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Trial record 2 of 7 for:    Otomycosis

SVT-15652 Otic Solution for the Treatment of Otomycosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03686384
Recruitment Status : Recruiting
First Posted : September 26, 2018
Last Update Posted : March 19, 2020
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 : 191 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)
Actual Study Start Date : February 27, 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

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 24 ]
    Proportion of subjects with therapeutic cure



Information from the National Library of Medicine

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03686384


Contacts
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Contact: Enrique Jiménez, MD +34 933946400 ejimenzv@svt.com

Locations
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United States, South Carolina
Carolina Ear,Nose and Throat Clinic Recruiting
Orangeburg, South Carolina, United States, 29118
Sponsors and Collaborators
Salvat
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Responsible Party: Salvat
ClinicalTrials.gov Identifier: NCT03686384    
Other Study ID Numbers: CLEAR-1
First Posted: September 26, 2018    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020

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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