[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100615690":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":45,"collaborators":49,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":67,"studyType":68,"phases":10,"briefSummary":69,"conditions":70,"keywords":76,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Cardarelli Hospital","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Patients with acute, uncomplicated hemorrhoidal disease",null,"80 patients with acute, uncomplicated hemorrhoidal disease who sign informed consent and meet all eligibility criteria.",[13],"Drug: topical nifedipine 0.3% plus lidocaine 1.5%",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","topical nifedipine 0.3% plus lidocaine 1.5%","Transrectal and perianal application of nifedipine 0.3% plus lidocaine 1.5% cream twice daily for at least 21 days in patients with acute, uncomplicated hemorrhoidal disease",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Antonio Brillantino, MD, PhD","CONTACT","+393290119127","antonio.brillantino@gmail.com",[27],{"facility":28,"status":29,"city":30,"state":10,"zip":31,"country":32,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"Azienda Ospedaliera \"Antonio Cardarelli\", Napoli","RECRUITING","Naples","80131","Italy","IT",{"type":35,"coordinates":36},"Point",[37,38],14.26811,40.85216,{"lat":38,"lon":37},[41],{"name":42,"role":23,"phone":43,"phoneExt":10,"email":44},"Carmine Antropoli, MD","+393351221378","carmine.antropoli@aocardarelli.it",{"type":46,"investigatorFullName":47,"investigatorTitle":48,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Antonio Brillantino","MD, PhD",[50],{"name":51,"class":52},"Neopharmed Gentili S.p.A.","INDUSTRY","100615690","topical-nifedipine-03-plus-lidocaine-15-for-uncomplicated-hemorrhoidal-disease-100615690",false,"NCT07295886","Topical Nifedipine 0.3% Plus Lidocaine 1.5% for Uncomplicated Hemorrhoidal Disease","Observational Study on the Use of Topical Nifedipine 0.3% and Lidocaine 1.5% in Acute Uncomplicated Hemorrhoidal Disease","NILOS","Inclusion Criteria:\n\n* Male and female patients aged 18-75 years.\n* Clinical or anoscopic diagnosis of acute hemorrhoidal disease with prolapse severity between Grade II and IV (Goligher), possibly associated with external congestion.\n* Patients who started treatment with nifedipine 0.3% + lidocaine 1.5% within the past 5 days.\n* Availability of clinical evaluations at treatment initiation (proctologic visit and HDSS, SHS-HD, VAS scales).\n* Ability to understand the informed consent.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Acute hemorrhoidal disease complicated by thrombosis or strangulation.\n* Coagulopathies.\n* Active neoplastic disease.\n* Treatment with anticoagulants and\u002For chemotherapeutic agents.\n* Hypersensitivity to active substances, especially lidocaine (and other amide-type local anesthetics) or excipients.\n* Severe hypotensive states or cardiovascular insufficiency.\n* Pregnancy or breastfeeding.\n* Participation in clinical trials involving investigational drugs.","ALL","18 Years","75 Years",{"count":65,"type":66},80,"ESTIMATED","30 Days","OBSERVATIONAL","The goal of this observational study is to evaluate the effectiveness of topical nifedipine 0.3% plus lidocaine 1.5% for uncomplicated hemorrhoidal disease. The main question it aims to answer is:\n\nDoes topical nifedipine 0.3% plus lidocaine 1.5% lower symptoms in patients with uncomplicated acute hemorrhoidal disease? Participants already taking nifedipine 0.3% plus lidocaine 1.5% as part of their regular medical care for hemorrhoidal disease will undergo four visits over a 30-day period, including two telephone contacts and two in-person visits.",[71,72,73,74,75],"Hemorrhoid Bleeding","Hemorrhoids Prolapse","Hemorrhoid Pain","Hemorrhoid","Topical Administration",[77,78,79],"nifedipine 0.3% plus lidocaine 1.5%","uncomplicated hemorrhoidal disease","hemorrhoids symptoms","2025-12-19",{"date":82,"type":83},"2025-12-22","ACTUAL",{"date":85,"type":83},"2025-09-02",{"date":87,"type":66},"2026-05-02",{"name":5,"class":6},1]