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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| NCT01138137 | N-acetylcysteine Given IV With Cisplatin and Paclitaxel in Patients With Ovarian Cancer | Withdrawn | OHSU Knight Cancer Institute | Phase 1 | RATIONAL FOR STUDYING IV NAC AS POTENTIAL CHEMOPROTECTANT: Cisplatin has shown efficacy in the treatment of subjects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 | >Sponsor | >Phase | >Summary |
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