[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100243479":3},{"organization":4,"armGroups":7,"interventions":36,"overallOfficials":54,"centralContacts":58,"locations":68,"responsibleParty":96,"collaborators":99,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":63,"studyType":119,"phases":120,"briefSummary":123,"conditions":124,"keywords":63,"overallStatus":71,"whyStopped":63,"lastUpdateSubmitDate":126,"lastUpdatePostDateStruct":127,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":135},{"fullName":5,"class":6},"Emory University","OTHER",[8,14,19,24,28,32],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard dose","EXPERIMENTAL","Subjects with sickle cell disease (SCD) and vaso-occlusive painful events (VOE) will be randomized to receive an intravenous (IV) infusion of a standard dose of arginine (100 mg\u002Fkg) three times a day for seven days or until discharged from the hospital, whichever occurs first",[13],"Drug: Arginine",{"label":15,"type":10,"description":16,"interventionNames":17},"Loading dose + standard dose","Subjects with sickle cell disease and vaso-occlusive painful events (VOE) will be randomized to receive an intravenous (IV) infusion of an initial loading dose of arginine (200 mg\u002Fkg) given over 30 minutes and then receive an intravenous (IV) infusion of a standard dose of arginine (100 mg\u002Fkg) three times a day for seven days or until discharged from the hospital, whichever occurs first",[13,18],"Drug: Arginine (Loading)",{"label":20,"type":10,"description":21,"interventionNames":22},"Loading dose + continuous infusion","Subjects with sickle cell disease and vaso-occlusive painful events (VOE) will be randomized to receive an intravenous (IV) infusion of an initial loading dose of arginine (200 mg\u002Fkg) given over 30 minutes and then receive a continuous intravenous (IV) infusion of 300 mg\u002Fkg\u002F24hr for 7 days or until discharged from the hospital, whichever occurs first",[18,23],"Drug: Arginine (Continuous)",{"label":25,"type":10,"description":26,"interventionNames":27},"Non-Randomized Loading dose 500 mg\u002Fkg + standard dose","Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) arginine dose at 500 mg\u002Fkg once, followed by a standard dose of 100mg\u002Fkg every 8 hours until discharge or for a total of 21 doses of arginine, whichever comes first.",[18],{"label":29,"type":10,"description":30,"interventionNames":31},"Non-Randomized Loading dose 300 mg\u002Fkg + standard dose","Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) arginine dose at 300 mg\u002Fkg once, followed by a standard dose of 100mg\u002Fkg every 8 hours until discharge or for a total of 21 doses of arginine, whichever comes first.",[18],{"label":33,"type":10,"description":34,"interventionNames":35},"Non-Randomized Loading dose 400mg\u002Fkg + standard dose","Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) arginine dose at 400 mg\u002Fkg once, followed by a standard dose of 100mg\u002Fkg every 8 hours until discharge or for a total of 21 doses of arginine, whichever comes first.",[18],[37,44,49],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":42},"DRUG","Arginine","Arginine will be dispensed intravenously (in the vein) in the standard dose of arginine as 100 mg\u002Fkg three times a day for seven days or until discharge.