A Phase 3 interventional study of 12 mg ciprofloxacin and Sham Control in Acute Otitis Externa and Swimmer's Ear, sponsored by Otonomy, Inc.. Completed at 2 sites in 2 countries. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2020-10-19.
Sponsored by Otonomy, Inc. · Phase 3, Interventional, and Treatment
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).
22 studies on the registry are indexed under Otitis Externa; 1 is open to participants now.
This study's enrollment of 262 is above the median of 100 across 20 interventional studies indexed under Otitis Externa.
Browse Otitis Externa studies →Otonomy, Inc. is the lead sponsor of 22 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria includes, but is not limited to:
Exclusion Criteria includes, but is not limited to:
Drug: 12 mg ciprofloxacin
Drug: Sham Control
Single administration of OTO-201
Also known as: OTIPRIO
Simulated, single adminstration
Number of Subjects Considered a Clinical Cure at Day 8
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3
Time frame: At Day 8 (1 week after dosing)
Number of Subjects Considered a Clinical Cure at Day 15
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3
Time frame: At Day 15 (2 weeks after dosing)
| Milestone | 12 mg OTO-201 | Control |
|---|---|---|
| Started | 130 | 132 |
| Completed | 123 | 132 |
| Not completed | 7 | 0 |
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3
| Participants | 12 mg OTO-201 | Control |
|---|---|---|
| Number of Subjects Considered a Clinical Cure at Day 8 | 91 | 63 |
Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows: None = 0 Mild = 1 Moderate = 2 Severe = 3
| Participants | 12 mg OTO-201 | Control |
|---|---|---|
| Number of Subjects Considered a Clinical Cure at Day 15 | 97 | 69 |
Collected over Adverse events were reported during dosing and up to 1 month following dosing.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| 12 mg OTO-201 | 0/127 (0%) | 0/127 (0%) | 12/127 (9.4%) |
| Control | 0/132 (0%) | 0/132 (0%) | 18/132 (13.6%) |
| Event | 12 mg OTO-201 | Control |
|---|---|---|
| Otitis externaInfections and infestations | 3/127 | 9/132 |
| Ear PainEar and labyrinth disorders | 3/127 | 3/132 |
| Ear pruritisEar and labyrinth disorders | 3/127 | 2/132 |
| HeadacheNervous system disorders | 3/127 | 1/132 |
| ErythemaSkin and subcutaneous tissue disorders | 0/127 | 3/132 |
262 subjects randomized (132 sham, 130 OTO-201). 2 sham subjects positive for Group A strep and not in ITT population (Baseline characteristics and efficacy) leaving 130 sham, 130 OTO-201. ITT subjects analyzed as randomized. Safety population (AE/SAE) analyzed by what was received (132 sham, 127 OTO-201) regardless of culture, but had be dosed.
| Age, Continuous(years) | 12 mg OTO-201 | Control | Total |
|---|---|---|---|
| Mean | 36.724 ± 20.5866 | 34.796 ± 19.2708 | 35.760 ± 19.9244 |
| Sex: Female, Male(Participants) | 12 mg OTO-201 | Control | Total |
|---|---|---|---|
| Female | 75 | 75 | 150 |
| Male | 55 | 55 | 110 |
| Ethnicity (NIH/OMB)(Participants) | 12 mg OTO-201 | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 41 | 43 | 84 |
| Not Hispanic or Latino | 87 | 86 | 173 |
| Unknown or Not Reported | 2 | 1 | 3 |
| Race (NIH/OMB)(Participants) | 12 mg OTO-201 | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 3 | 3 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 14 | 15 | 29 |
| White | 111 | 109 | 220 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 4 | 3 | 7 |
| Region of Enrollment(participants) | 12 mg OTO-201 | Control | Total |
|---|---|---|---|
| United States | 130 | 130 | 260 |
Plan to share: No
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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ciprofloxacin