Common Cold/FluPhase 3PANAMANCT07626437
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 3 study testing dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg and dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg in people with Common Cold/Flu and Nasal Congestion, run by Brainfarma Industria Química e Farmacêutica S/A at 15 sites in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Common Cold/Flu, Nasal Congestion, Nasal Obstruction
- What is being tested?
- dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg and dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 620 participants
- Where
- 15 sitesBrazil
- Study dates
- 8 May 2026to 30 Jun 2027
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
Brazil15 sites, 15 recruiting
- Not yet recruiting
Fundação de Beneficência Hospital de Cirurgia
Aracaju, Sergipe, 49055480
Katiane Soares Research Center Manager, 5511970306077, katiane.soares@newdatatrials.com
Raziel O.C. Nunes, Medical Clinic Specialist
- Recruiting
Newdata Clinical Research
Aracaju, Sergipe, 49069021
Katiane Soares Research Center Manager, 5511970306077, katiane.soares@newdatatrials.com
Alex V. C. França, Hepatologist
- Not yet recruiting
Associação Aracajuana Hospital Santa Isabel
Aracaju, Sergipe, 49072720
Katiane Soares Research Center Manager, 5511970306077, katiane.soares@newdatatrials.com
Raziel O.C. Nunes, Medical Clinic Specialist
- Not yet recruiting
Norte Pesquisa Clínica
Belém, Pará, 66093681
Roberta K. Santos, Pulmonology
- Not yet recruiting
Instituto Anima de Extensão Universitária - Unibh
Belo Horizonte, Minas Gerais, 30455610
Luan F. Santos, Pulmonologist
- Not yet recruiting
Husf Hospital Universitário São Francisco Na Providência de Deus
Bragança Paulista, São Paulo, 12916542
Gustavo P. R. Mamprin, Clinical Pathology
- Not yet recruiting
Newdata Clinical Research - Parkmed
Bragança Paulista, São Paulo, 12922160
Katiane Soares Research Center Manager, 5511970306077, katiane.soares@newdatatrials.com
Flávia G. S. B. Melhado, Ophthalmologist
- Not yet recruiting
Apec Sociedade Potiguar de Educação E Cultura
Natal, Rio Grande do Norte, 59076000
Igor T. B. Q. Silva, Infectious disease specialist
- Not yet recruiting
Instituto Anima de Extensão Universitária - Unisul
Palhoça, Santa Catarina, 88137270
Jefferson L. Traebert, Epidemiologist
- Not yet recruiting
Cipes Centro Internacional de Pesquisa Clínica
São José dos Campos, São Paulo, 12230000
Rosemeiry T. M. Melo, Otolaryngologist
- Not yet recruiting
Synvia Clinical
São Paulo, São Paulo, 01139000
Sophia A. Cavicchioli, Medical clinic
- Not yet recruiting
Iscp Sociedade Educacional
São Paulo, São Paulo, 03164000
Rogério S. Lopes, Medical Clinic Specialist
- Not yet recruiting
Rdss Ricardo Diaz Scientific Solution
São Paulo, São Paulo, 04037030
Ricardo S. Diaz, Infectious disease specialist
- Not yet recruiting
A2Z Clinical Centro de Pesquisa Clínica
Valinhos, São Paulo, 13271130
Mauricio W. P. Junior, Pulmonologist
- Not yet recruiting
Centro de Ensino Superior de Vespasiano
Vespasiano, Minas Gerais, 33200664
Fernanda C. Perreiras, General/Surgical Oncologist
About this study
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
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
- Being tested
- dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg, dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg, Placebo
- Keywords
- nasal congestion, flu, cold, dipyrone, dipyrone monohydrate, caffeine, chlorpheniramine maleate, nasal obstruction
- Medical subject headings
- Nasal Obstruction, Influenza, Human, Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mgDrug
The differential of this study is the dosages and reduction of doses per day.
dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mgDrug
The differential of this intervention is the dosages
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg Receives: 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. Receives: Drug: dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg |
| Group C | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start8 May 2026
- Primary completion28 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common Cold/FluStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A multicenter, double-blind, parallel-group study with two treatment groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 620 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/A
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626437
- Sponsor's protocol ID
- HYP007-24
- Acronym
- PANAMA
- Status last verified
- Jun 2026
- First submitted
- 19 May 2026
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No