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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. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

620

Fase

  • Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Dobbelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Placebo komparator: Gruppe C
Placebo
Legemiddel: Placebo
Placebo
Eksperimentell: Group A
dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg
Legemiddel: Placebo
Placebo
Legemiddel: 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.
Legemiddel: dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg
The differential of this intervention is the dosages

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Brainfarma Industria Química e Farmacêutica S/A

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

8. mai 2026

Primær fullføring (Antatt)

28. juni 2027

Studiet fullført (Antatt)

30. juni 2027

Datoer for studieregistrering

Først innsendt

19. mai 2026

Først innsendt som oppfylte QC-kriteriene

2. juni 2026

Først lagt ut (Faktiske)

4. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

16. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HYP007-24

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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