A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

ClinicalTrials.gov processed this data on December 19, 2022. Link to the current ClinicalTrials.gov record.

Recruitment Status

TERMINATED - HAS RESULTS
 (See Contacts and Locations)
Verified December 2022 by Otonomy, Inc.

Sponsor

Otonomy, Inc.

Information Provided by (Responsible Party)

Otonomy, Inc.

Clinicaltrials.gov Identifier

NCT02717442
Other Study ID Numbers: 104-201508
First Submitted: March 10, 2016
First Posted: March 23, 2016
Results First Posted: January 13, 2023
Last Update Posted: January 13, 2023
Last Verified: December 2022
History of Changes

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Study Description

Not Provided
Condition or Disease Intervention/Treatment
  • Meniere's Disease
  • Drug: OTO-104
  • Drug: Placebo

Study Design

Study TypeInterventional
Actual Enrollment176 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 3 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Study Start DateMarch 21, 2016
Actual Primary Completion DateAugust 31, 2017
Actual Study Completion DateSeptember 15, 2017

Groups and Cohorts

Group/ CohortIntervention/ Treatment
  • OTO-104
    • 12 mg dexamethasone
  • Drug: OTO-104
    • Single intratympanic injection of 12 mg OTO-104
  • Placebo
  • Drug: Placebo

    Outcome Measures

    Primary Outcome Measures

    1. The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-1 Population [3 months]
      In the Full Analysis Set (FAS)-1 population, the number of DVDs at Week 12 (the 4-week [28 days] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.
    2. The Number of DVD at Week 12 (the 4-week [28 Days] Interval From Week 9 Through Week 12) - FAS-2 Population [3 months]
      The number of DVDs at Week 12 (the 4-week [28 days] interval from Week 9 through Week 12) was compared between OTO-104 and placebo. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.

    Secondary Outcome Measures

    1. Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-1 [3 months]
      Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.

      Questionnaire - subjects were instructed to record the effect on their daily activities of their total vertigo experienced that day using a 5-point scoring system:

      0 = normal activity

      = slight limitation

      = moderate limitation

      = sick at home

      = bedridden
    2. Effect of Vertigo on Daily Activities - Number of Days Sick at Home or Bedridden at Week 12 (Month 3): FAS-2 [3 months]
      Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.

      Questionnaire - subjects were instructed to record the effect on their daily activities of their total vertigo experienced that day using a 5-point scoring system:

      0 = normal activity

      = slight limitation

      = moderate limitation

      = sick at home

      = bedridden
    3. Otoscopic Examination - Tympanic Membrane Perforation at Week 12 (Month 3) [3 months]
      Otoscopic examinations were conducted at each visit. It was considered important to understand if the tympanic perforation that resulted from the IT injection at the Baseline visit persisted at the end of study visit (Week12 [Month 3]). Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.
    4. Audiometry - Shift in Air-Bone Gap at 500 Hz From Baseline to Week 12 (Month 3) [3 Months]
      The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment (<=10 dB) to impairment (>10 dB) when measure at 500 Hz. Week 12 = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.
    5. Audiometry - Shift in Air-Bone Gap at 1000 Hz From Baseline to Week 12 (Month 3) [3 months]
      The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 1000 Hz. Week 12 (Month 3) = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.
    6. Audiometry - Shift in Air-Bone Gap at 2000 Hz From Baseline to Week 12 (Month 3) [3 months]
      The number of subjects with a change in air-bone gap from Baseline to Week 12 (Month 3) from no impairment at baseline (<= 10 dB) to impairment at Month 3 (>10 dB) when measured at 2000 Hz. Week 12 (Month 3) = 12 weeks after dosing at the Baseline visit. The Baseline visit occurred at the end of lead-in. No intervention was administered during lead-in.

    Eligibility Criteria

    Ages Eligible for Study 18 Years to 85 Years (Adult, Older Adult)
    Sexes Eligible for Study All
    Accepts Healthy Volunteers No
    Inclusion Criteria
    • cludes, but is not limited to:
    • Subject has a diagnosis of unilateral Meniere's disease by 1995 American Academy of Otolaryngology - Head and Neck Surgery (AAOHNS) criteria and reports active vertigo for the 2 months prior to the study lead-in period.
    • Subject has experienced active vertigo during the lead-in period.
    • Subject has documented asymmetric sensorineural hearing loss.
    • Subject agrees to maintain their current treatments for Meniere's disease while on-study.
    Exclusion Criteria
    • cludes, but is not limited to:
    • Subject is pregnant or lactating.
    • Subject has a history of immunodeficiency disease.
    • Subject has a history of previous endolymphatic sac surgery.
    • Subject has a history of previous use of intratympanic (IT) gentamicin in the affected ear.
    • Subject has a history of tympanostomy tubes with evidence of perforation or lack of closure.
    • Subject has experienced an adverse reaction to IT injection of steroids.
    • Subject has used an investigational drug or device in the 3 months prior to screening.
    • Subject has previously been randomized to a trial of OTO-104.

    Contacts and Locations

    Sponsors and Collaborators Otonomy, Inc.
    Locations
    • Many sites in Europe. Refer to the contact info listed below. | San Diego, California, United States, 92121
    Investigators

      Study Documents (Full Text)

      More Information

      Additional Relevant MeSH Terms

      • Meniere Disease
      • Endolymphatic Hydrops
      • Labyrinth Diseases
      • Ear Diseases
      • Otorhinolaryngologic Diseases