decongestants (topical, nasal, or oral) or receiving allergen-specific immunotherapy;
• Use of monoamine oxidase inhibitors (phenelzine, iproniazid, isocarboxazid, harmaline, nialamide, pargyline, selegiline, toloxatone, tranylcypromine, moclobemide), cyclosporine, chlorpromazine, barbiturates (phenobarbital, thiopental, methohexital, pentobarbital), hypnotics (triazolam, midazolam, oxazepam, chlordiazepoxide, clonazepam), narcotic analgesics (morphine, codeine, meperidine), sedatives, and/or tranquilizers;
• History of alcoholism (average alcohol intake exceeding 3 standard drinks* in a single day or more than 7 drinks per week for women, and more than 4 drinks in a single day or more than 14 drinks per week for men);
• One standard drink is defined as: one can of regular beer (330 mL at 4%); one serving of distilled spirits (30 mL at 40%); one glass of wine or small glass of sherry (100 mL at 12% or 70 mL at 18%); one small glass of liqueur or similar (50 mL at 25%).
• Pregnant or breastfeeding women, or those intending to become pregnant during the study period;
• Participation in a clinical study within the last 12 months, at the investigator's discretion;
• Any condition that, in the physician's judgment, may interfere with participation in the study.

Where it is running

• Newdata Clinical Research — Aracaju, Sergipe, Brazil (enrolling)
• 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
• 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
• Instituto Anima de Extensão Universitária - Unibh — Belo Horizonte, Minas Gerais, Brazil
• A2Z Clinical Centro de Pesquisa Clínica — Valinhos, São Paulo, Brazil

Full record on ClinicalTrials.gov

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