Fungal Otitis Externa (Otomycosis) MedDRA version: 20.0 Level: PT Classification code 10052557 Term: Otitis externa fungal System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: Clotrimazole
Product Code: Clotrimazole 1% Otic Solution
Pharmaceutical Form: Ear drops, solution
INN or Proposed INN: Clotrimazole
CAS Number: 23593-75-1
Other descriptive name: CLOTRIM
Sponsors
Laboratorios Salvat, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • At least 18 years of age at Visit 1 (Day 1, Screening/Baseline). • Clinical diagnosis of fungal otitis externa (otomycosis) in one or both ears, where topical treatment is indicated. • Presence of at least two of the following symptoms at baseline: pruritus, otalgia and ear fullness. • Presence of debris and/or drainage clinically consistent with a fungal infection, i.e. white or black appearance consistent with Aspergillus spp. or Candida spp. • Otorrhea/debris sample for bacterial and mycological cultures. • Provide written informed consent. • Willing and able to follow all instructions and attend all study visits. • Females who are not pregnant, not lactating and are not planning a pregnancy during the study. All females of childbearing potential will be able to participate only if they have a negative urine pregnancy test at baseline and if they agree to use adequate birth control methods to prevent pregnancy throughout the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 191 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 191
Exclusion criteria
Exclusion criteria: • Known bacterial otitis externa or malignant otitis externa. • Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery. • Structural ear anomalies which may difficult the evaluation of the therapeutic response. •Uncontrolled diabetes mellitus. • Known or suspected hypersensitivity to clotrimazole or any component of study medication. • History of an immunosuppressive disorder and/or current immunosuppressive therapy. • History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease condition that contraindicates the use of an investigational drug, might affect the interpretation of the results of the study, or renders the subject at high risk for treatment complications. • Any recent systemic infection within 30 days of the inclusion or any current infection requiring systemic antimicrobial or systemic antifungal therapy. • Use of topical therapy with antifungal properties in the target ear within 2 weeks of the inclusion. • Use of systemic antifungal therapy within 1 month of the inclusion. • Concurrent use of any compound, agent or substance that is applied or instilled to the evaluable ear or surrounding area, except non-bacteriostatic saline solution for potential additional cleaning before taking the sample to be cultured. • Concurrent use of analgesic therapy (prescription or over the counter) with anti-inflammatory properties (acetylsalicylic acid for cardiovascular prevention at doses of 325mg or less is allowed). Analgesics without anti-inflammatory properties, such as acetaminophen and anti-inflammatory agents at stable doses at least 30 days prior to enrollment are allowed. • Concurrent use of non-topical antipruritics, except antihistamines at stable doses (at least 30 days prior to enrollment). • Concurrent use of any systemic corticosteroid, except nasal or inhaled corticosteroids at stable doses (at least 30 days prior to enrollment). • Prior participation in this trial unless patient was not randomized. • Participation in other investigational drug or device clinical trials within 30 days prior to the inclusion, or planning to participate in other investigational drug or device clinical trials within 24 days of starting treatment with study medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the superior efficacy of Clotrimazole vs placebo in the treatment of otomycosis, with respect to the therapeutic cure at test of cure in the MITT population.;Secondary Objective: • Overall clinical outcome at Visits 2, 3 and 4. • Mycological outcome at Visits 2, 3 and 4. • Therapeutic cure at Visit 2 and 3. • Changes in TSSS at Visits 2, 3 and 4. • Changes in individual signs and symptoms at Visits 2, 3 and 4.;Primary end point(s): Therapeutic cure at test-of-cure (Visit 4) in the MITT population.;Timepoint(s) of evaluation of this end point: 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Overall clinical outcome at Visits 2, 3 and 4. • Mycological outcome at Visits 2, 3 and 4. • Therapeutic cure at Visit 2 and 3. • Changes in TSSS at Visits 2, 3 and 4. • Changes in individual signs and symptoms at Visits 2, 3 and 4.;Timepoint(s) of evaluation of this end point: 14 days | — |
Countries
Bulgaria, Portugal, Romania, Spain
Contacts
Public ContactRegulatory
Medpace
Outcome results
None listed