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New Triple-Action pill takes on cold and flu symptoms

NCT ID NCT07626437

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 620 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 60 years

Sex

Anyone

Healthy volunteers

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

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.

common cold influenza Nasal Obstruction

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.

  1. The places running it

    15 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • A2Z Clinical Centro de Pesquisa Clínica

    NOT_YET_RECRUITING

    Valinhos, São Paulo, 13271130, Brazil

  • Apec Sociedade Potiguar de Educação E Cultura

    NOT_YET_RECRUITING

    Natal, Rio Grande do Norte, 59076000, Brazil

  • Associação Aracajuana Hospital Santa Isabel

    NOT_YET_RECRUITING

    Aracaju, Sergipe, 49072720, Brazil

  • Centro de Ensino Superior de Vespasiano

    NOT_YET_RECRUITING

    Vespasiano, Minas Gerais, 33200664, Brazil

  • Cipes Centro Internacional de Pesquisa Clínica

    NOT_YET_RECRUITING

    São José dos Campos, São Paulo, 12230000, Brazil

  • Fundação de Beneficência Hospital de Cirurgia

    NOT_YET_RECRUITING

    Aracaju, Sergipe, 49055480, Brazil

  • Husf Hospital Universitário São Francisco Na Providência de Deus

    NOT_YET_RECRUITING

    Bragança Paulista, São Paulo, 12916542, Brazil

  • Instituto Anima de Extensão Universitária - Unibh

    NOT_YET_RECRUITING

    Belo Horizonte, Minas Gerais, 30455610, Brazil

  • Instituto Anima de Extensão Universitária - Unisul

    NOT_YET_RECRUITING

    Palhoça, Santa Catarina, 88137270, Brazil

  • Iscp Sociedade Educacional

    NOT_YET_RECRUITING

    São Paulo, São Paulo, 03164000, Brazil

  • Newdata Clinical Research

    RECRUITING

    Aracaju, Sergipe, 49069021, Brazil

  • Newdata Clinical Research - Parkmed

    NOT_YET_RECRUITING

    Bragança Paulista, São Paulo, 12922160, Brazil

  • Norte Pesquisa Clínica

    NOT_YET_RECRUITING

    Belém, Pará, 66093681, Brazil

  • Rdss Ricardo Diaz Scientific Solution

    NOT_YET_RECRUITING

    São Paulo, São Paulo, 04037030, Brazil

  • Synvia Clinical

    NOT_YET_RECRUITING

    São Paulo, São Paulo, 01139000, Brazil

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