A Phase 3 interventional study of SVT-15652 and Placebo in Otomycosis, sponsored by Salvat. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-15.
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
Also known as: SVT-15652 Otic Solution
1 vial twice daily
Therapeutic Cure (Clinical and Mycological Cure)
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 | 75 | 35 |
| Completed | 70 | 27 |
| Not completed | 5 | 8 |
| Withdrew: Lack of efficacy | 3 | 5 |
| Withdrew: Adverse event | 0 | 1 |
| Withdrew: Protocol violation | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Covid pandemic, bacterial ear culture | 2 | 0 |
Percentage of subjects with therapeutic cure
| Participants | SVT-15652 | Placebo |
|---|---|---|
| Therapeutic Cure (Clinical and Mycological Cure) | 59 | 8 |
Collected over Overall study period (about 4 weeks). Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| SVT-15652 | 0/127 (0%) | 0/127 (0%) | 0/127 (0%) |
| Placebo | 0/64 (0%) | 1/64 (1.6%) | 3/64 (4.7%) |
| Event | SVT-15652 | Placebo |
|---|---|---|
| LabyrinthitisInfections and infestations | 0/127 | 1/64 |
| CholesteatomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/127 | 1/64 |
| Event | SVT-15652 | Placebo |
|---|---|---|
| DizzinessNervous system disorders | 0/127 | 3/64 |
MITT Population: Randomized patients who had positive baseline fungal culture for Aspergillus spp and/or Candida spp
| Age, Continuous(years) | SVT-15652 | Placebo | Total |
|---|---|---|---|
| Mean | 52.8 ± 15.50 | 51.5 ± 15.78 | 52.4 ± 15.53 |
| Sex: Female, Male(Participants) | SVT-15652 | Placebo | Total |
|---|---|---|---|
| Female | 35 | 15 | 50 |
| Male | 40 | 20 | 60 |
| Race (NIH/OMB)(Participants) | SVT-15652 | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 0 | 1 |
| White | 72 | 34 | 106 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | SVT-15652 | Placebo | Total |
|---|---|---|---|
| Europe | 75 | 35 | 110 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Jun 2020 to primary completion in Oct 2021, 16 months.
Results were first posted in Dec 2022, 1 year 1 month after primary completion.
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Studies of the drug tested here: Clotrimazole
Otomycosis
Salvat