[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637582":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":37,"centralContacts":41,"locations":29,"responsibleParty":50,"collaborators":29,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":29,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":29,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":75,"overallStatus":82,"whyStopped":29,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":29},{"fullName":5,"class":6},"Medical University of Vienna","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"m-Cresol 0.1%","EXPERIMENTAL","Participants receive a 300 µl subcutaneous injection of m-Cresol at a concentration of 0.1%.",[13],"Other: m-Cresol 0.1%",{"label":15,"type":10,"description":16,"interventionNames":17},"m-Cresol 0.25%","Participants receive a 300 µl subcutaneous injection of m-Cresol at a concentration of 0.25%.",[18],"Other: m-Cresol 0.25%",{"label":20,"type":21,"description":22,"interventionNames":23},"Control solution","PLACEBO_COMPARATOR","Participants receive a 300 µl subcutaneous injection of control solution.",[24],"Other: Control Solution",[26,30,33],{"type":6,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"A preservative administered subcutaneously at 0.1%, a common concentration used in medicines.",[9],null,{"type":6,"name":15,"description":31,"armGroupLabels":32,"otherNames":29},"A preservative administered subcutaneously at 0.25%, a common concentration used in medicines.",[15],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":29},"Control Solution","A control solution administered subcutaneously.",[20],[38],{"name":39,"affiliation":5,"role":40},"Michael J.M. Fischer","PRINCIPAL_INVESTIGATOR",[42,47],{"name":43,"role":44,"phone":45,"phoneExt":29,"email":46},"Felix J. Resch","CONTACT","+43 1 40160 31419","felix.resch@meduniwien.ac.at",{"name":39,"role":44,"phone":48,"phoneExt":29,"email":49},"+43 1 40160 31410","michael.jm.fischer@meduniwien.ac.at",{"type":40,"investigatorFullName":51,"investigatorTitle":52,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Stefan Heber","Principal Investigator","100637582","early-phase-1-pain-induced-by-m-cresol-as-preservative-100637582",false,"NCT07600814","Pain Induced by m-Cresol as Preservative","Pain Induced by m-Cresol as Preservative - A Randomised Controlled Crossover-Trial in Healthy Volunteers","Inclusion criteria\n\n* Age between 18 and 70 years\n* Full legal capacity Exclusion criteria\n* Participant of another study, ongoing or within the last four weeks\n* Current medication intake (except hormonal contraception) or drug abuse\n* Female subjects: Positive pregnancy test or breastfeeding\n* Body temperature above 38°C, verified by infrared thermometer\n* Known allergic diseases, in particular asthmatic disorders and skin diseases\n* Sensory deficit, skin disease or hematoma of unknown origin in the examination of the test site",true,"ALL","18 Years","70 Years",{"count":65,"type":66},18,"ESTIMATED","INTERVENTIONAL",[69],"EARLY_PHASE1","Preservatives such as m-Cresol are essential components in many subcutaneously injected medications, including insulin or human growth hormone, to prevent bacterial growth. However, clinical reports have suggested that these preservatives may cause local discomfort or pain at the injection site, which can negatively impact treatment adherence. While m-Cresol is widely used, its direct contribution to injection-site pain has not yet been investigated in a prospective clinical trial.\n\nThis study aims to investigate whether subcutaneous injection of m-Cresol at concentrations commonly used in clinical practice (0.1% and 0.25%) cause significantly more pain than a preservative-free control solution. In a randomized, double-blind crossover design, healthy volunteers will receive three separate injections in a belly fold. Participants will rate their pain every 5 seconds until it subsides. The findings will help determine if m-Cresol is a primary source of injection-site pain and could lead to the development of more comfortable drug formulations.",[72,73,74],"Pain","Acute Pain","Healthy Volunteer Study",[76,77,78,79,80,81],"m-Cresol","Preservative","Subcutaneous Injection","Human Pain Models","Experimental Pain Models","Nociception","NOT_YET_RECRUITING","2026-05-15",{"date":85,"type":86},"2026-05-22","ACTUAL",{"date":88,"type":66},"2026-05-25",{"date":90,"type":66},"2026-06-08",{"name":5,"class":6}]