OTO-104 for the Treatment of Meniere's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Otonomy, Inc.
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.
ClinicalTrials.gov Identifier:
NCT01412177
First received: July 31, 2011
Last updated: July 10, 2014
Last verified: July 2014

July 31, 2011
July 10, 2014
November 2013
April 2015   (final data collection date for primary outcome measure)
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
Not Provided
Not Provided
 
OTO-104 for the Treatment of Meniere's Disease
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

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
    Intervention: Drug: OTO-104
  • Placebo Comparator: Placebo
    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.
 
Recruiting
140
May 2015
April 2015   (final data collection date for primary outcome measure)

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: Liza Wallace, RN (858) 242-5234 LWallace@otonomy.com
United States
 
NCT01412177
104-201102
Yes
Otonomy, Inc.
Otonomy, Inc.
Not Provided
Study Chair: Carl LeBel, PhD Otonomy, Inc.
Otonomy, Inc.
July 2014

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