Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT00945802
Status:
TERMINATED
Last Update Posted:
2021-05-27
First Post:
2009-07-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FST-201 In The Treatment of Acute Otitis Externa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002939', 'term': 'Ciprofloxacin'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'dispFirstSubmitDate': '2012-09-05', 'completionDateStruct': {'date': '2010-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-24', 'studyFirstSubmitDate': '2009-07-23', 'dispFirstSubmitQcDate': '2012-09-05', 'studyFirstSubmitQcDate': '2009-07-23', 'dispFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2021-05-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-07-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria.', 'timeFrame': '1 year'}]}, 'conditionsModule': {'conditions': ['Acute Otitis Externa']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have a clinical diagnosis of AOE in one or both ears, defined as a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1).\n* Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race.\n* Provide written informed consent or parental assent.\n* Be willing and able to follow all instructions and attend all study visits\n\nExclusion Criteria:\n\nAll subjects must not:\n\n* Have known sensitivity to any component of the study medications\n* Have a current infection requiring systemic antimicrobial treatment\n* Have used topical or systemic pain meds on the same day as Screening/Baseline Visit 1 and for the duration of the study.\n* Take any systemic (within 30 days) or otic corticosteroids (within 1 days) prior to Screening/Baseline Visit 1\n* Current use of topical or systemic non-steroidal or other anti-inflammatory drugs.\n* Use any topical otic treatment with alcohol, vinegar, hydrogen peroxide or other astringent medication during the course of the study or on the same day as Screening/Baseline Visit 1\n* Have taken any antibiotics within 3 days prior to Visit 1\n* Have signs and symptoms of AOE for \\> 4 weeks at Screening/Baseline Visit 1\n* Have a non-intact or perforated tympanic membrane in the enrolled ear\n* Have a clinical diagnosis of chronic suppurative otitis media, acute otitis media or acute otorrhea in patients with tympanostomy tubes\n* Have a clinical diagnosis of malignant otitis externa\n* Have overt fungal AOE\n* Have a viral infection of the pinna or tympanic membrane (i.e herpes zoster)\n* Have congenital abnormalities of the external auditory canal in the enrolled ear(s)\n* Have obstructive bony exostoses in the enrolled ear(s)\n* Have mastoid or other suppurative, non-infectious ear disorders (e.g, cholesteatoma)\n* Have malignant tumors of the external auditory canal\n* Have a history of otologic surgery. Surgery performed more than 1 year prior to Screening/Baseline Visit 1and limited to the tympanic membrane is allowed\n* Have seborrheic dermatitis of the external auditory canal\n* Have a current or prior history of immunosuppressive disorders\n* Have acute or chronic renal insufficiency, hepatitis or diabetes mellitus\n* Be pregnant, nursing or planning a pregnancy.'}, 'identificationModule': {'nctId': 'NCT00945802', 'briefTitle': 'FST-201 In The Treatment of Acute Otitis Externa', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'A Multi-Center, Randomized, Double-Masked Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex (Ciprofloxacin 0.3%, Dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, Inc.) in Subjects With Acute Otitis Externa', 'orgStudyIdInfo': {'id': 'FST201-AOE-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FST-201 (dexamethasone 0.1%) Otic Suspension', 'interventionNames': ['Drug: FST-201 (dexamethasone 0.1%) Otic Suspension']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ciprofloxacin 0.3%, dexamethasone 0.1%', 'interventionNames': ['Drug: ciprofloxacin 0.3%, dexamethasone 0.1%']}], 'interventions': [{'name': 'FST-201 (dexamethasone 0.1%) Otic Suspension', 'type': 'DRUG', 'description': 'Instill four drops two times a day', 'armGroupLabels': ['FST-201 (dexamethasone 0.1%) Otic Suspension']}, {'name': 'ciprofloxacin 0.3%, dexamethasone 0.1%', 'type': 'DRUG', 'otherNames': ['Ciprodex'], 'description': 'Instill four drops two times a day', 'armGroupLabels': ['ciprofloxacin 0.3%, dexamethasone 0.1%']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33426', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'ENT Associates of South Florida', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Ear, Nose, and Throat Clinic', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '78215', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Ear, Nose, and Throat Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'San Antonio Ear, Nose, and Throat Research', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Ear Institute of Texas', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Study Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shire', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}