SVT-15652 Otic Solution for the Treatment of Otomycosis.
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).
1 other identifier
interventional
194
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 20, 2018
CompletedFirst Posted
Study publicly available on registry
September 26, 2018
CompletedStudy Start
First participant enrolled
June 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2021
CompletedResults Posted
Study results publicly available
December 15, 2022
CompletedDecember 15, 2022
November 1, 2022
1.4 years
September 20, 2018
October 26, 2022
November 21, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Therapeutic Cure (Clinical and Mycological Cure)
Percentage of subjects with therapeutic cure
Test of cure on day 24
Study Arms (2)
SVT-15652
EXPERIMENTAL1 vial twice daily
Placebo
PLACEBO COMPARATOR1 vial twice daily
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Salvatlead
Study Sites (1)
Hospital Clinic
Barcelona, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Director
- Organization
- Laboratorios Salvat, S.A
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 20, 2018
First Posted
September 26, 2018
Study Start
June 9, 2020
Primary Completion
October 19, 2021
Study Completion
October 19, 2021
Last Updated
December 15, 2022
Results First Posted
December 15, 2022
Record last verified: 2022-11