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 (PANAMA)

June 2, 2026 updated by: Brainfarma Industria Química e Farmacêutica S/A

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

620

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Brazil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30455610
        • Not yet recruiting
        • Instituto Anima de Extensão Universitária - Unibh
        • Principal Investigator:
          • Luan F. Santos, Pulmonologist
      • Vespasiano, Minas Gerais, Brazil, 33200664
        • Not yet recruiting
        • Centro de Ensino Superior de Vespasiano
        • Principal Investigator:
          • Fernanda C. Perreiras, General/Surgical Oncologist
    • Pará
      • Belém, Pará, Brazil, 66093681
        • Not yet recruiting
        • Norte Pesquisa Clínica
        • Principal Investigator:
          • Roberta K. Santos, Pulmonology
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brazil, 59076000
        • Not yet recruiting
        • Apec Sociedade Potiguar de Educação E Cultura
        • Principal Investigator:
          • Igor T. B. Q. Silva, Infectious disease specialist
    • Santa Catarina
      • Palhoça, Santa Catarina, Brazil, 88137270
        • Not yet recruiting
        • Instituto Anima de Extensão Universitária - Unisul
        • Principal Investigator:
          • Jefferson L. Traebert, Epidemiologist
    • Sergipe
      • Aracaju, Sergipe, Brazil, 49055480
        • Not yet recruiting
        • Fundação de Beneficência Hospital de Cirurgia
        • Contact:
        • Principal Investigator:
          • Alex V. C. França, Hepatologist
        • Sub-Investigator:
          • Raziel O.C. Nunes, Medical Clinic Specialist
      • Aracaju, Sergipe, Brazil, 49069021
        • Recruiting
        • Newdata Clinical Research
        • Contact:
        • Principal Investigator:
          • Alex V. C. França, Hepatologist
        • Sub-Investigator:
          • Raziel O. C. Nunes, Medical Clinic Specialist
      • Aracaju, Sergipe, Brazil, 49072720
        • Not yet recruiting
        • Associação Aracajuana Hospital Santa Isabel
        • Contact:
        • Principal Investigator:
          • Alex V. C. França, Hepatologist
        • Sub-Investigator:
          • Raziel O.C. Nunes, Medical Clinic Specialist
    • São Paulo
      • Bragança Paulista, São Paulo, Brazil, 12916542
        • Not yet recruiting
        • Husf Hospital Universitário São Francisco Na Providência de Deus
        • Principal Investigator:
          • Gustavo P. R. Mamprin, Clinical Pathology
      • Bragança Paulista, São Paulo, Brazil, 12922160
        • Not yet recruiting
        • Newdata Clinical Research - Parkmed
        • Contact:
        • Principal Investigator:
          • Flávia G. S. B. Melhado, Ophthalmologist
      • São José dos Campos, São Paulo, Brazil, 12230000
        • Not yet recruiting
        • Cipes Centro Internacional de Pesquisa Clínica
        • Principal Investigator:
          • Rosemeiry T. M. Melo, Otolaryngologist
      • São Paulo, São Paulo, Brazil, 01139000
        • Not yet recruiting
        • Synvia Clinical
        • Principal Investigator:
          • Sophia A. Cavicchioli, Medical clinic
      • São Paulo, São Paulo, Brazil, 03164000
        • Not yet recruiting
        • Iscp Sociedade Educacional
        • Principal Investigator:
          • Rogério S. Lopes, Medical Clinic Specialist
      • São Paulo, São Paulo, Brazil, 04037030
        • Not yet recruiting
        • Rdss Ricardo Diaz Scientific Solution
        • Principal Investigator:
          • Ricardo S. Diaz, Infectious disease specialist
      • Valinhos, São Paulo, Brazil, 13271130
        • Not yet recruiting
        • A2Z Clinical Centro de Pesquisa Clínica
        • Principal Investigator:
          • Mauricio W. P. Junior, Pulmonologist

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Group C
Placebo
Drug: Placebo
Placebo
Experimental: Group A
dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg
Drug: Placebo
Placebo
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.
Active Comparator: Group B
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
The differential of this intervention is the dosages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants who show improvement in symptoms of nasal obstruction and/or congestion
Time Frame: 3 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brainfarma Industria Química e Farmacêutica S/A

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 8, 2026

Primary Completion (Estimated)

June 28, 2027

Study Completion (Estimated)

June 30, 2027

Study Registration Dates

First Submitted

May 19, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 4, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYP007-24

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Relief From Common Cold and Flu Symptoms

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Philippines

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe