[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100204453":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":40,"centralContacts":31,"locations":31,"responsibleParty":44,"collaborators":31,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":31,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":31,"enrollmentInfo":55,"targetDuration":31,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":64,"overallStatus":72,"whyStopped":31,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":31},{"fullName":5,"class":6},"Pfizer","INDUSTRY",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment A","EXPERIMENTAL","IBU 200 mg\u002F PE 10 mg",[13],"Drug: Advil Congestion Relief",{"label":15,"type":10,"description":16,"interventionNames":17},"Treatment B","IBU 200 mg\u002F PE 10 mg\u002FCHLOR 4 mg",[18],"Drug: Advil Allergy and Congestion Relief",{"label":20,"type":21,"description":22,"interventionNames":23},"Treatment C","ACTIVE_COMPARATOR","Acetaminophen 500 mg",[24],"Drug: Paracetamol",[26,32,36],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DRUG","Advil Congestion Relief","Orally adminstered, 200 mg Ibuprofen\u002F10 mg Phenylephrine tablet, 4x\u002Fday, up to 8 doses.",[9],null,{"type":27,"name":33,"description":34,"armGroupLabels":35,"otherNames":31},"Advil Allergy and Congestion Relief","Orally adminstered, 200 mg Ibuprofen\u002F10 mg Phenylephrine\u002F4 mg Chlorpheniramine tablet, 4x\u002Fday, up to 8 doses.",[15],{"type":27,"name":37,"description":38,"armGroupLabels":39,"otherNames":31},"Paracetamol","Acetaminophen 500 mg, 4x\u002Fday, up to 8 doses.",[20],[41],{"name":42,"affiliation":5,"role":43},"Pfizer CT.gov Call Center","STUDY_DIRECTOR",{"type":45,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100204453","phase-3-evaluation-of-the-efficacy-and-safety-of-two-ibuprofen-combination-products-for-the-treatment-of-the-common-cold-and-flu-in-latin-america-100204453",false,"NCT01938144","Evaluation of the Efficacy and Safety of Two Ibuprofen Combination Products for the Treatment of the Common Cold and Flu in Latin America","Three-day Clinical Evaluation Of The Efficacy And Safety Of Two Ibuprofen Combination Products For The Symptomatic Treatment Of The Common Cold And Flu: A Multicenter Study","Inclusion Criteria:\n\nMale and female subjects who are 18 years old or older at the time of screening.\n\nSubjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.\n\nSubjects must present with a score of 5 of higher for at least 2 of the following 6 symptoms: runny nose, plugged nose, sneezing, sore throat, scratchy throat, or head congestion on the WURSS-21 assessment, within 36 hours of onset of symptoms.\n\nExclusion Criteria:\n\nAnyone with a history of chronic allergic rhinitis or asthma at the time of the screening visit, or with history of chronic recurrent airway disease, infections, or frequent complications of colds (otitis media, sinusitis, or bronchitis)\n\nSubjects taking any prescription or non-prescription drug, within the last 7 days prior to the screening, with which the administration of IBU, PE, CHLOR, or APAP is contraindicated, may increase the risk associated with study participation, or may interfere with the interpretation of study results, in the judgment of the Investigator.\n\nSubjects currently taking a monoamine oxidase (MAO) inhibitor, or has taken an MAO inhibitor within 2 months of screening.\n\nSubjects currently taking a serotonin-selective reuptake inhibitor (SSRI), tricyclic antidepressant (TCA), barbiturate, or any other neuroleptic, or has taken an SSRI, TCA, barbiturate, or any other neuroleptic within 14 days of screening.\n\nSubjects with a hypersensitivity to IBU, PE, or CHLOR or APAP.","ALL","18 Years",{"count":56,"type":57},0,"ACTUAL","INTERVENTIONAL",[60],"PHASE3","This is a multicenter, prospective, randomized, double-blind, triple-dummy, parallel group, comparative, study designed to evaluate the efficacy of Ibuprofen (IBU) 200 mg\u002F Phenylephrine (PE) 10 mg and IBU 200 mg\u002F PE 10 mg\u002F Chlorpheniramine (CHLOR) 4 mg on the relief of symptoms of the common cold and flu. The reference product that the active treatments will be compared to is paracetamol (PARA) 500 mg.",[63],"Common Cold",[65,66,67,68,69,70,71],"Common cold","efficacy","symptoms","Wisconsin Upper Respiratory Symptom Survey - 21","ibuprofen","phenylephrine","pseudoephedrine","WITHDRAWN","2015-10-13",{"date":75,"type":76},"2015-10-14","ESTIMATED",{"date":78,"type":31},"2016-04",{"date":80,"type":76},"2016-11",{"name":5,"class":6}]