[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100241604":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":48,"locations":55,"responsibleParty":73,"collaborators":76,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":60,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":60,"maxAge":60,"enrollmentInfo":86,"targetDuration":60,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":60,"overallStatus":58,"whyStopped":60,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Tanta University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Orphenadrine(Norflex)","EXPERIMENTAL","50 patients will be treated with orphenadrine 100 mg twice daily for 1 month",[13],"Drug: orphenadrine",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","50 patients will be given placebo",[19],"Drug: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","orphenadrine","Orphenadrine in muscle cramps in cirrhotic patients",[9],[27],"Norflex",{"type":22,"name":15,"description":29,"armGroupLabels":30,"otherNames":31},"calcium in muscle cramps in cirrhotic patients",[15],[32],"calcium",[34,38,41,43,45],{"name":35,"affiliation":36,"role":37},"Asem A Elfert, Professor","TUH","PRINCIPAL_INVESTIGATOR",{"name":39,"affiliation":36,"role":40},"Samah Mosaad, Lecturer","STUDY_CHAIR",{"name":42,"affiliation":36,"role":40},"Lobna Aboaly, Professor",{"name":44,"affiliation":36,"role":40},"Walaa ElKhalawany, Lecturer",{"name":46,"affiliation":36,"role":47},"Sherief Abd-Elsalam, Lecturer","STUDY_DIRECTOR",[49],{"name":50,"role":51,"phone":52,"phoneExt":53,"email":54},"Sherief M Abd-Elsalam, lecturer","CONTACT","01000058842","002","Sherif_tropical@yahoo.com",[56],{"facility":57,"status":58,"city":59,"state":60,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"Tanta university hospital","RECRUITING","Tanta",null,"Egypt","EG",{"type":64,"coordinates":65},"Point",[66,67],31.00192,30.78847,{"lat":67,"lon":66},[70],{"name":71,"role":51,"phone":72,"phoneExt":60,"email":54},"Sherief Abd-Elsalam","00201000040794",{"type":74,"investigatorFullName":71,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":60,"oldOrganization":60},"SPONSOR_INVESTIGATOR","Study director",[77],{"name":5,"class":6},"100241604","phase-3-study-of-orphenadrine-in-the-treatment-of-muscle-cramps-in-patients-with-cirrhosis-100241604",false,"NCT02423395","Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis","Randomized Study of Orphenadrine' in the Treatment of Muscle Cramps in Patients With Cirrhosis","Inclusion Criteria:\n\n* Cirrhosis\n* Muscle cramps( ≥3 cramps per week )\n\nExclusion Criteria:\n\n* • Allergy to orphenadrine\n\n  * Renal impairment\n  * Pregnant and lactating women\n  * Peripheral vascular disease\n  * Peripheral neuropathy\n  * Medications as calcium channel blockers, conjugated estrogens and naproxen. Glaucoma Prostatic enlargement","ALL",{"count":87,"type":88},100,"ESTIMATED","INTERVENTIONAL",[91],"PHASE3","Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume\u002Felectrolytes (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. \\[3,4\\]",[94,95],"Liver Cirrhosis","Muscle Cramps","2019-06-06",{"date":98,"type":99},"2019-06-07","ACTUAL",{"date":101,"type":60},"2015-01",{"date":103,"type":88},"2028-12",{"name":71,"class":6},1]