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Last Updated: March 3, 2021

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CLINICAL TRIALS PROFILE FOR OTO-104

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Clinical Trials for OTO-104

Trial ID Title Status Sponsor Phase Summary
NCT01084525 OTO-104 for Meniere's Disease Completed Otonomy, Inc. Phase 1 The purpose of this study is to evaluate the safety of OTO-104 in subjects with unilateral Meniere's disease. The effectiveness of OTO-104 to reduce the symptoms of Meniere's disease will also be evaluated.
NCT01138137 N-acetylcysteine Given IV With Cisplatin and Paclitaxel in Patients With Ovarian Cancer Withdrawn OHSU Knight Cancer Institute Phase 1 RATIONAL FOR STUDYING IV NAC AS POTENTIAL CHEMOPROTECTANT: Cisplatin has shown efficacy in the treatment of subjects with epithelial ovarian cancer. Systemic toxicities associated with cisplatin include nephro, oto, and nerve toxicities. It may be possible to reduce the toxicities of cisplatin by administering it in conjunction with IV NAC. NAC may reduce cisplatin related nephro, oto, and nerve toxicities without compromising the effectiveness of the chemotherapy against the ovarian cancer cells. It is possible that this combination of drugs may in the future allow ovarian cancer patients to receive the full series of IP cisplatin-paclitaxel chemotherapy, with fewer side effects and improved survival. It is hypothesized that the proposed treatment of stage III or IV epithelial ovarian cancer with IP cisplatin and IV/IP paclitaxel in conjunction with IV NAC will limit the neurotoxicity, nephrotoxicity and ototoxicity that is associated with cisplatin administration.
NCT01412177 OTO-104 for the Treatment of Meniere's Disease Completed Otonomy, Inc. Phase 2 The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
NCT01755286 OTO-201 for Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement Completed Otonomy, Inc. Phase 1 The purpose of this study is to describe the safety and tolerability of two dose levels of OTO-201, placebo and sham when administered intra-operatively in pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
NCT01949142 OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement Completed Otonomy, Inc. Phase 3 The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
NCT01949155 OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement Completed Otonomy, Inc. Phase 3 The purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
NCT02265393 A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom Completed Otonomy, Inc. Phase 2 This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United Kingdom. The first part is a randomized, placebo-controlled study comparing the safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1 year.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for OTO-104

Condition Name

Condition Name for
Intervention Trials
Meniere's Disease 8
Acute Otitis Media 2
AOMT 2
Otitis Media With Effusion 2
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Condition MeSH

Condition MeSH for
Intervention Trials
Meniere Disease 9
Otitis 7
Otitis Media 5
Otitis Media with Effusion 4
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Clinical Trial Locations for OTO-104

Trials by Country

Trials by Country for
Location Trials
United States 46
Canada 2
Egypt 1
United Kingdom 1
Norway 1
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Trials by US State

Trials by US State for
Location Trials
California 17
North Carolina 4
South Carolina 4
Florida 3
Michigan 2
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Clinical Trial Progress for OTO-104

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 1
Phase 3 10
Phase 2 7
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Completed 13
Recruiting 6
Enrolling by invitation 2
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Clinical Trial Sponsors for OTO-104

Sponsor Name

Sponsor Name for
Sponsor Trials
Otonomy, Inc. 21
Sorlandet Hospital HF 1
Assiut University 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 21
Other 3
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