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OTO-104 for the Treatment of Meniere's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01412177
Recruitment Status : Completed
First Posted : August 9, 2011
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.

Condition or disease Intervention/treatment Phase
Meniere's Disease Drug: OTO-104 Drug: Placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2b Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease
Study Start Date : November 2013
Primary Completion Date : March 2015
Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: OTO-104 Drug: OTO-104
Single intratympanic injection of 12 mg OTO-104
Placebo Comparator: Placebo Drug: Placebo
Single intratympanic injection of placebo


Outcome Measures

Primary Outcome Measures :
  1. Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease [ Time Frame: 4 months ]

Secondary Outcome Measures :
  1. Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability [ Time Frame: 4 months ]
  2. Evaluation of tinnitus patient reported questionnaire and daily diary as a measure of impact of tinnitus on activities of daily living [ Time Frame: 4 months ]
  3. Evaluation of patient reported questionnaires as a measure of impact on patient daily activities [ Time Frame: 4 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.
  • Subjects currently on a low-salt diet and/or diuretic at the time of screening agree to continue this treatment throughout the study.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412177


Locations
United States, California
Many sites in US and Canada. Refer to the contact info listed below.
San Diego, California, United States
United States, Ohio
UC Health Otolaryngology - Head and Neck Surgery
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
Otonomy, Inc.
Investigators
Study Chair: Carl LeBel, PhD Otonomy, Inc.
More Information

Additional Information:
Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT01412177     History of Changes
Other Study ID Numbers: 104-201102
First Posted: August 9, 2011    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: August 2015

Keywords provided by Otonomy, Inc.:
Meniere's Disease
Vertigo
Definitive vertigo
Vertigo episodes
Vertigo frequency
Tinnitus
Hearing loss
Aural fullness

Additional relevant MeSH terms:
Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases