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出境医 / 临床实验 / OTO-313 in Subjects With Subjective Tinnitus

OTO-313 in Subjects With Subjective Tinnitus

Study Description
Brief Summary:
The purpose of this study is to evaluate the safety, tolerability, plasma pharmacokinetics (PK), and exploratory efficacy of OTO-313 administered as an intratympanic injection for the treatment of subjective tinnitus.

Condition or disease Intervention/treatment Phase
Tinnitus, Subjective Drug: OTO-313 Drug: Placebo Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized, double-blind, placebo-controlled, multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Subjective Tinnitus
Actual Study Start Date : April 4, 2019
Actual Primary Completion Date : May 29, 2020
Actual Study Completion Date : May 29, 2020
Arms and Interventions
Arm Intervention/treatment
Experimental: OTO-313 Drug: OTO-313
single intratympanic injection of gacyclidine
Placebo Comparator: Placebo Drug: Placebo
single intratympanic injection of placebo
Outcome Measures
Primary Outcome Measures :
  1. Treatment Emergent Adverse Events [ Time Frame: Reported or observed during or after dosing (Day 1) up to end of study (Day 57 - 8 weeks after dosing) ]
    An adverse event (AE) is any unfavorable and unintended diagnosis, symptom, sign, syndrome or disease which occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen.

  2. Audiometry [ Time Frame: After dosing (Day 1) up to end of study (Day 57 - 8 weeks after dosing) ]
    Clinically significant adverse change from Baseline

  3. Otoscopic Examinations [ Time Frame: After dosing (Day 1) up to end of study (Day 57 - 8 weeks after dosing) ]
    Clinically significant adverse change from Baseline


Secondary Outcome Measures :
  1. Plasma Pharmacokinetics (PK) [ Time Frame: Specified timepoints for the first 24 hours and 1 week later ]
    Concentrations of gacyclidine in plasma


Other Outcome Measures:
  1. Tinnitus Functional Index [ Time Frame: At screening, baseline (Day 1), Day 15, Day 29, Day 57 ]
    Validated, 25-item questionnaire; index score from 0 to 100; higher scores indicate greater problem with tinnitus

  2. Daily Tinnitus Annoyance [ Time Frame: Start of Lead-in (Day -14) to end of study (Day 57) ]
    Numerical rating scale from 0 (Not Annoying) to 10 (Extremely Annoying) collected every day

  3. Daily Tinnitus Loudness [ Time Frame: Start of Lead-in (Day -14) to end of study (Day 57) ]
    Numerical rating scale from 0 (No Tinnitus) to 10 (Extremely Loud Tinnitus) collected every

  4. Patient Global Impression of Change [ Time Frame: Day 8, Day 15, Day 29, Day 57 ]
    Change in overall tinnitus status as perceived by the subject


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject has subjective unilateral tinnitus and is consistently aware of their tinnitus throughout much of the waking day.
  • Subject is able to use the electronic 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, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
  • Subject is pregnant or lactating.
  • Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline (Day 1) that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.
Contacts and Locations

