[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100230147":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":30,"locations":30,"responsibleParty":31,"collaborators":30,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":30,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":42,"enrollmentInfo":43,"targetDuration":30,"studyType":46,"phases":47,"briefSummary":49,"conditions":50,"keywords":30,"overallStatus":52,"whyStopped":30,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":30},{"fullName":5,"class":6},"Apotex Inc.","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Ciclesonide Nasal Spray (Apotex, Inc.)","EXPERIMENTAL","Ciclesonide nasal spray\n\n* Dosage form: contain the aqueous medium of each metered-dose pump spray formulation unit plus the active ingredient, ciclesonide.\n* Strength: 50 μg per actuation.\n* Batch\u002FLot number (Expiry date): JM6697 (May 2012)\n* Manufacturer: Apotex, Inc.",[13],"Drug: Ciclesonide nasal spray, 50 μg per actuation.",{"label":15,"type":16,"description":17,"interventionNames":18},"Omnaris™ nasal spray","ACTIVE_COMPARATOR","Omnaris™ Nasal Spray,\n\n* Dosage form: contain the aqueous medium of each metered-dose pump spray formulation unit plus the active ingredient, ciclesonide\n* Strength: 50 μg per actuation\n* Batch\u002FLot number (Expiry date): 131657 (03\u002F2012)\n* Manufacturer: Sepracor, Inc.",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"Placebo","PLACEBO_COMPARATOR","Placebo\n\n* Dosage form: Contain the aqueous medium of each metered-dose pump spray formulation unit minus the active ingredient, ciclesonide.\n* Batch\u002FLot number (Expiry date): JR3808 (Nov 2012)\n* Manufacturer: Apotex, Inc.",[13],[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","Ciclesonide nasal spray, 50 μg per actuation.","During placebo lead-in period: patients received placebo nasal spray, two actuations in each nostril once daily for 7 days.\n\nDuring treatment period: subjects were then assigned to one of the following three treatments according to the randomization scheme:\n\n1. Ciclesonide nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.\n2. Omnaris™ nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.\n3. Placebo nasal spray: 0 μg per actuation, two actuations in each nostril once daily for 14 days.",[9,15,20],null,{"type":32,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100230147","phase-3-a-study-comparing-the-bioequivalence-of-ciclesonide-nasal-spray-apotex-inc-to-that-of-omnaris-nasal-spray-sepracor-inc-in-the-treatment-of-seasonal-allergic-rhinitis-100230147",false,"NCT02273817","A Study Comparing The Bioequivalence Of Ciclesonide Nasal Spray (Apotex, Inc.) To That Of Omnaris™ Nasal Spray (Sepracor, Inc.) In The Treatment Of Seasonal Allergic Rhinitis","A Randomized, Double-blind, Placebo-controlled, Parallel-group Study Comparing the Bioquivalence of Ciclesonide Nasal Spray(Apotex Inc.) to That of Omnaris ™Nasal Spray (Sepracor, Inc.) in the Treatment of Seasonal Allergic Rhinitis","Inclusion Criteria:\n\n* If female of childbearing potential, is not pregnant (confirmed by negative urine pregnancy test) or lactating and must have used reliable birth control measures throughout the study.\n* At least a 2-year reliable medical history consistent with SAR\n* Positive skin test within 12 months of screening to at least one seasonal allergen present in the geographical area\n* Capable of tolerating intranasal application of the IMP, willing and able to comply with the requirements of the protocol\n* No clinically significant findings in physical and nasal examinations, and medical history.\n* A reflective TNSS of at least 6 (out of 12) in the 24 hours prior to placebo lead-in visit.\n* Successfully complete the placebo lead-in period.\n\nExclusion Criteria:\n\n* \\- Signs or symptoms of nasal polyps, deviated septum, or any other condition which, in the opinion of the Investigator, could resulted in erroneous study data.\n* Undergo nasal surgery or had nasal trauma within 3 months of screening.\n* Active respiratory conditions or respiratory tract infection that require antibiotic treatment within 2 weeks of screening\n* Persistent allergic rhinitis (PAR) that does not require or not expected to require active PAR treatment during the study period.\n* Evidence of any unstable or clinically significant conditions that would place the subject at increased risk of complications, interfere with study participation, or confound any of the study objectives.\n* Presence or history of clinically significant conditions which in the opinion of the Investigator would have compromised the safety of the subject or the conduct of the study.\n* Use of corticosteroids, intranasal cromolyn, Leukotriene inhibitors, long or short acting antihistamines, intranasal or systemic decongestants prior to the start of the single-blind, placebo lead-in visit within the time periods specified in the protocol or receiving immunotherapy.\n* Use of an investigational drug within 30 days before screening or during the study.\n* Known or suspected hypersensitivity to corticosteroids.\n* Inability to avoid exposure to chicken pox or measles.\n* Infection requiring oral antibiotic treatment 2 weeks prior to screening.\n* Previously identified as a placebo responder or known as a non responder to corticosteroids.\n* History of alcohol, drug, or substance abuse in the 12 months prior to Visit 1 (screening).\n* Positive for hepatitis B or C, or human immunodeficiency virus (HIV).\n* Uncooperative or non compliant.\n* Female subjects who planned to become pregnant during the conduct of the study.\n* Current smoker (former smokers had to be 6 months smoke free).","ALL","18 Years","65 Years",{"count":44,"type":45},580,"ACTUAL","INTERVENTIONAL",[48],"PHASE3","This study is to evaluate the equivalence of generic ciclesonide nasal spray with that of the marketed drug, Omnaris™ nasal spray, in the treatment of seasonal allergic rhinitis, and to evaluate the safety and tolerability of generic ciclesonide nasal spray compared with Omnaris™ nasal spray.",[51],"Seasonal Allergic Rhinitis","COMPLETED","2014-10-23",{"date":55,"type":56},"2014-10-24","ESTIMATED",{"date":58,"type":30},"2011-03",{"date":60,"type":45},"2011-08",{"name":5,"class":6}]