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Trial record 4 of 4 for:    unilateral meniere's disease
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OTO-104 for the Treatment of Meniere's Disease

This study is not yet open for participant recruitment.
Verified September 2012 by Otonomy, Inc.
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.
ClinicalTrials.gov Identifier:
NCT01412177
First received: July 31, 2011
Last updated: September 10, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention Phase
Meniere's Disease
 Drug: OTO-104
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Double-blind, Placebo-controlled, Multicenter, Phase 2 Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Otonomy, Inc.:

Primary Outcome Measures:
  • Reduction in vertigo frequency as measure of efficacy of OTO-104 in subjects with Meniere's disease [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of adverse events, otoscopic exams, audiometry, Word Recognition Score and tympanometry as a measure of safety and tolerability [ Time Frame: 4 months ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • Evaluation of patient reported questionnaires as a measure of impact on patient daily activities [ Time Frame: 4 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Arms Assigned Interventions
Experimental: OTO-104 (steroid) 12 mg Drug: OTO-104
Single intratympanic injection of 12 mg OTO-104.
Placebo Comparator: Vehicle for OTO-104 Drug: Placebo
Single intratympanic injection of placebo

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01412177

Contacts
Contact: Carl LeBel, PhD (858) 242-5213 CLeBel@Otonomy.com

Sponsors and Collaborators
Otonomy, Inc.
Investigators
Study Chair: Carl LeBel, PhD Otonomy, Inc.
  More Information

No publications provided

Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT01412177     History of Changes
Other Study ID Numbers: 104-201102
Study First Received: July 31, 2011
Last Updated: September 10, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

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

ClinicalTrials.gov processed this record on May 23, 2013