\n\n* Loading dose: 200 mg\u002Fkg once\n* Continuous IV: 300 mg\u002Fkg\u002F24 hours",[15,9],[43],"Arginine Hydrochloride Injection, R-Gene® 10",{"type":38,"name":45,"description":46,"armGroupLabels":47,"otherNames":48},"Arginine (Loading)","Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) at each specified group dose once, followed by a standard dose of 100mg\u002Fkg every 8 hours until discharge or for a total of 21 doses of arginine, whichever comes first.",[20,15,29,33,25],[43],{"type":38,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Arginine (Continuous)","Arginine will be dispensed intravenously (in the vein) as a continuous IV infusion of 300 mg\u002Fkg\u002F24hr",[20],[43],[55],{"name":56,"affiliation":5,"role":57},"Claudia Morris, MD","PRINCIPAL_INVESTIGATOR",[59,65],{"name":60,"role":61,"phone":62,"phoneExt":63,"email":64},"Reshika Mendis, MBBS","CONTACT","404-785-4525",null,"Reshika.mendis@choa.org",{"name":56,"role":61,"phone":66,"phoneExt":63,"email":67},"404 727-5500","claudia.r.morris@emory.edu",[69,88],{"facility":70,"status":71,"city":72,"state":73,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"Children's Healthcare fo Atlanta at Hughes Spalding","RECRUITING","Atlanta","Georgia","30303","United States","US",{"type":78,"coordinates":79},"Point",[80,81],-84.38798,33.749,{"lat":81,"lon":80},[84],{"name":85,"role":61,"phone":86,"phoneExt":63,"email":87},"Arnetria Dancy","404-778-1873","arnetria.dancy@emory.edu",{"facility":89,"status":71,"city":72,"state":73,"zip":90,"country":75,"countryCode":76,"cosmosGeoPoint":91,"geoPoint":93,"contacts":94},"Children's Healthcare of Atlanta at Arthur M. Blank Hospital","30329",{"type":78,"coordinates":92},[80,81],{"lat":81,"lon":80},[95],{"name":85,"role":61,"phone":86,"phoneExt":63,"email":87},{"type":57,"investigatorFullName":97,"investigatorTitle":98,"investigatorAffiliation":5,"oldNameTitle":63,"oldOrganization":63},"Claudia R. Morris","Professor",[100,102],{"name":101,"class":6},"Children's Healthcare of Atlanta",{"name":103,"class":104},"National Center for Complementary and Integrative Health (NCCIH)","NIH","100243479","phase-1-arginine-therapy-for-the-treatment-of-pain-in-children-with-sickle-cell-disease-100243479",false,"NCT02447874","Arginine Therapy for the Treatment of Pain in Children With Sickle Cell Disease","Arginine Therapy for the Treatment of Vaso-Occlusive Events in Children With Severe Sickle Cell Disease","R34 pK\u002FPD","Inclusion Criteria:\n\n* Established diagnosis of sickle cell disease--Hemoglobin SS (Hb-SS) or Sβᴼ-thalassemia\n* 7-21 years of age\n* Weight \\>= 25kg (55lbs)\n* Pain requiring medical care in an acute care setting (emergency department (ED), hospital ward, day hospital, clinic) requiring parenteral opioids, not attributable to non-sickle cell causes.\n\nExclusion Criteria:\n\n* Decision to discharge home from acute care setting.\n* Diagnosis of sickle cell disease with any of the following types: hemoglobin SC disease (HbSC), hemoglobin beta thalassemia (Hb-Beta Thal), hemoglobin SD disease (HbSD), hemoglobin SE disease (HbSE), hemoglobin SO disease (HbSO), hemoglobin AS carrier (Hb AS)\n* Hemoglobin less than 5 gm\u002FdL\n* Immediate Red cell transfusion anticipated\n* Renal dysfunction: Creatinine \\>1.0 or 2 x baseline\n* Mental status or neurological changes\n* Acute stroke or clinical concern for stroke\n* Pregnancy\n* Allergy to arginine\n* Previous hospitalization \\\u003C 7 days\n* Use of inhaled nitric oxide, sildenafil or arginine within the last 14 days\n* Not an appropriate candidate in the investigator's judgement","ALL","7 Years","21 Years",{"count":117,"type":118},21,"ESTIMATED","INTERVENTIONAL",[121,122],"PHASE1","PHASE2","The purpose of this study is to determine whether giving extra arginine to patients with sickle cell disease seeking treatment for vaso-occlusive painful events (VOE) will decrease pain scores, decrease need for pain medications or decrease length of hospital stay or emergency department visit.",[125],"Sickle Cell Disease","2026-07-27",{"date":128,"type":129},"2026-07-29","ACTUAL",{"date":131,"type":63},"2015-05",{"date":133,"type":118},"2028-01",{"name":5,"class":6},2]