Trial record 4 of 22 for:    meniere

OTO-104 for the Treatment of Meniere's Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Otonomy, Inc.
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.
ClinicalTrials.gov Identifier:
NCT01412177
First received: July 31, 2011
Last updated: August 18, 2014
Last verified: August 2014
  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 2b Study of OTO-104 Given as a Single Intratympanic Injection in Subjects With Unilateral Meniere's Disease

Resource links provided by NLM:


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
Study Start Date: November 2013
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OTO-104 Drug: OTO-104
Single intratympanic injection of 12 mg OTO-104
Placebo Comparator: Placebo 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01412177

Contacts
Contact: Liza Wallace, RN (858) 242-5234 LWallace@otonomy.com

Locations
United States, California
Many sites in US and Canada. Refer to the contact info listed below. Recruiting
San Diego, California, United States
Contact: Arlene Genzel    1-844-MD-STUDY    clinicalstudies@otonomy.com   
United States, Ohio
UC Health Otolaryngology - Head and Neck Surgery Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Jessica Keller    513-558-1719    kellerj4@ucmail.uc.edu   
Principal Investigator: Ravi Samy, MD         
Sponsors and Collaborators
Otonomy, Inc.
Investigators
Study Chair: Carl LeBel, PhD Otonomy, Inc.
  More Information

Additional 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: August 18, 2014
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 September 18, 2014