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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)

15 de junio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

620

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Brasil
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasil, 30455610
        • Aún no reclutando
        • Instituto Anima de Extensão Universitária - Unibh
        • Investigador principal:
          • Luan F. Santos, Pulmonologist
      • Vespasiano, Minas Gerais, Brasil, 33200664
        • Aún no reclutando
        • Centro de Ensino Superior de Vespasiano
        • Investigador principal:
          • Fernanda C. Perreiras, General/Surgical Oncologist
    • Pará
      • Belém, Pará, Brasil, 66093681
        • Aún no reclutando
        • Norte Pesquisa Clínica
        • Investigador principal:
          • Roberta K. Santos, Pulmonology
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brasil, 59076000
        • Aún no reclutando
        • Apec Sociedade Potiguar de Educação E Cultura
        • Investigador principal:
          • Igor T. B. Q. Silva, Infectious disease specialist
    • Santa Catarina
      • Palhoça, Santa Catarina, Brasil, 88137270
        • Aún no reclutando
        • Instituto Anima de Extensão Universitária - Unisul
        • Investigador principal:
          • Jefferson L. Traebert, Epidemiologist
    • Sergipe
      • Aracaju, Sergipe, Brasil, 49055480
        • Aún no reclutando
        • Fundação de Beneficência Hospital de Cirurgia
        • Contacto:
        • Investigador principal:
          • Raziel O.C. Nunes, Medical Clinic Specialist
      • Aracaju, Sergipe, Brasil, 49069021
        • Reclutamiento
        • Newdata Clinical Research
        • Contacto:
        • Investigador principal:
          • Alex V. C. França, Hepatologist
        • Sub-Investigador:
          • Raziel O. C. Nunes, Medical Clinic Specialist
      • Aracaju, Sergipe, Brasil, 49072720
        • Aún no reclutando
        • Associação Aracajuana Hospital Santa Isabel
        • Contacto:
        • Investigador principal:
          • Raziel O.C. Nunes, Medical Clinic Specialist
    • São Paulo
      • Bragança Paulista, São Paulo, Brasil, 12916542
        • Aún no reclutando
        • Husf Hospital Universitário São Francisco Na Providência de Deus
        • Investigador principal:
          • Gustavo P. R. Mamprin, Clinical Pathology
      • Bragança Paulista, São Paulo, Brasil, 12922160
        • Aún no reclutando
        • Newdata Clinical Research - Parkmed
        • Contacto:
        • Investigador principal:
          • Flávia G. S. B. Melhado, Ophthalmologist
      • São José dos Campos, São Paulo, Brasil, 12230000
        • Aún no reclutando
        • Cipes Centro Internacional de Pesquisa Clínica
        • Investigador principal:
          • Rosemeiry T. M. Melo, Otolaryngologist
      • São Paulo, São Paulo, Brasil, 01139000
        • Aún no reclutando
        • Synvia Clinical
        • Investigador principal:
          • Sophia A. Cavicchioli, Medical clinic
      • São Paulo, São Paulo, Brasil, 03164000
        • Aún no reclutando
        • Iscp Sociedade Educacional
        • Investigador principal:
          • Rogério S. Lopes, Medical Clinic Specialist
      • São Paulo, São Paulo, Brasil, 04037030
        • Aún no reclutando
        • RDSS Ricardo Diaz Scientific Solution
        • Investigador principal:
          • Ricardo S. Diaz, Infectious disease specialist
      • Valinhos, São Paulo, Brasil, 13271130
        • Aún no reclutando
        • A2Z Clinical Centro de Pesquisa Clínica
        • Investigador principal:
          • Mauricio W. P. Junior, Pulmonologist

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Grupo C
Placebo
Droga: Placebo
Placebo
Experimental: Group A
dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg
Droga: Placebo
Placebo
Droga: 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.
Comparador activo: Group B
dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg, coated tablet.
Droga: dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg
The differential of this intervention is the dosages

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of participants who show improvement in symptoms of nasal obstruction and/or congestion
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Brainfarma Industria Química e Farmacêutica S/A

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

8 de mayo de 2026

Finalización primaria (Estimado)

28 de junio de 2027

Finalización del estudio (Estimado)

30 de junio de 2027

Fechas de registro del estudio

Enviado por primera vez

19 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

2 de junio de 2026

Publicado por primera vez (Actual)

4 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

15 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • HYP007-24

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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