7 completed, 3 terminated. 10 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 10 | Completed 7, Terminated 3 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Phase 3 Study of OTO-104 in Subjects With Unilateral Meniere's Disease OTO-104, Placebo - Meniere Disease | Phase 3 | Completed | Otonomy, Inc. | 148 | 2018-08-27 | 2022-12-07 |
| A 6-Month Extension Study of OTO-104 in Meniere's Disease OTO-104 - Meniere's Disease | Phase 3 | Terminated | Otonomy, Inc. | 142 | 2016-08-01 | 2023-01-20 |
| Phase 3 Study of OTO-201 in Acute Otitis Externa 12 mg ciprofloxacin, Sham Control - Acute Otitis Externa, Swimmer's Ear | Phase 3 | Completed | Otonomy, Inc. | 262 | 2016-06-01 | 2020-10-19 |
| Study of OTO-104 in Subjects With Unilateral Meniere's Disease OTO-104, Placebo - Meniere's Disease | Phase 3 | Terminated | Otonomy, Inc. | 176 | 2016-03-21 | 2023-01-13 |
| A 6-Month Extension Study of OTO-104 in Meniere's Disease OTO-104 - Meniere's Disease | Phase 3 | Terminated | Otonomy, Inc. | 189 | 2016-02-01 | 2022-12-14 |
| Study of OTO-104 in Subjects With Unilateral Meniere's Disease OTO-104, Placebo - Meniere's Disease | Phase 3 | Completed | Otonomy, Inc. | 166 | 2015-10-27 | 2023-01-12 |
| Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes OTO-201 (ciprofloxacin) - Otitis Media | Phase 3 | Completed | Otonomy, Inc. | 501 | 2015-10-01 | 2020-10-19 |
| Open-Label Study of OTO-201 for Middle Ear Effusion Evaluating Trans-Tympanostomy Tube Administration OTO-201 - Bilateral Middle Ear Effusion | Phase 3 | Completed | Otonomy, Inc. | 33 | 2015-01-01 | 2020-10-19 |
| OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement OTO-201, Sham - Otitis Media With Effusion | Phase 3 | Completed | Otonomy, Inc. | 266 | 2013-11-01 | 2016-06-15 |
| OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement OTO-201, Sham - Otitis Media With Effusion | Phase 3 | Completed | Otonomy, Inc. | 266 | 2013-11-01 | 2016-11-11 |
Meniere Disease (5) · Otitis Media (3) · Vertigo (3) · Otitis Media with Effusion (2) · Ear Diseases (1) · Endolymphatic Hydrops (1) · Labyrinth Diseases (1) · Otitis (1) · Otitis Externa (1) · Otorhinolaryngologic Diseases (1)
Ciprofloxacin (2) · salicylhydroxamic acid (2)
United States (10) · Belgium (1) · Canada (1) · Germany (1) · Italy (1) · Poland (1) · Spain (1) · Turkey (Türkiye) (1) · United Kingdom (1)
Carl LeBel, PhD (4) · Kathie Bishop, PhD (4) · Dean Hakanson, MD (1)