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SVT-15652 Otic Solution for the Treatment of Otomycosis

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ClinicalTrials.gov Identifier: NCT03686384
Recruitment Status : Not yet recruiting
First Posted : September 26, 2018
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Salvat

Brief Summary:
Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.

Condition or disease Intervention/treatment Phase
Otomycosis Drug: SVT-15652 Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 195 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of SVT-15652 Otic Solution Compared to Placebo for the Treatment of Fungal Otitis Externa (Otomycosis)
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : November 2020

Arm Intervention/treatment
Experimental: SVT-15652
1 vial twice daily
Drug: SVT-15652
1 vial twice daily

Placebo Comparator: Placebo
1 vial twice daily
Drug: Placebo
1 vial twice daily




Primary Outcome Measures :
  1. Therapeutical cure [ Time Frame: Test of cure on day 28 ]
    Proportion of subjects with therapeutic cure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Main Inclusion Criteria:

  • At least 18 years of age
  • Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated.
  • Signs/symptoms of pruritus, otalgia and otorrhea.
  • Appearance consistent with fungal debris.

Main 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.
  • Any infection requiring systemic antimicrobial or systemic antifungal therapy.
  • Concomitant medicines that may interfere with the study evaluations.

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Responsible Party: Salvat
ClinicalTrials.gov Identifier: NCT03686384     History of Changes
Other Study ID Numbers: CLEAR-1
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: April 8, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Otomycosis
Mycoses
Ear Diseases
Otorhinolaryngologic Diseases