17 completed, 5 terminated. 10 Phase 2, 10 Phase 3, 4 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 10 | Completed 8, Terminated 2 |
| Phase 3 | 10 | Completed 7, Terminated 3 |
| Phase 1 | 4 | Completed 4 |
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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 |
|---|---|---|---|---|---|---|
| OTO-313 in Subjects With Unilateral Subjective Tinnitus OTO-313, Placebo - Subjective Tinnitus | Phase 2 | Completed | Otonomy, Inc. | 153 | 2021-03-22 | 2023-01-06 |
| OTO-413 in Subjects With Speech-in-Noise Hearing Impairment OTO-413, Placebo - Sensorineural Hearing Loss | Phase 1 / Phase 2 | Completed | Otonomy, Inc. | 110 | 2019-10-01 | 2022-10-27 |
| OTO-313 in Subjects With Subjective Tinnitus OTO-313, Placebo - Tinnitus, Subjective | Phase 1 / Phase 2 | Completed | Otonomy, Inc. | 43 | 2019-04-04 | 2022-12-23 |
| 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 |
| Study of OTO-104 in Subjects at Risk From Cisplatin-Induced Hearing Loss OTO-104 - Cisplatin Induced Hearing Loss | Phase 2 | Terminated | Otonomy, Inc. | 12 | 2016-11-15 | 2020-09-16 |
| 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 |
| Open Label Study of OTO-104 in Subjects With Meniere's Disease OTO-104 - Meniere's Disease | Phase 2 | Terminated | Otonomy, Inc. | 34 | 2016-06-01 | 2017-09-15 |
| 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 |
| Dose Ranging Study of OTO-201 in AOMT 6 mg ciprofloxacin, 12 mg ciprofloxacin, Sham - Acute Otitis Media, AOMT | Phase 2 | Completed | Otonomy, Inc. | 95 | 2016-02-01 | 2020-10-19 |
| 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 |
| OTO-201 for the Treatment of Otitis Externa OTO-201 (ciprofloxacin) - Otitis Externa | Phase 2 | Completed | Otonomy, Inc. | 75 | 2015-07-01 | 2020-10-19 |
| Open-Label Study of OTO-201 for Treatment of AOMT OTO-201 - Acute Otitis Media, AOMT | Phase 2 | Completed | Otonomy, Inc. | 39 | 2015-03-01 | 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 |
| A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom OTO-104, Placebo - Meniere's Disease | Phase 2 | Completed | Otonomy, Inc. | 128 | 2014-10-01 | 2017-08-18 |
| 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-104 for the Treatment of Meniere's Disease OTO-104, Placebo - Meniere's Disease | Phase 2 | Completed | Otonomy, Inc. | 154 | 2013-11-01 | 2015-09-03 |
| 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 |
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Meniere Disease (9) · Otitis Media (5) · Vertigo (5) · Tinnitus (4) · Hearing Loss (3) · Otitis (2) · Otitis Externa (2) · Otitis Media with Effusion (2) · Ear Diseases (1) · Endolymphatic Hydrops (1) · Hearing Loss, Hidden (1) · Hearing Loss, Sensorineural (1) · Labyrinth Diseases (1) · Otorhinolaryngologic Diseases (1)
Ciprofloxacin (5) · salicylhydroxamic acid (4) · Injection, Intratympanic (1) · Steroids (1)
United States (20) · United Kingdom (3) · Canada (2) · Germany (2) · Poland (2) · Belgium (1) · Italy (1) · Spain (1) · Turkey (Türkiye) (1)
Carl LeBel, PhD (11) · Kathie Bishop, PhD (6) · Dean Hakanson, MD (1)