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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)

2026年6月15日 更新者：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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

620

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

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

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

不

描述

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：C组
安慰剂
药品：安慰剂
安慰剂
实验性的：Group A
dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg
药品：安慰剂
安慰剂
药品：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.
有源比较器：Group B
dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg, coated tablet.
药品：dipyrone monohydrate 500 mg + chlorpheniramine maleate 2 mg + caffeine 30 mg
The differential of this intervention is the dosages

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Proportion of participants who show improvement in symptoms of nasal obstruction and/or congestion
大体时间：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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Brainfarma Industria Química e Farmacêutica S/A

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年5月8日

初级完成 (估计的)

2027年6月28日

研究完成 (估计的)

2027年6月30日

研究注册日期

首次提交

2026年5月19日

首先提交符合 QC 标准的

2026年6月2日

首次发布 (实际的)

2026年6月4日

研究记录更新

最后更新发布 (实际的)

2026年6月16日

上次提交的符合 QC 标准的更新

2026年6月15日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • HYP007-24

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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