Nctid:
NCT00000363
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-09-05"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000010031", "term"=>"Otitis"}, {"id"=>"D000010033", "term"=>"Otitis Media"}], "ancestors"=>[{"id"=>"D000004427", "term"=>"Ear Diseases"}, {"id"=>"D000010038", "term"=>"Otorhinolaryngologic Diseases"}], "browseLeaves"=>[{"id"=>"M12954", "name"=>"Otitis", "asFound"=>"Otitis", "relevance"=>"HIGH"}, {"id"=>"M12956", "name"=>"Otitis Media", "asFound"=>"Otitis Media", "relevance"=>"HIGH"}, {"id"=>"M7601", "name"=>"Ear Diseases", "relevance"=>"LOW"}, {"id"=>"M12961", "name"=>"Otorhinolaryngologic Diseases", "relevance"=>"LOW"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Ear, Nose, and Throat Diseases", "abbrev"=>"BC09"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000006633", "term"=>"Histamine Antagonists"}, {"id"=>"D000006634", "term"=>"Histamine H1 Antagonists"}], "ancestors"=>[{"id"=>"D000018494", "term"=>"Histamine Agents"}, {"id"=>"D000018377", "term"=>"Neurotransmitter Agents"}, {"id"=>"D000045504", "term"=>"Molecular Mechanisms of Pharmacological Action"}, {"id"=>"D000045505", "term"=>"Physiological Effects of Drugs"}], "browseLeaves"=>[{"id"=>"M4222", "name"=>"Anti-Bacterial Agents", "relevance"=>"LOW"}, {"id"=>"M7992", "name"=>"Epinephrine", "relevance"=>"LOW"}, {"id"=>"M30371", "name"=>"Racepinephrine", "relevance"=>"LOW"}, {"id"=>"M211043", "name"=>"Epinephryl borate", "relevance"=>"LOW"}, {"id"=>"M9789", "name"=>"Hormones", "relevance"=>"LOW"}, {"id"=>"M4224", "name"=>"Antibiotics, Antitubercular", "relevance"=>"LOW"}, {"id"=>"M9708", "name"=>"Histamine", "relevance"=>"LOW"}, {"id"=>"M9709", "name"=>"Histamine Antagonists", "asFound"=>"Benzoyl Peroxide", "relevance"=>"HIGH"}, {"id"=>"M9710", "name"=>"Histamine H1 Antagonists", "asFound"=>"Benzoyl Peroxide", "relevance"=>"HIGH"}, {"id"=>"M212144", "name"=>"Histamine phosphate", "relevance"=>"LOW"}, {"id"=>"M20504", "name"=>"Neurotransmitter Agents", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Anti-Infective Agents", "abbrev"=>"Infe"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Vasoconstrictor Agents", "abbrev"=>"VaCoAg"}, {"name"=>"Respiratory System Agents", "abbrev"=>"Resp"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["PHASE3"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"DOUBLE"}, "primaryPurpose"=>"TREATMENT"}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2006-04", "completionDateStruct"=>{"date"=>"2001-06"}, "lastUpdateSubmitDate"=>"2006-04-21", "studyFirstSubmitDate"=>"1999-11-02", "studyFirstSubmitQcDate"=>"1999-11-02", "lastUpdatePostDateStruct"=>{"date"=>"2006-04-24", "type"=>"ESTIMATED"}, "studyFirstPostDateStruct"=>{"date"=>"1999-11-03", "type"=>"ESTIMATED"}}, "conditionsModule"=>{"keywords"=>["Antibiotics", "Adrenal Cortex Hormones", "Histamine H1 Antagonists", "Infant", "Otitis Media"], "conditions"=>["Otitis Media"]}, "referencesModule"=>{"references"=>[{"pmid"=>"14517524", "type"=>"BACKGROUND", "citation"=>"Chonmaitree T, Saeed K, Uchida T, Heikkinen T, Baldwin CD, Freeman DH Jr, McCormick DP. A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media. J Pediatr. 2003 Sep;143(3):377-85. doi: 10.1067/S0022-3476(03)00293-2."}, {"pmid"=>"12633920", "type"=>"BACKGROUND", "citation"=>"McCormick DP, Saeed K, Uchida T, Baldwin CD, Deskin R, Lett-Brown MA, Heikkinen T, Chonmaitree T. Middle ear fluid histamine and leukotriene B4 in acute otitis media: effect of antihistamine or corticosteroid treatment. Int J Pediatr Otorhinolaryngol. 2003 Mar;67(3):221-30. doi: 10.1016/s0165-5876(02)00372-5."}]}, "descriptionModule"=>{"briefSummary"=>"Acute otitis media is one of the most common diseases of childhood and is one of the major causes of hearing loss in children. Despite the availability of effective antibiotic therapy for otitis media, treatment failures, persistent effusions, and recurrences are common. This Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes of patients with acute otitis media. This study is targeted to recruiting 200 infants (age less than one year); patient (and parent) participation is estimated to continue for one year after enrollment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"1 year", "minimumAge"=>"2 months", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Have had two documented prior episodes of acute otitis media.\n* Have no current middle ear effusion (fluid).\n\nExclusion Criteria:\n\n* Have chronic otitis media.\n* Have acute otitis media in addition to chronic otitis media."}, "identificationModule"=>{"nctId"=>"NCT00000363", "briefTitle"=>"Acute Otitis Media: Adjuvant Therapy to Improve Outcome", "organization"=>{"class"=>"NIH", "fullName"=>"National Institute on Deafness and Other Communication Disorders (NIDCD)"}, "orgStudyIdInfo"=>{"id"=>"NIDCD-1160"}, "secondaryIdInfos"=>[{"id"=>"R01DC002620-04", "link"=>"https://reporter.nih.gov/quickSearch/R01DC002620-04", "type"=>"NIH"}]}, "armsInterventionsModule"=>{"interventions"=>[{"name"=>"Antihistamine", "type"=>"DRUG"}, {"name"=>"Corticosteroid", "type"=>"DRUG"}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"77550", "city"=>"Galveston", "state"=>"Texas", "country"=>"United States", "facility"=>"Univ of Texas Med Branch Children's Hosp", "geoPoint"=>{"lat"=>29.30135, "lon"=>-94.7977}}], "overallOfficials"=>[{"name"=>"Dr. Tasnee Chonmaitree", "role"=>"STUDY_CHAIR"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"National Institute on Deafness and Other Communication Disorders (NIDCD)", "class"=>"NIH"}}}}
