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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

July 31, 2011
September 10, 2012
Not Provided
Not Provided
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 ]
Same as current
Complete list of historical versions of study NCT01412177 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
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OTO-104 for the Treatment of Meniere's Disease
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

The purpose of this study is to evaluate the effectiveness of OTO-104 for the treatment of Meniere's disease.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Meniere's Disease
  • Drug: OTO-104
    Single intratympanic injection of 12 mg OTO-104.
  • Drug: Placebo
    Single intratympanic injection of placebo
  • Experimental: OTO-104 (steroid) 12 mg
    Intervention: Drug: OTO-104
  • Placebo Comparator: Vehicle for OTO-104
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
140
Not Provided
Not Provided

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.
Both
18 Years to 80 Years
No
Contact: Carl LeBel, PhD (858) 242-5213 CLeBel@Otonomy.com
Not Provided
 
NCT01412177
104-201102
Yes
Otonomy, Inc.
Otonomy, Inc.
Not Provided
Study Chair: Carl LeBel, PhD Otonomy, Inc.
Otonomy, Inc.
September 2012

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