New Triple-Action pill takes on cold and flu symptoms
NCT ID NCT07626437
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new pill containing three ingredients (dipyrone, caffeine, and chlorpheniramine) to see if it works as well as a standard cold medicine for relieving stuffy nose and other cold and flu symptoms. About 620 adults with early cold or flu symptoms will take either the new pill, the standard medicine, or a placebo for a few days. The main goal is to see how many people feel better after 3 days.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 620 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
15 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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A2Z Clinical Centro de Pesquisa Clínica
NOT_YET_RECRUITINGValinhos, São Paulo, 13271130, Brazil
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Apec Sociedade Potiguar de Educação E Cultura
NOT_YET_RECRUITINGNatal, Rio Grande do Norte, 59076000, Brazil
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Associação Aracajuana Hospital Santa Isabel
NOT_YET_RECRUITINGAracaju, Sergipe, 49072720, Brazil
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Centro de Ensino Superior de Vespasiano
NOT_YET_RECRUITINGVespasiano, Minas Gerais, 33200664, Brazil
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Cipes Centro Internacional de Pesquisa Clínica
NOT_YET_RECRUITINGSão José dos Campos, São Paulo, 12230000, Brazil
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Fundação de Beneficência Hospital de Cirurgia
NOT_YET_RECRUITINGAracaju, Sergipe, 49055480, Brazil
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Husf Hospital Universitário São Francisco Na Providência de Deus
NOT_YET_RECRUITINGBragança Paulista, São Paulo, 12916542, Brazil
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Instituto Anima de Extensão Universitária - Unibh
NOT_YET_RECRUITINGBelo Horizonte, Minas Gerais, 30455610, Brazil
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Instituto Anima de Extensão Universitária - Unisul
NOT_YET_RECRUITINGPalhoça, Santa Catarina, 88137270, Brazil
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Iscp Sociedade Educacional
NOT_YET_RECRUITINGSão Paulo, São Paulo, 03164000, Brazil
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Newdata Clinical Research
RECRUITINGAracaju, Sergipe, 49069021, Brazil
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Newdata Clinical Research - Parkmed
NOT_YET_RECRUITINGBragança Paulista, São Paulo, 12922160, Brazil
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Norte Pesquisa Clínica
NOT_YET_RECRUITINGBelém, Pará, 66093681, Brazil
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Rdss Ricardo Diaz Scientific Solution
NOT_YET_RECRUITINGSão Paulo, São Paulo, 04037030, Brazil
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Synvia Clinical
NOT_YET_RECRUITINGSão Paulo, São Paulo, 01139000, Brazil
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