Acute Otitis Media Clinical Trial
Official title:
Safety and Efficacy of a Topical Otic Formulation in the Treatment of Peri-Operative Tube Otorrhea
Verified date | November 2012 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.
Status | Completed |
Enrollment | 303 |
Est. completion date | January 2009 |
Est. primary completion date | January 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 6 Months to 12 Years |
Eligibility |
Inclusion Criteria: - 6 months to 12 years old - Diagnosed with recurrent acute otitis media or chronic otitis media with effusion - Must be first set of ear tubes. - Patient may not have had any other previous otologic-related surgery. - Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube - Patient may not have existing perforation of the eardrum. - Patient must not require another surgical procedure other than myringotomy and tube insertion. - Patient may not be a menarchal female - Diabetic patients are not eligible - Patient may not have any disease or condition that would negatively affect the conduct of the study - Patient may not require any other systemic antimicrobial therapy during the study. - Patient must meet certain medication washouts to be eligible - Analgesic use (other than acetaminophen) is not allowed - Patient may not be pre-disposed to neurosensory hearing loss - Other protocol-defined inclusion criteria may apply Exclusion Criteria: - Age - Other protocol-defined exclusion criteria may apply |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to cessation of otorrhea as recorded by the parent or guardian via a patient diary | From baseline | No | |
Secondary | Clinical cures at each visit | From baseline | No | |
Secondary | Absence of otorrhea at each visit | From baseline | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02092454 -
Study to Assess the Safety and Efficacy of Benzocaine for Pain Relief in Children Presenting With Acute Otitis Media
|
Phase 2 | |
Completed |
NCT01202578 -
Evaluation of the Tympanostomy Tube Delivery System
|
Phase 2/Phase 3 | |
Withdrawn |
NCT00502450 -
Is There Hearing Loss After Acute Mastoiditis
|
N/A | |
Completed |
NCT04296448 -
Evaluation of Cellphone Based Otoscopy in Pediatric Patients
|
N/A | |
Terminated |
NCT05651633 -
Analgesic Ear Drops for Children With Acute Otitis Media
|
Phase 3 | |
Completed |
NCT01941381 -
Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?
|
||
Completed |
NCT02345447 -
Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence
|
Phase 3 | |
Recruiting |
NCT01214538 -
Assessment of the Natural Antibody Response to Pneumococcal Surface Proteins During Acute Otitis Media in Children
|
N/A | |
Completed |
NCT03614117 -
Effect of a New Probiotic Strain on Recurrent Acute Otitis Media in Children (PROMAR)
|
N/A | |
Recruiting |
NCT06027593 -
Using Electronically Derived Automated Reports of Appropriate Antibiotic Use to Inform Stewardship Interventions
|
N/A | |
Completed |
NCT02918773 -
Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
|
N/A | |
Completed |
NCT02567747 -
Vaccination Impact Against Pneumococcal Disease on Acute Otitis Media Morbidity in Colombian Children < 5 Years of Age
|
||
Completed |
NCT02935374 -
Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children
|
Phase 4 | |
Completed |
NCT02567825 -
Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
|
N/A | |
Completed |
NCT02037893 -
Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
|
Phase 2 | |
Completed |
NCT00377260 -
Acute Otitis Media (AOM) Therapy Trial in Young Children
|
Phase 4 | |
Completed |
NCT00645112 -
A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
|
Phase 4 | |
Completed |
NCT00368823 -
A Trial of Point of Care Information in Ambulatory Pediatrics
|
Phase 3 | |
Completed |
NCT01272999 -
Impact of Prevnar 13 on Ear Infections in Children
|
||
Completed |
NCT01031082 -
Study to Identify and Characterize Bacteria Causing Acute Otitis Media in South African Children
|
N/A |