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 | Recruiting Phase 3

• 1 other identifier: HYP007-24
• Study Type: interventional
• Target: 620
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Common Cold/Flu; Nasal Congestion; Nasal Obstruction

Keywords

nasal congestion; flu; cold; dipyrone; dipyrone monohydrate; caffeine; chlorpheniramine maleate; nasal obstruction

Outcome Measures

Primary Outcomes (1)

• Proportion of participants who show improvement in symptoms of nasal obstruction and/or congestion

  Proportion of participants who show improvement in symptoms of nasal obstruction and/or congestion, obtained through the 4-point Likert scale, 3 days after the start of treatment, compared to baseline, between the experimental drug and the comparator drug. For control purposes, this assessment will also be carried out between the experimental drug arm and the placebo.

  3 days

Study Arms (3)

Group A

EXPERIMENTAL

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

Drug: dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg; Drug: Placebo

Group B

ACTIVE COMPARATOR

dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg, coated tablet.

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

Group C

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

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

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

Group A

Placebo DRUG

Placebo

Group A; Group C

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

The differential of this intervention is the dosages

Group B

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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;

Sponsors & Collaborators

• Brainfarma Industria Química e Farmacêutica S/A: lead

Study Sites (15)

Instituto Anima de Extensão Universitária - Unibh

Belo Horizonte, Minas Gerais, 30455610, Brazil

NOT YET RECRUITING

Centro de Ensino Superior de Vespasiano

Vespasiano, Minas Gerais, 33200664, Brazil

NOT YET RECRUITING

Norte Pesquisa Clínica

Belém, Pará, 66093681, Brazil

NOT YET RECRUITING

Apec Sociedade Potiguar de Educação E Cultura

Natal, Rio Grande do Norte, 59076000, Brazil

NOT YET RECRUITING

Instituto Anima de Extensão Universitária - Unisul

Palhoça, Santa Catarina, 88137270, Brazil

NOT YET RECRUITING

Fundação de Beneficência Hospital de Cirurgia

Aracaju, Sergipe, 49055480, Brazil

NOT YET RECRUITING

Newdata Clinical Research

Aracaju, Sergipe, 49069021, Brazil

RECRUITING

Associação Aracajuana Hospital Santa Isabel

Aracaju, Sergipe, 49072720, Brazil

NOT YET RECRUITING

Husf Hospital Universitário São Francisco Na Providência de Deus

Bragança Paulista, São Paulo, 12916542, Brazil

NOT YET RECRUITING

Newdata Clinical Research - Parkmed

Bragança Paulista, São Paulo, 12922160, Brazil

NOT YET RECRUITING

Cipes Centro Internacional de Pesquisa Clínica

São José dos Campos, São Paulo, 12230000, Brazil

NOT YET RECRUITING

Synvia Clinical

São Paulo, São Paulo, 01139000, Brazil

NOT YET RECRUITING

Iscp Sociedade Educacional

São Paulo, São Paulo, 03164000, Brazil

NOT YET RECRUITING

Rdss Ricardo Diaz Scientific Solution

São Paulo, São Paulo, 04037030, Brazil

NOT YET RECRUITING

A2Z Clinical Centro de Pesquisa Clínica

Valinhos, São Paulo, 13271130, Brazil

NOT YET RECRUITING

MeSH Terms

Conditions

Nasal Obstruction; Influenza, Human; Common Cold

Interventions

Chlorpheniramine; Caffeine

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Airway Obstruction; Respiratory Insufficiency; Respiration Disorders; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Picornaviridae Infections

Intervention Hierarchy (Ancestors)

Pheniramine; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Xanthines; Alkaloids; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Juliana G Augusto

CONTACT

5511976776726; juliana.augusto@brainfarma.ind.br

Juliana A. L. Antonio

CONTACT

5511976776726; juliana.antonio@brainfarma.ind.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multicenter, double-blind, parallel-group study with two treatment groups

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 4, 2026
• Study Start: May 8, 2026
• Primary Completion (Estimated): June 28, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

BR (15)