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New treatment option for Common Cold/Flu
Official title 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
ClinicalTrials.gov ID: NCT07626437
What this study is testing
What is dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg?
dipyrone monohydrate 1000 mg + chlorpheniramine maleate 4 mg + caffeine 60 mg is an investigational medicine, being studied as a potential treatment for common cold/flu.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- The following criteria must be met for the participant to be included in the study:
- Participants of both sexes, aged between 18 and 60 years.
- Be able to understand, agree to participate in the study, comply with procedures, and attend visits, as indicated by signing the informed consent...
- Present symptoms of nasal obstruction and/or congestion due to the common cold or influenza, with onset within less than 48 hours, with symptoms...
- Must not have used any medication for symptomatic treatment of the condition.
You likely can't join if
- A positive response to any of the following criteria will exclude the participant from the study:
- Participants with COVID-19, diagnosed by rapid antigen test and/or RT-PCR for SARS-CoV-2;
- Previous contact with individuals diagnosed with COVID-19 within 14 days prior to screening;
- Vaccination against influenza and/or COVID-19 within 7 days prior to the study;
- Presence of gastrointestinal symptoms and/or dyspnea associated with cold or flu symptoms;
- Clinical history consistent with bacterial upper respiratory tract infection requiring antibiotic therapy;
See the full eligibility criteria
- The following criteria must be met for the participant to be included in the study:
- Participants of both sexes, aged between 18 and 60 years.
- 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.
- 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...
- Must not have used any medication for symptomatic treatment of the condition.
- 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...
- A positive response to any of the following criteria will exclude the participant from the study:
- Participants with COVID-19, diagnosed by rapid antigen test and/or RT-PCR for SARS-CoV-2;
- Previous contact with individuals diagnosed with COVID-19 within 14 days prior to screening;
- Vaccination against influenza and/or COVID-19 within 7 days prior to the study;
- Presence of gastrointestinal symptoms and/or dyspnea associated with cold or flu symptoms;
- Clinical history consistent with bacterial upper respiratory tract infection requiring antibiotic therapy;
- 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...
- Diagnosis of: congenital glucose-6-phosphate dehydrogenase deficiency, prothrombin deficiency, gastroduodenal ulcer, hepatic porphyria, narrow-angle glaucoma, chronic nephritis, blood dyscrasias, asthma, chronic...
- History of hypersensitivity to analgesics, antirheumatic drugs, and/or alcoholic beverages;
- Participants allergic to foods, hair dyes, and/or preservatives;
- Participants dependent on decongestants (topical, nasal, or oral) or receiving allergen-specific immunotherapy;
- Use of monoamine oxidase inhibitors (phenelzine, iproniazid, isocarboxazid, harmaline, nialamide, pargyline, selegiline, toloxatone, tranylcypromine, moclobemide), cyclosporine, chlorpromazine, barbiturates...
- 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...
- Pregnant or breastfeeding women, or those intending to become pregnant during the study period;
- Participation in a clinical study within the last 12 months, at the investigator's discretion;
- Any condition that, in the physician's judgment, may interfere with participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Belo Horizonte, Minas Gerais, Brazil
- Vespasiano, Minas Gerais, Brazil
- Belém, Pará, Brazil
- Natal, Rio Grande do Norte, Brazil
- Palhoça, Santa Catarina, Brazil
- Aracaju, Sergipe, Brazil
- Bragança Paulista, São Paulo, Brazil
- São José dos Campos, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Valinhos, São Paulo, Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Belo Horizonte, Minas Gerais, Brazil; Vespasiano, Minas Gerais, Brazil; Belém, Pará, Brazil; Natal, Rio Grande do Norte, Brazil; Palhoça, Santa Catarina, Brazil; Aracaju, Sergipe, Brazil and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.