[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100103686":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":25,"locations":33,"responsibleParty":47,"collaborators":25,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":57,"sex":58,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":25,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":25,"overallStatus":74,"whyStopped":25,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},{"fullName":5,"class":6},"Amgen","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"HZT-501","EXPERIMENTAL","HZT-501: ibuprofen 800mg\u002Ffamotidine 26.6mg",[13],"Drug: HZT-501",{"label":15,"type":16,"description":17,"interventionNames":18},"Ibuprofen","ACTIVE_COMPARATOR","Ibuprofen 800mg",[19],"Drug: Ibuprofen",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Ibuprofen 800mg\u002Ffamotidine 26.6 mg administered orally 3 times daily for 2 weeks",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Ibuprofen 800mg administered orally 3 times daily for at least 28 weeks",[15],[30],{"name":31,"affiliation":5,"role":32},"MD","STUDY_DIRECTOR",[34],{"facility":35,"status":25,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":25},"PRA International","San Diego","California","92122","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-117.16472,32.71571,{"lat":45,"lon":44},{"type":48,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100103686","phase-3-double-blind-follow-on-safety-study-of-hzt-501-ibuprofen-800-mgfamotidine-266-mg-in-subjects-who-have-completed-participation-in-hz-ca-301-nct00450658-or-hz-ca-303-nct00450216-100103686",true,"NCT00613106","Double-Blind Follow-on Safety Study of HZT-501 (Ibuprofen 800 mg\u002FFamotidine 26.6 mg) in Subjects Who Have Completed Participation in HZ-CA-301 (NCT00450658) or HZ-CA-303 (NCT00450216)","Double-Blind Follow-On Safety Study of HZT-501 (Ibuprofen 800 mg\u002FFamotidine 26.6 mg)in Subjects Who Have Completed Participation in Horizon Protocol HZ-CA-301 (NCT00450658)or Horizon Protocol HZ-CA-303 (NCT00450216)","HZ-CA-304","Inclusion Criteria:\n\n* Expected to continue to require daily administration of an NSAID for at least the coming 6 months.\n* Subject completed the 24-week Treatment period of either Horizon Protocol HZ-CA-301 or HZ-CA-303\n\nExclusion Criteria:\n\n* Subject didn't meet all of the Inclusion and Exclusion Criteria for Horizon Protocol HZ-CA-301 or HZ-CA-303\n* Subject developed or experienced any of the following while on either HZ-CA-301 or HZ-CA-303\n* Malignant Disease of the gastrointestinal tract\n* Erosive esophagitis\n* Clinically significant cardiac, renal or hepatic disease\n* Uncontrolled diabetes\n* Positive pregnancy test on Study Day 0\n* Please note that there are other additional criteria. The study center will determine if you meet all of the criteria.",false,"ALL","40 Years","81 Years",{"count":62,"type":63},179,"ACTUAL","INTERVENTIONAL",[66],"PHASE3","The purpose of this study is to evaluate the safety of long-term treatment with HZT-501.",[69,70,71,72,73],"Osteoarthritis","Rheumatoid Arthritis","Chronic Low Back Pain","Chronic Regional Pain Syndrome","Chronic Soft Tissue Pain","COMPLETED","2024-11-21",{"date":77,"type":63},"2024-12-17",{"date":79,"type":25},"2007-09",{"date":81,"type":63},"2008-10",{"name":5,"class":6},1]