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A 1-Year Safety Study of OTO-104 in Subjects With Unilateral Meniere's Disease Located in United Kingdom

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: NCT02265393
Recruitment Status : Completed
First Posted : October 15, 2014
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Otonomy, Inc.

Brief Summary:
This is a 2-part study of OTO-104 in subjects with unilateral Meniere's disease in the United Kingdom. The first part is a randomized, placebo-controlled study comparing the safety profile of 2 injections of OTO-104 or placebo spaced 3 months apart. The second part is an open-label extension where all subjects will receive an additional 2 intratympanic injections of OTO-104 spaced 3 months apart. Each subject will participate on the study for a total of 1 year.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 6-Month, Prospective, Randomized, Multicenter, Placebo-Controlled Safety Study of OTO-104 Given at 3-Month Intervals by Intratympanic Injection in Subjects With Unilateral Meniere's Disease Followed by a 6-Month Open-Label Extension
Study Start Date : October 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: OTO-104
12 mg OTO-104 (dexamethasone)
Drug: OTO-104
Placebo Comparator: Placebo
OTO-104 vehicle
Drug: Placebo



Primary Outcome Measures :
  1. Safety [ Time Frame: Up to 1 Year ]
    Otoscopy, audiometry, tympanometry, adverse events


Secondary Outcome Measures :
  1. Meniere's Symptom Questionnaire [ Time Frame: Up to 1 Year ]


Information from the National Library of Medicine

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

Inclusion Criteria includes, but is not limited to:

  • Subject has a diagnosis of definite unilateral Meniere's disease.
  • Subject agrees to maintain their current standard of care treatments for Meniere's disease while on-study.

Exclusion Criteria includes, but is not limited to:

  • 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 gentamicin in the affected ear.
  • Subject has a history of drop attacks.
  • Subject has experienced an adverse reaction to intratympanic injection of steroids.

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): NCT02265393


Locations
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United Kingdom
Heatherwood & Wexham Park Hospitals
Berkshire, United Kingdom
Birmingham University Hospital
Birmingham, United Kingdom
BMI The Edgbaston Hospital
Birmingham, United Kingdom
Southmead Hospital Bristol
Bristol, United Kingdom
Oxford University Hospitals
Bucks, United Kingdom
Cambridge University Hospitals
Cambridge, United Kingdom
Dorset County Hospital
Dorset, United Kingdom
Gloucestershire Royal Hospital
Gloucester, United Kingdom
Leicester Royal Infirmary
Leicestershire, United Kingdom
Guy's Hospital and St. Thomas' Hospital
London, United Kingdom
St. George Hospital
London, United Kingdom
Norfolk & Norwich University Hospital
Norfolk, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Sheffield Teaching Hospitals & Sheffield Children's Hospital
Sheffield, United Kingdom
University Hospital of North Staffordshire, Stoke-on-Trent and Stafford General Hospital
Staffordshire, United Kingdom
Sponsors and Collaborators
Otonomy, Inc.
Investigators
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Study Chair: Carl LeBel, PhD Otonomy, Inc.
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Responsible Party: Otonomy, Inc.
ClinicalTrials.gov Identifier: NCT02265393    
Other Study ID Numbers: 104-201403
First Posted: October 15, 2014    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Additional relevant MeSH terms:
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Meniere Disease
Endolymphatic Hydrops
Labyrinth Diseases
Ear Diseases
Otorhinolaryngologic Diseases