OTO-313 in Subjects With Unilateral Subjective Tinnitus
A Randomized, Double-blind, Placebo-controlled Phase 2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Unilateral Subjective Tinnitus
Sponsors |
Lead Sponsor: Otonomy, Inc. |
---|---|
Source | Otonomy, Inc. |
Brief Summary | The purpose of this study is to determine the efficacy of OTO-313 in subjects with unilateral tinnitus and to determine the safety and tolerability of OTO-313 in subjects with unilateral tinnitus. |
Overall Status | Completed | ||||||||
---|---|---|---|---|---|---|---|---|---|
Start Date | 2021-03-22 | ||||||||
Completion Date | 2022-06-30 | ||||||||
Primary Completion Date | 2022-06-30 | ||||||||
Phase | Phase 2 | ||||||||
Study Type | Interventional | ||||||||
Primary Outcome |
|
||||||||
Secondary Outcome |
|
||||||||
Enrollment | 153 |
Condition | |
---|---|
Intervention |
Intervention Type: Drug Intervention Name: OTO-313 Description: Single intratympanic injection Arm Group Label: OTO-313 Intervention Type: Drug Intervention Name: Placebo Description: Single intratympanic injection Arm Group Label: Placebo |
Eligibility |
Criteria:
Inclusion Criteria: - Subject has early-onset subjective unilateral tinnitus that is persistent (consistently aware of their tinnitus throughout much of the waking day). - Subject is able to use the diary to complete their daily tinnitus ratings. - Subject's tinnitus is likely of cochlear origin, e.g., associated with sensorineural hearing loss; acute hearing loss from noise trauma, barotrauma, or traumatic cochlear injury (acute acoustic trauma, blast trauma, middle ear surgery, inner ear barotrauma); age related hearing loss; resolved otitis media; ototoxic drug exposure. - Subject is willing to comply with the protocol and attend all study visits. Exclusion Criteria: - Subject has pulsatile tinnitus, temporomandibular joint disease (TMJ) associated with tinnitus perception, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke. - Subject is pregnant, lactating, or undergoing fertility treatment. - Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures. Gender: All Minimum Age: 18 Years Maximum Age: 75 Years Healthy Volunteers: No |
Overall Contact | Contact information is only displayed when the study is recruiting subjects. | |||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Location |
|
Location Countries |
Germany Poland United Kingdom United States |
---|---|
Verification Date |
2022-06-01 |
Responsible Party |
Type: Sponsor |
Keywords | |
Has Expanded Access | No |
Condition Browse | |
Number Of Arms | 2 |
Arm Group |
Label: OTO-313 Type: Experimental Label: Placebo Type: Placebo Comparator |
Patient Data | No |
Study Design Info |
Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Randomized, double-blind, placebo-controlled, multicenter Primary Purpose: Treatment Masking: Triple (Participant, Investigator, Outcomes Assessor) |
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Subjective Tinnitus
-
NCT04987502Not yet recruitingConditions: Tinnitus, Tinnitus, Subjective
-
NCT04551404RecruitingConditions: Tinnitus, Tinnitus, Subjective
-
NCT04404439RecruitingConditions: Tinnitus, Subjective, Tinnitus
-
NCT03425045CompletedConditions: Tinnitus, Subjective
-
NCT03209297CompletedConditions: Tinnitus, Subjective
-
NCT03688113CompletedConditions: Tinnitus, Subjective
-
NCT04449237Not yet recruitingConditions: Tinnitus, Subjective
-
NCT03131674WithdrawnConditions: Tinnitus, Subjective
-
NCT03782220CompletedConditions: Tinnitus, Subjective
-
NCT01177137CompletedConditions: Subjective Tinnitus
Clinical Trials on OTO-313
-
NCT03918109CompletedConditions: Tinnitus, Subjective
-
NCT04829214CompletedConditions: Subjective Tinnitus