Clinical Study to Assess the Efficacy and Safety of G238 Compared to Clotrimazole Otic Solution in the Treatment of Otomycosis
NCT ID: NCT01993823
Last Updated: 2017-04-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
190 participants
INTERVENTIONAL
2013-05-31
2014-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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G238
Five drops into the ear canal twice daily for 14 days
G238
Five drops into the ear canal twice daily for 14 days
Clotrimazole
Five drops into the ear canal twice daily for 14 days
Clotrimazole
Five drops into the ear canal twice daily for 14 days
Interventions
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G238
Five drops into the ear canal twice daily for 14 days
Clotrimazole
Five drops into the ear canal twice daily for 14 days
Eligibility Criteria
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Inclusion Criteria
* Clinical diagnosis of otomycosis where topical treatment is indicated.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Salvat
INDUSTRY
Responsible Party
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Locations
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Laboratorios SALVAT, S.A.
Esplugues de Llobregat, Barcelona, Spain
Countries
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References
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Lee A, Tysome JR, Saeed SR. Topical azole treatments for otomycosis. Cochrane Database Syst Rev. 2021 May 25;5(5):CD009289. doi: 10.1002/14651858.CD009289.pub2.
Other Identifiers
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G238OTIII/11IA01
Identifier Type: -
Identifier Source: org_study_id
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