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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 3INTERVENTIONAL

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

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 (NCT07626437) is a Phase 3 interventional studying Relief From Common Cold and Flu Symptoms and Nasal Obstruction and/or Congestion Resulting From the Common Cold or Flu in Adult Participants, sponsored by Brainfarma Industria Química e Farmacêutica S/A. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 3 trials confirm efficacy and safety in large patient groups (often 300–3,000+) and form the evidence base for an FDA approval submission. For Relief From Common Cold and Flu Symptoms, Phase 3 studies typically randomize participants between the investigational treatment and either a placebo or current standard of care. A successful Phase 3 result is the threshold most treatments need to clear before regulatory approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

A target enrollment of 620 participants makes this a sizable late-stage trial. Studies in this range typically have enough power to detect clinically meaningful differences from a comparator and to characterize less-common side effects.

Who May Be Eligible (Plain English)

Who May Qualify: - The following criteria must be met for the participant to be included in the study: 1. Participants of both sexes, aged between 18 and 60 years. 2. Be able to understand, agree to participate in the study, comply with procedures, and attend visits, as indicated by signing the willing to sign a consent form form (ICF) approved by the Ethics Committee. 3. 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). 4. Must not have used any medication for symptomatic treatment of the condition. 5. 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. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * The following criteria must be met for the participant to be included in the study: 1. Participants of both sexes, aged between 18 and 60 years. 2. 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. 3. 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). 4. Must not have used any medication for symptomatic treatment of the condition. 5. 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. Exclusion Criteria: * A positive response to any of the following criteria will exclude the participant from the study: 1. Participants with COVID-19, diagnosed by rapid antigen test and/or RT-PCR for SARS-CoV-2; 2. Previous contact with individuals diagnosed with COVID-19 within 14 days prior to screening; 3. Vaccination against influenza and/or COVID-19 within 7 days prior to the study; 4. Presence of gastrointestinal symptoms and/or dyspnea associated with cold or flu symptoms; 5. Clinical history consistent with bacterial upper respiratory tract infection requiring antibiotic therapy; 6. 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; 7. 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; 8. History of hypersensitivity to analgesics, antirheumatic drugs, and/or alcoholic beverages; 9. Participants allergic to foods, hair dyes, and/or preservatives; 10. Participants dependent on decongestants (topical, nasal, or oral) or receiving allergen-specific immunotherapy; 11. 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; 12. 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%). 13. Pregnant or breastfeeding women, or those intending to become pregnant during the study period; 14. Participation in a clinical study within the last 12 months, at the investigator's discretion; 15. Any condition that, in the physician's judgment, may interfere with participation in the study.

Treatments Being Tested

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)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07626437), the sponsor (Brainfarma Industria Química e Farmacêutica S/A), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07626437 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07626437?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07626437?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07626437. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07626437. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-07 · Data from ClinicalTrials.gov.