Locations
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United States, California
House Clinic
Los Angeles, California, United States, 90057
California Head & Neck Specialists
San Diego, California, United States, 92121
United States, Colorado
Colorado ENT and Allergy
Colorado Springs, Colorado, United States, 80909
United States, Florida
Silverstein Institute/Ear Research Foundation
Sarasota, Florida, United States, 34239
United States, Illinois
ChicagoENT
Chicago, Illinois, United States, 60657
United States, Kentucky
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40207
United States, Louisiana
Tandem Clinical Research, LLC
Marrero, Louisiana, United States, 70072
United States, New Jersey
Summit Medical Group
Berkeley Heights, New Jersey, United States, 10882
United States, New York
Dent Neurosciences Research Center
Amherst, New York, United States, 14226
Northwell Health, Hearing & Speech Center
New Hyde Park, New York, United States, 11042
Northwell Health at ENT and Allergy Associates
White Plains, New York, United States, 10605
United States, North Carolina
Charlotte Eye Ear Nose & Throat Associates
Charlotte, North Carolina, United States, 28210
Piedmont Ear, Nose, and Throat Associates
Winston-Salem, North Carolina, United States, 27103
United States, Texas
Worldwide Clinical Trials
San Antonio, Texas, United States, 78217
United States, Utah
Chrysalis Clinical Research
Saint George, Utah, United States, 84790
United States, West Virginia
WVU Medicine
Morgantown, West Virginia, United States, 26506
Sponsors and Collaborators
Otonomy, Inc.
Tracking Information
First Submitted Date  ICMJE April 15, 2019
First Posted Date  ICMJE April 17, 2019
Last Update Posted Date June 17, 2020
Actual Study Start Date  ICMJE April 4, 2019
Actual Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2019)
  • Treatment Emergent Adverse Events [ Time Frame: Reported or observed during or after dosing (Day 1) up to end of study (Day 57 - 8 weeks after dosing) ]
    An adverse event (AE) is any unfavorable and unintended diagnosis, symptom, sign, syndrome or disease which occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen.
  • Audiometry [ Time Frame: After dosing (Day 1) up to end of study (Day 57 - 8 weeks after dosing) ]
    Clinically significant adverse change from Baseline
  • Otoscopic Examinations [ Time Frame: After dosing (Day 1) up to end of study (Day 57 - 8 weeks after dosing) ]
    Clinically significant adverse change from Baseline
Original Primary Outcome Measures  ICMJE
 (submitted: April 15, 2019)
  • Treatment Emergent Adverse Events [ Time Frame: Reported or observed during or after dosing (Day 1) up to end of study (Day 57 - 8 weeks after dosing) ]
    An AE is any unfavorable and unintended diagnosis, symptom, sign, syndrome or disease which occurs during the study, having been absent at baseline, or, if present at baseline, appears to worsen.
  • Audiometry [ Time Frame: After dosing (Day 1) up to end of study (Day 57 - 8 weeks after dosing) ]
    Clinically significant adverse change from Baseline
  • Otoscopic Examinations [ Time Frame: After dosing (Day 1) up to end of study (Day 57 - 8 weeks after dosing) ]
    Clinically significant adverse change from Baseline
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2019) 		Plasma Pharmacokinetics (PK) [ Time Frame: Specified timepoints for the first 24 hours and 1 week later ]
Concentrations of gacyclidine in plasma
Original Secondary Outcome Measures  ICMJE
 (submitted: April 15, 2019) 		Plasma PK [ Time Frame: Specified timepoints for the first 24 hours and 1 week later ]
Concentrations of gacyclidine in plasma
Current Other Pre-specified Outcome Measures
 (submitted: June 5, 2019)
  • Tinnitus Functional Index [ Time Frame: At screening, baseline (Day 1), Day 15, Day 29, Day 57 ]
    Validated, 25-item questionnaire; index score from 0 to 100; higher scores indicate greater problem with tinnitus
  • Daily Tinnitus Annoyance [ Time Frame: Start of Lead-in (Day -14) to end of study (Day 57) ]
    Numerical rating scale from 0 (Not Annoying) to 10 (Extremely Annoying) collected every day
  • Daily Tinnitus Loudness [ Time Frame: Start of Lead-in (Day -14) to end of study (Day 57) ]
    Numerical rating scale from 0 (No Tinnitus) to 10 (Extremely Loud Tinnitus) collected every
  • Patient Global Impression of Change [ Time Frame: Day 8, Day 15, Day 29, Day 57 ]
    Change in overall tinnitus status as perceived by the subject
Original Other Pre-specified Outcome Measures
 (submitted: April 15, 2019)
  • Tinnitus Functional Index [ Time Frame: At screening, baseline (Day 1), Day 8, Day 15, Day 29, Day 57 ]
    Validated, 25-item questionnaire; index score from 0 to 100; higher scores indicate greater problem with tinnitus
  • Daily Tinnitus Annoyance [ Time Frame: Start of Lead-in (Day -14) to end of study (Day 57) ]
    Numerical rating scale from 0 (Not Annoying) to 10 (Extremely Annoying) collected every day
  • Daily Tinnitus Loudness [ Time Frame: Start of Lead-in (Day -14) to end of study (Day 57) ]
    Numerical rating scale from 0 (No Tinnitus) to 10 (Extremely Loud Tinnitus) collected every
  • Patient Global Impression of Change [ Time Frame: Day 8, Day 15, Day 29, Day 57 ]
    Change in overall tinnitus status as perceived by the subject
 
Descriptive Information
Brief Title  ICMJE OTO-313 in Subjects With Subjective Tinnitus
Official Title  ICMJE A Randomized, Double-blind, Placebo-controlled Phase 1/2 Study of OTO-313 Given as a Single Intratympanic Injection in Subjects With Subjective Tinnitus
Brief Summary The purpose of this study is to evaluate the safety, tolerability, plasma pharmacokinetics (PK), and exploratory efficacy of OTO-313 administered as an intratympanic injection for the treatment of subjective tinnitus.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, double-blind, placebo-controlled, multicenter
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Tinnitus, Subjective
Intervention  ICMJE
  • Drug: OTO-313
    single intratympanic injection of gacyclidine
  • Drug: Placebo
    single intratympanic injection of placebo
Study Arms  ICMJE
  • Experimental: OTO-313
    Intervention: Drug: OTO-313
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 15, 2020) 		43
Original Estimated Enrollment  ICMJE
 (submitted: April 15, 2019) 		58
Actual Study Completion Date  ICMJE May 29, 2020
Actual Primary Completion Date May 29, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has subjective unilateral tinnitus and is consistently aware of their tinnitus throughout much of the waking day.
  • Subject is able to use the electronic 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, tinnitus resulting from traumatic head or neck injury, or tinnitus resulting from a tumor or stroke.
  • Subject is pregnant or lactating.
  • Subject has other clinically significant illness, medical condition or medical history at Screening or Baseline (Day 1) that, in the Investigator's opinion, would likely reduce the safety of study participation or compliance with study procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03918109
Other Study ID Numbers  ICMJE 313-201901
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Otonomy, Inc.
Study Sponsor  ICMJE Otonomy, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Otonomy, Inc.
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP