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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02801370
Other study ID # 201-201609
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date June 2016
Est. completion date December 2016

Study information

Verified date September 2020
Source Otonomy, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201 or Sham-Control (empty syringe) to the external auditory canal of the affected ear(s).


Recruitment information / eligibility

Status Completed
Enrollment 262
Est. completion date December 2016
Est. primary completion date November 2016
Accepts healthy volunteers No
Gender All
Age group 6 Months and older
Eligibility Inclusion Criteria includes, but is not limited to: - Subject is a male or female age 6 months or older - Subject has a clinical diagnosis of unilateral or bilateral acute 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 eczematoid otitis externa - Subject has diabetes mellitus

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
12 mg ciprofloxacin
Single administration of OTO-201
Sham Control
Simulated, single adminstration

Locations

Country Name City State
Canada Call Otonomy call center for trial locations Saskatoon
United States Call Otonomy call center for trial locations San Diego California

Sponsors (1)

Lead Sponsor Collaborator
Otonomy, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects Considered a Clinical Cure at Day 8 Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:
None = 0 Mild = 1 Moderate = 2 Severe = 3
At Day 8 (1 week after dosing)
Secondary Number of Subjects Considered a Clinical Cure at Day 15 Clinical Signs (edema, erythema, otorrhea and otalgia) all had a score of 0 at Day 15. Each sign was graded as follows:
None = 0 Mild = 1 Moderate = 2 Severe = 3
At Day 15 (2 weeks after dosing)
See also
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Not yet recruiting NCT04636957 - A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE) Phase 3
Completed NCT01447017 - A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis Phase 2
Completed NCT01535599 - Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa Phase 3
Completed NCT00750633 - A Phase III Study of an Otic Formulation in Acute Otitis Externa Phase 3
Terminated NCT00945802 - FST-201 In The Treatment of Acute Otitis Externa Phase 3
Completed NCT03196973 - Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa Phase 3
Recruiting NCT01584271 - Study of Ear Comfort Ear Drops to Treat AOE Cases Compared to DexOtic & Otidin(R) Phase 2
Completed NCT02216071 - Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa Phase 3
Completed NCT00961675 - FST-201 in the Treatment of Acute Otitis Externa Phase 3
Completed NCT01535560 - Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa Phase 3