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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)

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

620

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Brasilien
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brasilien, 30455610
        • Ikke rekrutterer endnu
        • Instituto Anima de Extensão Universitária - Unibh
        • Ledende efterforsker:
          • Luan F. Santos, Pulmonologist
      • Vespasiano, Minas Gerais, Brasilien, 33200664
        • Ikke rekrutterer endnu
        • Centro de Ensino Superior de Vespasiano
        • Ledende efterforsker:
          • Fernanda C. Perreiras, General/Surgical Oncologist
    • Pará
      • Belém, Pará, Brasilien, 66093681
        • Ikke rekrutterer endnu
        • Norte Pesquisa Clínica
        • Ledende efterforsker:
          • Roberta K. Santos, Pulmonology
    • Rio Grande do Norte
      • Natal, Rio Grande do Norte, Brasilien, 59076000
        • Ikke rekrutterer endnu
        • Apec Sociedade Potiguar de Educação E Cultura
        • Ledende efterforsker:
          • Igor T. B. Q. Silva, Infectious disease specialist
    • Santa Catarina
      • Palhoça, Santa Catarina, Brasilien, 88137270
        • Ikke rekrutterer endnu
        • Instituto Anima de Extensão Universitária - Unisul
        • Ledende efterforsker:
          • Jefferson L. Traebert, Epidemiologist
    • Sergipe
      • Aracaju, Sergipe, Brasilien, 49055480
        • Ikke rekrutterer endnu
        • Fundação de Beneficência Hospital de Cirurgia
        • Kontakt:
        • Ledende efterforsker:
          • Alex V. C. França, Hepatologist
        • Underforsker:
          • Raziel O.C. Nunes, Medical Clinic Specialist
      • Aracaju, Sergipe, Brasilien, 49069021
        • Rekruttering
        • Newdata Clinical Research
        • Kontakt:
        • Ledende efterforsker:
          • Alex V. C. França, Hepatologist
        • Underforsker:
          • Raziel O. C. Nunes, Medical Clinic Specialist
      • Aracaju, Sergipe, Brasilien, 49072720
        • Ikke rekrutterer endnu
        • Associação Aracajuana Hospital Santa Isabel
        • Kontakt:
        • Ledende efterforsker:
          • Alex V. C. França, Hepatologist
        • Underforsker:
          • Raziel O.C. Nunes, Medical Clinic Specialist
    • São Paulo
      • Bragança Paulista, São Paulo, Brasilien, 12916542
        • Ikke rekrutterer endnu
        • Husf Hospital Universitário São Francisco Na Providência de Deus
        • Ledende efterforsker:
          • Gustavo P. R. Mamprin, Clinical Pathology
      • Bragança Paulista, São Paulo, Brasilien, 12922160
        • Ikke rekrutterer endnu
        • Newdata Clinical Research - Parkmed
        • Kontakt:
        • Ledende efterforsker:
          • Flávia G. S. B. Melhado, Ophthalmologist
      • São José dos Campos, São Paulo, Brasilien, 12230000
        • Ikke rekrutterer endnu
        • Cipes Centro Internacional de Pesquisa Clínica
        • Ledende efterforsker:
          • Rosemeiry T. M. Melo, Otolaryngologist
      • São Paulo, São Paulo, Brasilien, 01139000
        • Ikke rekrutterer endnu
        • Synvia Clinical
        • Ledende efterforsker:
          • Sophia A. Cavicchioli, Medical clinic
      • São Paulo, São Paulo, Brasilien, 03164000
        • Ikke rekrutterer endnu
        • Iscp Sociedade Educacional
        • Ledende efterforsker:
          • Rogério S. Lopes, Medical Clinic Specialist
      • São Paulo, São Paulo, Brasilien, 04037030
        • Ikke rekrutterer endnu
        • Rdss Ricardo Diaz Scientific Solution
        • Ledende efterforsker:
          • Ricardo S. Diaz, Infectious disease specialist
      • Valinhos, São Paulo, Brasilien, 13271130
        • Ikke rekrutterer endnu
        • A2Z Clinical Centro de Pesquisa Clínica
        • Ledende efterforsker:
          • Mauricio W. P. Junior, Pulmonologist

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Gruppe C
Placebo
Medicin: Placebo
Placebo
Eksperimentel: Group A
dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg
Medicin: Placebo
Placebo
Medicin: 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.
Aktiv komparator: Group B
dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg, coated tablet.
Medicin: dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg
The differential of this intervention is the dosages

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Proportion of participants who show improvement in symptoms of nasal obstruction and/or congestion
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Brainfarma Industria Química e Farmacêutica S/A

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. maj 2026

Primær færdiggørelse (Anslået)

28. juni 2027

Studieafslutning (Anslået)

30. juni 2027

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

4. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

4. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HYP007-24

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

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Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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