[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100336299":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":25,"locations":34,"responsibleParty":47,"collaborators":25,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":25,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":25,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":70,"whyStopped":25,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":79},{"fullName":5,"class":6},"Dr. August Wolff GmbH & Co. KG Arzneimittel","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"WO3970","EXPERIMENTAL","Formulation containing WO3979 for topical application",[13],"Drug: WO3970",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo of WO3988","PLACEBO_COMPARATOR","Formulation containing Placebo of WO3988 for topical application",[19],"Drug: Placebo (WO3988)",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Application of cream to each axilla",[9],null,{"type":22,"name":27,"description":23,"armGroupLabels":28,"otherNames":25},"Placebo (WO3988)",[15],[30],{"name":31,"affiliation":32,"role":33},"Prof. Rolf-Markus Szeimies, MD","Klinikum Vest GmbH, Knappschaftskrankenhaus Recklinghausen","PRINCIPAL_INVESTIGATOR",[35],{"facility":36,"status":25,"city":37,"state":25,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":25},"Dr. Harald Brüning","Kiel","24148","Germany","DE",{"type":42,"coordinates":43},"Point",[44,45],10.13489,54.32133,{"lat":45,"lon":44},{"type":48,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100336299","phase-3-assessment-of-efficacy-and-safety-of-topical-administration-of-1-glycopyrronium-bromide-gpb-in-patients-with-primary-axillary-hyperhidrosis-and-the-assessment-of-long-term-efficacy-and-safety-of-topical-administration-of-1-gpb-cream-in-patients-with-primary-axillary-hyperhidrosis-100336299",false,"NCT03658616","Assessment of Efficacy and Safety of Topical Administration of 1% Glycopyrronium Bromide (GPB) in Patients With Primary Axillary Hyperhidrosis and the Assessment of Long-term Efficacy and Safety of Topical Administration of 1% GPB Cream in Patients With Primary Axillary Hyperhidrosis.","Combined Randomized, Double-blind, Dose-confirming Phase 3a Study in Parallel Design to Assess the Efficacy and Safety of Topical 4-week Treatment With 1% GPB Cream vs Placebo and Open-label Phase 3b Study to Assess Long-term Efficacy and Safety in Patients With Primary Axillary Hyperhidrosis Treated With 1% GPB Cream","Inclusion Criteria:\n\n* Diagnosis of severe primary axillary hyperhidrosis with a HDSS score of 3 or 4\n* At least 50 mg of sweat production in each axilla measured gravimetrically at room temperature and at a humidity consistent with the normal climate in that area over a period of 5 minutes (patients should have acclimatized to that room for at least 30 minutes)\n* Men and women aged 18 to 65 years at the time of informed consent with a body mass index of 18-32 kg\u002Fm2\n* Able to comply with protocol requirements, including overnight stays, blood sample collections as defined in the protocol subjects\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Known allergy to any of the components in the investigational product.\n* Hypersensitivity against glycopyrrolate\n* Secondary hyperhidrosis, for example, hyperhidrosis that is secondary to other underlying diseases including hyperthyroidism, lymphoma and malaria, climacteric hyperhidrosis.\n* Previous surgical treatment of hyperhidrosis including sympathectomy, surgical debulking of the sweat glands, subcutaneous tissue curettage and ultrasonic surgery.\n* Botulinum toxin treatment in the prior 4 months.\n* Angle closure glaucoma or its precipitation (narrow angle).\n* Mycotic, other skin infections and other dermal disorder including infection at anticipated application sites in either axilla.\n* Any condition or situation that, in the investigator's or sub-investigator's opinion, may interfere with the patient's participation in the study;","ALL","18 Years","65 Years",{"count":60,"type":61},518,"ACTUAL","INTERVENTIONAL",[64],"PHASE3","The aim of this study is to investigate the efficacy and safety of 1% GPB cream after 4 weeks of treatment compared with placebo with a sufficient number of patients to obtain statistically significant results, and to assess the long-term safety of 1% GPB cream.",[67],"Primary Axillary Hyperhidrosis",[69],"Excessive sweating","COMPLETED","2023-04-27",{"date":73,"type":61},"2023-04-28",{"date":75,"type":61},"2018-09-18",{"date":77,"type":61},"2022-02-02",{"name":5,"class":6},1]