A Phase 3 interventional study of SVT-15652 and Placebo in Otomycosis, sponsored by Salvat. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-03.
Sponsored by Salvat · Phase 3, Interventional, and Treatment
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.
Salvat is the lead sponsor of 12 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Main Inclusion Criteria:
Main Exclusion Criteria:
1 vial twice daily
Drug: SVT-15652
1 vial twice daily
Drug: Placebo
1 vial twice daily
1 vial twice daily
Therapeutical Cure (Clinical and Mycological Cure)
Number and percentage of subjects with therapeutic cure
Time frame: Test of cure on day 24
The principal investigator was an otolaryngologist
| Milestone | SVT-15652 | Placebo |
|---|---|---|
| Started | 82 | 36 |
| Completed | 75 | 21 |
| Not completed | 7 | 15 |
| Withdrew: Lack of efficacy | 4 | 13 |
| Withdrew: Lost to follow-up | 3 | 0 |
| Withdrew: Physician decision | 0 | 1 |
| Withdrew: Took prohibited medication | 0 | 1 |
Number and percentage of subjects with therapeutic cure
| Participants | SVT-15652 | Placebo |
|---|---|---|
| Therapeutical Cure (Clinical and Mycological Cure) | 48 | 10 |
Collected over Overall study (about 4 weeks). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SVT-15652 | 0/134 (0%) | 0/134 (0%) | 5/134 (3.7%) |
| Placebo | 0/68 (0%) | 0/68 (0%) | 4/68 (5.9%) |
| Event | SVT-15652 | Placebo |
|---|---|---|
| Ear painEar and labyrinth disorders | 2/134 | 2/68 |
| HeadacheNervous system disorders | 3/134 | 2/68 |
MITT Population: Randomized patients who had posititve baseline fungal culture for Aspergillus spp and/or Candida spp
| Age, Continuous(years) | SVT-15652 | Placebo | Total |
|---|---|---|---|
| Mean | 53.0 ± 17.53 | 53.4 ± 19.91 | 53.1 ± 18.20 |
| Sex: Female, Male(Participants) | SVT-15652 | Placebo | Total |
|---|---|---|---|
| Female | 40 | 15 | 55 |
| Male | 42 | 21 | 63 |
| Race (NIH/OMB)(Participants) | SVT-15652 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 4 | 1 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 9 | 4 | 13 |
| White | 63 | 26 | 89 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 4 | 3 | 7 |
| Region of Enrollment(participants) | SVT-15652 | Placebo | Total |
|---|---|---|---|
| United States | 76 | 32 | 108 |
| Mexico | 6 | 4 | 10 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2020 to primary completion in Oct 2021, 19 months.
Results were first posted in Jan 2023, 1 year 2 months after primary completion.
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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Clotrimazole
Otomycosis
Salvat