Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-03-01 @ 8:59 PM
Study NCT ID:
NCT01518920
Status:
COMPLETED
Last Update Posted:
2019-11-21
First Post:
2012-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006319', 'term': 'Hearing Loss, Sensorineural'}], 'ancestors': [{'id': 'D034381', 'term': 'Hearing Loss'}, {'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000600968', 'term': 'PF-04958242'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2012-01-23', 'studyFirstSubmitQcDate': '2012-01-23', 'lastUpdatePostDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-01-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline to 1 hour post-dose in pure tone audiometry averaged over 2 and 4 kHz', 'timeFrame': '1 hour'}], 'secondaryOutcomes': [{'measure': 'Change from baseline to 5 hours post-dose in pure tone audiometry averaged over 2 and 4 kHz', 'timeFrame': '5 hours'}, {'measure': 'Change from baseline to 1 hr and 5 hrs post-dose in Speech Discrimination Score', 'timeFrame': '1 hour, 5 hours'}, {'measure': 'Change from baseline to 1 hr and 5 hrs post dose in Speech In Noise Testing', 'timeFrame': '1 hour, 5 hours'}, {'measure': 'Change from baseline to 1 hr and 5 hrs post dose in Tinnitus Severity Ranking Scale', 'timeFrame': '1 hour, 5 hours'}, {'measure': 'Plasma PF 04958242 concentrations at 45 min post dose and following endpoint assessments at 1 and 5 hrs post dose.', 'timeFrame': '45 min, 1 hour, 5 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Age related sensorineural hearing loss', 'PF-04958242'], 'conditions': ['Hearing Loss, Sensorineural']}, 'referencesModule': {'references': [{'pmid': '25997115', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': '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', 'label': 'To obtain contact information for a study center near you, click here.'}]}, '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects 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.\n* Subjects must have symmetric hearing loss\n* Subjects who can read, speak and comprehend English.\n\nExclusion Criteria:\n\n* Subjects who have a history of sudden hearing loss and history or diagnosis of rapidly progressive idiopathic hearing loss\n* Subjects who have hearing disorders other than age related sensorineural hearing loss\n* Subjects with moderate or greater tinnitus\n* Pregnant females; breastfeeding females; females of childbearing potential'}, 'identificationModule': {'nctId': 'NCT01518920', 'briefTitle': 'A Study Of The Effects Of PF-04958242 In Subjects With Age-Related Hearing Loss', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, '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', 'orgStudyIdInfo': {'id': 'B1701005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PF-04958242', 'interventionNames': ['Drug: PF-04958242']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'PF-04958242', 'type': 'DRUG', 'description': 'PF-04958242 0.35 mg oral solution', 'armGroupLabels': ['PF-04958242']}, {'name': 'PF-04958242', 'type': 'DRUG', 'description': 'PF-04958242 0.27 mg oral solution', 'armGroupLabels': ['PF-04958242']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo oral solution', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06519', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06520-8071', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33143', 'city': 'South Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 25.7076, 'lon': -80.29338}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '75390-8575', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390-8868', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390-8891', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75390-9035', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Biogen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}