E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Fungal Otitis Externa (Otomycosis) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10052557 |
E.1.2 | Term | Otitis externa fungal |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
• 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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
Therapeutic cure at test-of-cure (Visit 4) in the MITT population.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | 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.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |