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SVT-15652 Otic Solution for the Treatment of Otomycosis.

NCT ID: NCT03686397

Last Updated: 2022-12-15

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

194 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-09

Study Completion Date

2021-10-19

Brief Summary

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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.

Detailed Description

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Conditions

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Otomycosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SVT-15652

1 vial twice daily

Group Type EXPERIMENTAL

SVT-15652

Intervention Type DRUG

1 vial twice daily

Placebo

1 vial twice daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

1 vial twice daily

Interventions

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SVT-15652

1 vial twice daily

Intervention Type DRUG

Placebo

1 vial twice daily

Intervention Type DRUG

Other Intervention Names

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SVT-15652 Otic Solution

Eligibility Criteria

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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 ear fullness.
* Debris or drainage clinically consistent with fungal infection.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Salvat

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Clinic

Barcelona, , Spain

Site Status

Countries

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Spain

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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CLEAR-2

Identifier Type: -

Identifier Source: org_study_id