[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586554":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":33,"centralContacts":47,"locations":58,"responsibleParty":81,"collaborators":63,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":63,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":61,"whyStopped":63,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"Laboratorios Silanes S.A. de C.V.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Group A: Desloratadine 5 mg + Betamethasone 0.25 mg","EXPERIMENTAL","Administered orally, one tablet a day, for 10 days.",[13],"Drug: Desloratadine \u002F Betamethasone in fixed dose",{"label":15,"type":16,"description":11,"interventionNames":17},"Group B: Desloratadine 5 mg","ACTIVE_COMPARATOR",[18],"Drug: Desloratadine",[20,27],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Desloratadine \u002F Betamethasone in fixed dose","1 tablet, once a day of 5 mg \u002F 0.25 mg",[9],[26],"DESLORA \u002F BETA",{"type":21,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"Desloratadine","1 tablet, once a day of 5 mg",[15],[32],"DESLORA",[34,38,41,44],{"name":35,"affiliation":36,"role":37},"Francisco Murguía Martín, MD","Unidad de Medicina Especializada SMA","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":40,"role":37},"Tobías Avendaño Santiago, MD","Oaxaca Site Management Organization, S.C",{"name":42,"affiliation":43,"role":37},"Erika N Durón López, MD","Centro de Investigación Médica de Aguascalientes",{"name":45,"affiliation":46,"role":37},"María D Escobar Zalapa, MD","CICMEX Centro de Investigación Clínica de México S de RL de CV",[48,54],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},"Jorge A Gonzalez, PhD","CONTACT","5254883785","3761","jogonzalez@silanes.com.mx",{"name":55,"role":50,"phone":51,"phoneExt":56,"email":57},"Yulia Romero-Antonio, B.S.","3777","yromero@silanes.com.mx",[59],{"facility":60,"status":61,"city":62,"state":63,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Laboratorio Silanes, S.A. de C.V.","RECRUITING","Mexico City",null,"11000","Mexico","MX",{"type":68,"coordinates":69},"Point",[70,71],-99.12766,19.42847,{"lat":71,"lon":70},[74,75,77,78,79,80],{"name":49,"role":50,"phone":51,"phoneExt":52,"email":53},{"name":55,"role":50,"phone":76,"phoneExt":56,"email":57},"5554883700",{"name":35,"role":37,"phone":63,"phoneExt":63,"email":63},{"name":39,"role":37,"phone":63,"phoneExt":63,"email":63},{"name":42,"role":37,"phone":63,"phoneExt":63,"email":63},{"name":45,"role":37,"phone":63,"phoneExt":63,"email":63},{"type":82,"investigatorFullName":63,"investigatorTitle":63,"investigatorAffiliation":63,"oldNameTitle":63,"oldOrganization":63},"SPONSOR","100586554","phase-3-confirmatory-study-on-the-efficacy-and-safety-of-the-fixed-dose-combination-of-desloratadinebetamethasone-versus-desloratadine-100586554",false,"NCT06916884","Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine\u002FBetamethasone Versus Desloratadine","Confirmatory Study on the Efficacy and Safety of the Fixed-dose Combination of Desloratadine\u002FBetamethasone Versus Desloratadine as Treatment in Patients With Allergic Rhinitis","DESCUBRA","Inclusion Criteria:\n\n* Willing to participate in the study and able to provide written informed consent.\n* Clinical diagnosis (based on medical history and physical examination) of active allergic rhinitis at study entry.\n* Patients presenting with moderate to severe nasal symptoms, with a Total Nasal Symptom Score (TNSS) ≥5.\n* In the case of women of childbearing potential who are sexually active, the use of an acceptable contraceptive method (barrier and\u002For hormonal), as determined by the investigator.\n* In the opinion of the Principal Investigator or treating physician, the patient is indicated for treatment with the investigational product and may derive clinical benefit from it.\n\nExclusion Criteria:\n\n* Patients for whom the investigational drug is medically contraindicated.\n* Known allergy or hypersensitivity to the active ingredient, study medications, related products, or excipients.\n* History of nasal trauma (surgical or accidental) within the past week.\n* Positive pregnancy test, pregnant or breastfeeding women, or women planning to become pregnant during the course of the study.\n* Acute or chronic lower or upper respiratory tract infections, such as the common cold, influenza, pneumonia, bronchitis, or chronic sinusitis.\n* History of non-allergic rhinitis, such as chronic non-allergic rhinitis, drug-induced rhinitis, atrophic rhinitis, hormonal rhinitis, or unilateral rhinitis, as reported in the medical history or patient interview.\n* History of nasal polyposis, primary ciliary dyskinesia syndrome, and\u002For non-allergic rhinitis with eosinophilia syndrome (NARES).\n* Current smokers, or history of alcohol and\u002For drug abuse in the past year according to DSM-V criteria.\n* History of seizure disorders, status epilepticus, or generalized tonic-clonic seizures.\n* History of chronic hepatic failure classified as Child-Pugh C, as reported in the medical history or patient interview.\n* History of chronic renal failure (glomerular filtration rate \\\u003C 30 mL\u002Fmin\u002F1.73 m²), as reported in the medical history or patient interview.\n* Any condition, in the investigator's opinion, that affects prognosis or precludes outpatient management, which must be evaluated by the principal investigator to determine the subject's eligibility.\n* History of severe, progressive, unstable, or advanced disease of any kind that could interfere with efficacy and safety evaluations or pose a risk to the patient.\n* Oncology patients (except those with basal cell skin cancer) or patients with serious illnesses who, in the investigator's opinion, have a poor prognosis or life expectancy of less than one year, including those with mental health disorders.\n* Active participation in another clinical trial involving an investigational treatment or participation in any clinical study within the previous two weeks.\n* Patients whose participation in the study may be influenced (e.g., employees of the research center or sponsor, incarcerated individuals, etc.).\n* Patients with symptoms suggestive of active COVID-19 infection (e.g., fever, cough, dyspnea) and\u002For contact within the past 14 days with a suspected or confirmed COVID-19 case and\u002For a positive COVID-19 test.","ALL","18 Years","60 Years",{"count":95,"type":96},70,"ESTIMATED","INTERVENTIONAL",[99],"PHASE3","Phase IIIb , longitudinal, multicenter, randomized, double-blind, to evaluate efficacy and safety of the fixed-dose combination of Desloratadine 5 mg \u002F Betamethasone 0.25 mg versus Desloratadine 5 mg monotherapy as treatment for symptoms associated with allergic rhinitis.",[102],"Allergic Rhinitis",[104,105,106],"rhinitis","allergies","respiratory system","2025-04-01",{"date":109,"type":110},"2025-04-08","ACTUAL",{"date":112,"type":110},"2024-11-11",{"date":114,"type":96},"2025-06-11",{"name":5,"class":6},1]