{ "FullStudy":{ "Rank":217628, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01518920", "OrgStudyIdInfo":{ "OrgStudyId":"B1701005" }, "Organization":{ "OrgFullName":"Biogen", "OrgClass":"INDUSTRY" }, "BriefTitle":"A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss", "OfficialTitle":"A Double-Blind, Randomized, Placebo-Controlled, Single-Dose, Crossover Study Of The Safety And Efficacy Of Two Fixed Doses Of PF-04958242 In Subjects With Age-Related Sensorineural Hearing Loss" }, "StatusModule":{ "StatusVerifiedDate":"November 2019", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"December 2011" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2013", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2013", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 23, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 26, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"November 19, 2019", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"November 21, 2019", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Biogen", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The objective of this study is to examine the safety, tolerability, and effects on hearing thresholds of two single doses of PF-04958242 and placebo in subjects with age-related hearing loss.", "DetailedDescription":"This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Hearing Loss, Sensorineural" ] }, "KeywordList":{ "Keyword":[ "Age related sensorineural hearing loss", "PF-04958242" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 1" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Crossover Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"44", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"PF-04958242", "ArmGroupType":"Experimental", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: PF-04958242" ] } },{ "ArmGroupLabel":"Placebo", "ArmGroupType":"Placebo Comparator", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"PF-04958242", "InterventionDescription":"PF-04958242 0.35 mg oral solution", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PF-04958242" ] } },{ "InterventionType":"Drug", "InterventionName":"PF-04958242", "InterventionDescription":"PF-04958242 0.27 mg oral solution", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "PF-04958242" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo", "InterventionDescription":"Placebo oral solution", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz", "PrimaryOutcomeTimeFrame":"1 hour" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz", "SecondaryOutcomeTimeFrame":"5 hours" },{ "SecondaryOutcomeMeasure":"Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score", "SecondaryOutcomeTimeFrame":"1 hour, 5 hours" },{ "SecondaryOutcomeMeasure":"Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing", "SecondaryOutcomeTimeFrame":"1 hour, 5 hours" },{ "SecondaryOutcomeMeasure":"Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale", "SecondaryOutcomeTimeFrame":"1 hour, 5 hours" },{ "SecondaryOutcomeMeasure":"Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose.", "SecondaryOutcomeTimeFrame":"45 min, 1 hour, 5 hours" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nSubjects must have a current diagnosis of age related sensorineural hearing loss in the range of 30-60 dB, averaged over 2 and 4 kHz in at least one ear.\nSubjects must have symmetric hearing loss\nSubjects who can read, speak and comprehend English.\n\nExclusion Criteria:\n\nSubjects who have a history of sudden hearing loss and history or diagnosis of rapidly progressive idiopathic hearing loss\nSubjects who have hearing disorders other than age related sensorineural hearing loss\nSubjects with moderate or greater tinnitus\nPregnant females; breastfeeding females; females of childbearing potential", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"50 Years", "MaximumAge":"75 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Medical Director", "OverallOfficialAffiliation":"Biogen", "OverallOfficialRole":"Study Director" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Pfizer Investigational Site", "LocationCity":"Anaheim", "LocationState":"California", "LocationZip":"92801", "LocationCountry":"United States" },{ "LocationFacility":"Pfizer Investigational Site", "LocationCity":"New Haven", "LocationState":"Connecticut", "LocationZip":"06510", "LocationCountry":"United States" },{ "LocationFacility":"Pfizer Investigational Site", "LocationCity":"New Haven", "LocationState":"Connecticut", "LocationZip":"06511", "LocationCountry":"United States" },{ "LocationFacility":"Pfizer Investigational Site", "LocationCity":"New Haven", "LocationState":"Connecticut", "LocationZip":"06519", "LocationCountry":"United States" },{ "LocationFacility":"Pfizer Investigational Site", "LocationCity":"New Haven", "LocationState":"Connecticut", "LocationZip":"06520-8071", "LocationCountry":"United States" },{ "LocationFacility":"Pfizer Investigational Site", "LocationCity":"South Miami", "LocationState":"Florida", "LocationZip":"33143", "LocationCountry":"United States" },{ "LocationFacility":"Pfizer Investigational Site", "LocationCity":"Baltimore", "LocationState":"Maryland", "LocationZip":"21287", "LocationCountry":"United States" },{ "LocationFacility":"Pfizer Investigational Site", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75390-8575", "LocationCountry":"United States" },{ "LocationFacility":"Pfizer Investigational Site", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75390-8868", "LocationCountry":"United States" },{ "LocationFacility":"Pfizer Investigational Site", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75390-8891", "LocationCountry":"United States" },{ "LocationFacility":"Pfizer Investigational Site", "LocationCity":"Dallas", "LocationState":"Texas", "LocationZip":"75390-9035", "LocationCountry":"United States" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"25997115", "ReferenceType":"derived", "ReferenceCitation":"Bednar MM, DeMartinis N, Banerjee A, Bowditch S, Gaudreault F, Zumpano L, Lin FR. The Safety and Efficacy of PF-04958242 in Age-Related Sensorineural Hearing Loss: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2015 Jul;141(7):607-13. doi: 10.1001/jamaoto.2015.0791." } ] }, "SeeAlsoLinkList":{ "SeeAlsoLink":[ { "SeeAlsoLinkLabel":"To obtain contact information for a study center near you, click here.", "SeeAlsoLinkURL":"https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1701005&StudyName=A%20Study%20Of%20The%20Effects%20Of%20PF-04958242%20In%20Subjects%20With%20Age-Related%20Hearing%20Loss" } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000034381", "ConditionMeshTerm":"Hearing Loss" },{ "ConditionMeshId":"D000003638", "ConditionMeshTerm":"Deafness" },{ "ConditionMeshId":"D000006319", "ConditionMeshTerm":"Hearing Loss, Sensorineural" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000006311", "ConditionAncestorTerm":"Hearing Disorders" },{ "ConditionAncestorId":"D000004427", "ConditionAncestorTerm":"Ear Diseases" },{ "ConditionAncestorId":"D000010038", "ConditionAncestorTerm":"Otorhinolaryngologic Diseases" },{ "ConditionAncestorId":"D000012678", "ConditionAncestorTerm":"Sensation Disorders" },{ "ConditionAncestorId":"D000009461", "ConditionAncestorTerm":"Neurologic Manifestations" },{ "ConditionAncestorId":"D000009422", "ConditionAncestorTerm":"Nervous System Diseases" },{ "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M23007", "ConditionBrowseLeafName":"Hearing Loss", "ConditionBrowseLeafAsFound":"Hearing Loss", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M7990", "ConditionBrowseLeafName":"Hearing Loss, Sensorineural", "ConditionBrowseLeafAsFound":"Hearing Loss, Sensorineural", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5423", "ConditionBrowseLeafName":"Deafness", "ConditionBrowseLeafAsFound":"Hearing Loss", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M12761", "ConditionBrowseLeafName":"Presbycusis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7983", "ConditionBrowseLeafName":"Hearing Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M6184", "ConditionBrowseLeafName":"Ear Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M11544", "ConditionBrowseLeafName":"Otorhinolaryngologic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M14073", "ConditionBrowseLeafName":"Sensation Disorders", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M10987", "ConditionBrowseLeafName":"Neurologic Manifestations", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC09", "ConditionBrowseBranchName":"Ear, Nose, and Throat Diseases" },{ "ConditionBrowseBranchAbbrev":"BC10", "ConditionBrowseBranchName":"Nervous System Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" } ] } } } } } }