[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100091323":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":23,"locations":29,"responsibleParty":42,"collaborators":23,"id":45,"slug":46,"hasResults":47,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":23,"eligibilityCriteria":51,"healthyVolunteers":47,"sex":52,"minAge":53,"maxAge":23,"enrollmentInfo":54,"targetDuration":23,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":63,"overallStatus":66,"whyStopped":23,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Optimer Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"1","EXPERIMENTAL","Tablet",[13],"Drug: prulifloxacin",{"label":15,"type":16,"description":11,"interventionNames":17},"2","PLACEBO_COMPARATOR",[13],[19],{"type":20,"name":21,"description":11,"armGroupLabels":22,"otherNames":23},"DRUG","prulifloxacin",[9,15],null,[25],{"name":26,"affiliation":27,"role":28},"Robert Steffen, MD","University of Zurich","STUDY_DIRECTOR",[30],{"facility":31,"status":23,"city":32,"state":33,"zip":23,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":23},"Goa Medical College","Bambolim","Goa","India","IN",{"type":37,"coordinates":38},"Point",[39,40],73.8531,15.46361,{"lat":40,"lon":39},{"type":23,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":43,"oldOrganization":44},"Y.K. Shue","Optimer Pharmaceuticals","100091323","phase-3-safety-and-efficacy-of-prulifloxacin-vs-placebo-in-treatment-of-acute-gastroenteritis-in-adult-travelers-100091323",false,"NCT00448422","Safety and Efficacy of Prulifloxacin vs Placebo in Treatment of Acute Gastroenteritis in Adult Travelers","A Multicenter, Double-Blind, Randomized Study to Compare the Safety and Efficacy of Prulifloxacin Versus Placebo in the Treatment of Acute Gastroenteritis in Adult Travelers","Inclusion Criteria:\n\n* Diagnosis of acute bacterial gastroenteritis\n* Traveler from an industrialized country\n* Capable of giving Informed Consent\n\nExclusion Criteria:\n\n* Fever (\\>100.3 degrees)\n* Pregnant or Breast Feeding or Not using adequate birth control\n* Known or Suspected (co-)Infection with non-bacterial pathogen\n* Symptoms of acute gastroenteritis of \\>72 hours duration\n* Bloody Diarrhea\n* Concomitant antibacterial with activity against enteric bacterial pathogens\n* History of IBD\n* Unable\u002FUnwilling to comply with study protocol\n* Greater than two doses of an antidiarrheal medication within 24 hours\n* \\> 2 doses of anti-diarrheal medication within 24 hours\n* Antimicrobial treatment within 30 days","ALL","18 Years",{"count":55,"type":56},268,"ACTUAL","INTERVENTIONAL",[59],"PHASE3","The objective of this pivotal Phase III study is to investigate the safety and efficacy of prulifloxacin versus placebo in the treatment of patients with acute bacterial gastroenteritis (traveler's diarrhea.",[62],"Acute Bacterial Gastroenteritis",[64,65],"Traveler's","Diarrhea","COMPLETED","2010-09-22",{"date":69,"type":70},"2010-09-27","ESTIMATED",{"date":72,"type":23},"2006-12",{"date":74,"type":56},"2008-08",{"name":5,"class":6},1]