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Trial record 10 of 433 for:    OTITIS

OTO-201 for the Treatment of Otitis Externa

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. Identifier: NCT02511561
Recruitment Status : Completed
First Posted : July 30, 2015
Last Update Posted : January 25, 2016
Information provided by (Responsible Party):
Otonomy, Inc.

Brief Summary:
This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear. The study is designed to characterize safety, procedural factors and clinical effect of OTO-201 administered in subjects with otitis externa.

Condition or disease Intervention/treatment Phase
Otitis Externa Drug: OTO-201 (ciprofloxacin) Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A 1-Month, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration for Treatment of Otitis Externa
Study Start Date : July 2015
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 0.1 mL OTO-201
Drug: OTO-201 (ciprofloxacin)
Experimental: 0.2 mL OTO-201
Drug: OTO-201 (ciprofloxacin)
Experimental: 0.4 mL OTO-201
Drug: OTO-201 (ciprofloxacin)

Primary Outcome Measures :
  1. Safety as assessed by adverse events [ Time Frame: Up to 1 month ]
    Evaluation of adverse events

  2. Safety as assessed by otoscopic exams [ Time Frame: Up to 1 month ]
    Evaluation of otoscopic exams

  3. Feasibility of administration [ Time Frame: Day1 ]

Secondary Outcome Measures :
  1. Clinical effect as assessed signs and symptoms of otitis externa [ Time Frame: Up to Two Weeks ]
    Assessment of signs (edema, erythema, otorrhea) and symptoms (otalgia, tenderness)

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria includes, but is not limited to:

  • Subject is a male or female aged 6 months to 80 years, inclusive
  • Subject has a clinical diagnosis of unilateral otitis externa
  • Subject or subject's caregiver is willing to comply with the protocol and attend all study visits

Exclusion Criteria includes, but is not limited to:

  • Subject has tympanic membrane perforation
  • Subject has a history of known immunodeficiency disease
  • Subject has fungal otitis externa, based on clinical signs

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 identifier (NCT number): NCT02511561

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United States, California
Email Otonomy Central Contact for Trial Locations
San Diego, California, United States, 92121
Sponsors and Collaborators
Otonomy, Inc.
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Study Chair: Carl LeBel, PhD Otonomy, Inc.

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Responsible Party: Otonomy, Inc. Identifier: NCT02511561     History of Changes
Other Study ID Numbers: 201-201506
First Posted: July 30, 2015    Key Record Dates
Last Update Posted: January 25, 2016
Last Verified: January 2016
Keywords provided by Otonomy, Inc.:
Otitis externa
Swimmer's ear
Ear infection
Additional relevant MeSH terms:
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Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors