[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nasal-congestion\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nasal-congestion":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100642484","phase-3-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-100642484",false,"NCT07626437","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","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","PANAMA","Inclusion Criteria:\n\n* The following criteria must be met for the participant to be included in the study:\n\n  1. Participants of both sexes, aged between 18 and 60 years.\n  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.\n  3. Present symptoms of nasal obstruction and\u002For 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).\n  4. Must not have used any medication for symptomatic treatment of the condition.\n  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\\*\\*.\n\n     \\* Female sterilization (bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation performed at least 6 weeks before administration of the investigational product.\n\n     \\*\\* 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\u002For hormonal contraceptive methods (estrogenic and\u002For 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.\n\n     Exclusion Criteria:\n* A positive response to any of the following criteria will exclude the participant from the study:\n\n  1. Participants with COVID-19, diagnosed by rapid antigen test and\u002For RT-PCR for SARS-CoV-2;\n  2. Previous contact with individuals diagnosed with COVID-19 within 14 days prior to screening;\n  3. Vaccination against influenza and\u002For COVID-19 within 7 days prior to the study;\n  4. Presence of gastrointestinal symptoms and\u002For dyspnea associated with cold or flu symptoms;\n  5. Clinical history consistent with bacterial upper respiratory tract infection requiring antibiotic therapy;\n  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;\n  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;\n  8. History of hypersensitivity to analgesics, antirheumatic drugs, and\u002For alcoholic beverages;\n  9. Participants allergic to foods, hair dyes, and\u002For preservatives;\n  10. Participants dependent on decongestants (topical, nasal, or oral) or receiving allergen-specific immunotherapy;\n  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\u002For tranquilizers;\n  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);\n\n      * 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%).\n  13. Pregnant or breastfeeding women, or those intending to become pregnant during the study period;\n  14. Participation in a clinical study within the last 12 months, at the investigator's discretion;\n  15. Any condition that, in the physician's judgment, may interfere with participation in the study.","ALL","18 Years","60 Years",{"count":21,"type":22},620,"ESTIMATED","INTERVENTIONAL",[25],"PHASE3","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.",[28,29,30],"Common Cold\u002FFlu","Nasal Congestion","Nasal Obstruction",[32,33,34,35,36,37,38,39],"nasal congestion","flu","cold","dipyrone","dipyrone monohydrate","caffeine","chlorpheniramine maleate","nasal obstruction","RECRUITING","2026-06-15",{"date":43,"type":44},"2026-06-16","ACTUAL",{"date":46,"type":44},"2026-05-08",{"date":48,"type":22},"2027-06-30",{"name":50,"class":51},"Brainfarma Industria Química e Farmacêutica S\u002FA","INDUSTRY",15,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":11,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":64,"phases":4,"briefSummary":65,"conditions":66,"keywords":71,"overallStatus":79,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":5},"100612718","post-market-clinical-follow-up-study-of-an-isotonic-saline-solution-to-manage-nasal-congestion-in-case-of-flu-symptoms-colds-allergic-rhinitis-and-rhinosinusitis-in-infants-and-toddlers-100612718","NCT07257224","Post-market Clinical Follow-up Study of an Isotonic Saline Solution to Manage Nasal Congestion in Case of Flu Symptoms, Colds, Allergic Rhinitis and Rhinosinusitis in Infants and Toddlers","Nasal Baby","Inclusion Criteria:\n\n* Male and female infants \u002F toddlers aged 3 to 48 months (inclusive) at the time of enrolment.\n* Subjects with flu, cold, allergic rhinitis or rhinosinusitis as reported by their legal guardian(s) and\u002For medical history.\n* Subjects presenting at least moderately bothersome nasal congestion (blocked or stuffy nose) as reported by their legal guardian(s) and\u002For medical history and confirmed by the site investigator through non-diagnostic inspection.\n* Subjects suitable for nasal hygiene treatment with the study device according to its IFU.\n* Subjects with nasal congestion symptoms that began within 48 hours prior to enrolment.\n* Subjects whose legal guardian(s) signed written informed consent on their behalf to participate in the study.\n* Subject whose legal guardian(s) are willing and able to follow the IFU and comply with all study procedures.\n\nExclusion Criteria (if any severe symptoms are seen in the subject, the guardian will be advised to seek medical evaluation by the subject's physician):\n\n* Subjects with known hypersensitivity or intolerance to seawater or any of its natural mineral components (e.g., sodium, chloride, magnesium) as reported by their legal guardian(s) and\u002For medical history.\n* Subjects showing severe symptoms such as persistent fever (\\>38°C), severe cough, ear pain, or respiratory distress, as reported by their legal guardian(s) and\u002For medical history.\n* Subjects whose legal guardian(s) and\u002For medical history report any ongoing medical diagnosis or treatment for acute infection or chronic respiratory disease (e.g., asthma, pneumonia, laryngotracheobronchitis, sinusitis, etc.).\n* Subjects whose legal guardians(s) and\u002For medical history report any type of immunodeficiency.\n* Subjects whose legal guardian(s) and\u002For medical history report a neurological condition that may affect respiratory functioning.\n* Subjects with visible nasal injury, wounds or bleeding, or any condition that may contraindicate the use of the study device according to the device IFU.\n* Subjects who are currently participating or have participated in another clinical investigation within the last 30 days prior to enrolment.\n* Subjects using saline nasal drops or nasal sprays or pumps other than the study product within 12 hours prior to the time of enrolment or during the study.\n* Subjects using the study product within 24 hours prior to the time of enrolment in the study.\n* Subject using antibiotics, antivirals, intranasal medications, decongestants, antihistamines, mucolytics, echinacea, combination cold formulas, supplements containing ≥ 10 mg zinc that could influence symptom scores within 12 hours prior to the time of enrolment or during the study.","3 Months","48 Months",{"count":63,"type":22},83,"OBSERVATIONAL","The goal of this observational post-market clinical follow-up study is to evaluate the safety and performance of the CE-marked nasal spray in the management of nasal congestion in case of flu, colds, allergic rhinitis and rhinosinusitis in infants and toddlers aged 3 to 48 months at day 5 post-enrolment. Enrolment does not require establishing a medical diagnosis; eligibility is based on guardian-reported nasal congestion consistent with lay use of the device.\n\nParticipants will be:\n\n* Evaluated by a healthcare professional for eligibility.\n* Receive treatment with the CE-marked nasal spray according to its Instructions for Use, for up to 14 days.\n* Have their legal guardians report symptom severity and improvement using standardized scales (Visual Analog Scale) during follow-up visits on Day 2, Day 5, and Day 14 and device usability on Day 14.\n\nThis study does not include a comparison group and reflects real-world use of the device in routine pediatric care.",[29,67,68,69,70],"Common Cold","Allergic Rhinitis","Rhinosinusitis","Flu Symptom",[72,73,74,75,76,77,78],"infants","toddlers","Upper Respiratory Tract Infections","Pediatric nasal spray","nasal spray","Seawater isotonic solution","Post-market clinical follow-up (PMCF)","NOT_YET_RECRUITING","2025-11-20",{"date":82,"type":44},"2025-12-02",{"date":84,"type":22},"2025-12",{"date":86,"type":22},"2026-11",{"name":88,"class":51},"Laboratoires Quinton International S.L."]