Otitis Media Clinical Trial
Official title:
An 8-Week, Prospective, Multicenter, Open-Label Study of OTO-201 Given as a Single Administration in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
NCT number | NCT02600559 |
Other study ID # | 201-201507 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | October 2015 |
Est. completion date | July 2016 |
Verified date | September 2020 |
Source | Otonomy, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear. The study is designed to evaluate the safety and efficacy of OTO-201 in subjects undergoing TT placement with common concurrent surgeries and any middle ear effusion status.
Status | Completed |
Enrollment | 501 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 17 Years |
Eligibility | Inclusion Criteria includes, but is not limited to: - Subject is a male or female aged 6 months to 17 years, inclusive - Subject has a history of otitis media requiring bilateral tympanostomy tube placement - 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 a history of prior ear or mastoid surgery, not including myringotomy or myringotomy with TT placement - Subject has been designated for any other surgical procedure that would occur concurrently with TT placement, except adenoidectomy, airway endoscopy, nasal endoscopy, and nasal cautery for epistaxis - Subject has a history of sensorineural hearing loss |
Country | Name | City | State |
---|---|---|---|
United States | Email Otonomy Central Contact for Trial Locations | San Diego | California |
Lead Sponsor | Collaborator |
---|---|
Otonomy, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Subjects With Post-surgical Otorrhea | Absence or presence of otorrhea (drainage from the middle ear) | Week 4 | |
Primary | Number of Subjects With Post-surgical Otorrhea | Absence or presence of otorrhea (drainage from the middle ear) | 8 weeks | |
Secondary | Adverse Events | Evaluation of adverse events | Up to Eight Weeks | |
Secondary | Caregiver Burden - Ear Discharge Control | Ear Drop Caregiver Burden Questionnaire at Week 4 | Week 4 | |
Secondary | Caregiver Burden - Ear Discharge Control | Ear Drop Caregiver Burden Questionnaire at Week 8 | Week 8 | |
Secondary | Caregiver Burden - Ear Drops Administration | Ear Drop Caregiver Burden Questionnaire at Week 8 | Week 8 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04016051 -
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
|
Phase 3 | |
Completed |
NCT02452164 -
Family MobilePhone Otoscopy in Diagnostics of Otitis Media
|
N/A | |
Completed |
NCT01199016 -
Effect of Prevnar 13 on Ear Infections in Children
|
Phase 4 | |
Terminated |
NCT00778063 -
Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients
|
N/A | |
Completed |
NCT00195611 -
Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
|
Phase 4 | |
Recruiting |
NCT03722160 -
Clinical Study of the Solo Tympanostomy Tube Device
|
N/A | |
Recruiting |
NCT04447521 -
Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium
|
||
Active, not recruiting |
NCT05127161 -
Broad Implementation of Outpatient Stewardship
|
N/A | |
Completed |
NCT01444391 -
inVENT-visIOn Study
|
N/A | |
Enrolling by invitation |
NCT01437436 -
The Effect of Obesity on Ventilation Tube Insertion
|
N/A | |
Completed |
NCT01003210 -
Homeopathic Ear Drops for Otitis Media Study
|
N/A | |
Completed |
NCT00768534 -
Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media
|
N/A | |
Recruiting |
NCT00393159 -
The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children
|
Phase 4 | |
Completed |
NCT00617682 -
Maternal Immunization To Prevent Infant Otitis Media
|
Phase 1/Phase 2 | |
Withdrawn |
NCT00956748 -
N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media
|
Phase 4 | |
Withdrawn |
NCT01908764 -
Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery
|
Phase 1 | |
Recruiting |
NCT01619462 -
Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children
|
Phase 3 | |
Completed |
NCT02616458 -
The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population
|
N/A | |
Completed |
NCT00044473 -
A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat
|
Phase 3 | |
Completed |
NCT00051753 -
Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
|
Phase 3 |