Dose Ranging Study of OTO-201 in AOMT
NCT02719158 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 95
Last updated 2020-10-19
Summary
Dose Ranging Study of OTO-201 in AOMT
Conditions
- Acute Otitis Media
- AOMT
Interventions
- DRUG
-
6 mg ciprofloxacin
Single administration of OTO-201
- DRUG
-
12 mg ciprofloxacin
Single administration of OTO-201
- OTHER
-
Sham
Sponsors & Collaborators
-
Otonomy, Inc.
lead INDUSTRY
Principal Investigators
-
Carl LeBel, PhD · Otonomy, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 6 Months
- Max Age
- 17 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-02-29
- Primary Completion
- 2016-06-30
- Completion
- 2016-07-31
Countries
- United States
Study Locations
More Related Trials
-
A Phase III Study of Ciprofloxacin Plus Fluocinolone in Acute Otitis Externa (AOE)
NCT04636957 ·Status: UNKNOWN ·Phase: PHASE3
-
Antimicrobial Stewardship in Community Pharmacy
NCT04219553 ·Status: COMPLETED ·Phase: NA
-
Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance
NCT01511107 ·Status: TERMINATED ·Phase: PHASE2
-
Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
NCT01244581 ·Status: COMPLETED ·Phase: PHASE3
-
A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media
NCT00276042 ·Status: COMPLETED ·Phase: PHASE2
-
Comparison of Amoxicillin and Amoxicillin + Clavulanic Acid in Treating Acute Otitis Media in Children
NCT06895135 ·Status: NOT_YET_RECRUITING ·Phase: NA
-
Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children
NCT02935374 ·Status: COMPLETED ·Phase: PHASE4
-
Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children
NCT00781521 ·Status: COMPLETED ·Phase: PHASE3
-
Acute Otitis Media (AOM) Therapy Trial in Young Children
NCT00377260 ·Status: COMPLETED ·Phase: PHASE4
-
Amoxicillin Clavulanate in Treatment of Acute Otitis Media
NCT00299455 ·Status: UNKNOWN ·Phase: PHASE4
-
Long-term Antibiotics for Treatment and Prevention of Otitis Media in Aborignal Children
NCT00539149 ·Status: COMPLETED ·Phase: PHASE4
-
Zmax Pediatric Vs Adult Concentration For The Treatment Of Acute Otitis Media
NCT00360100 ·Status: COMPLETED ·Phase: PHASE3
-
Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media
NCT00645203 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
The Microbiome Variability and Antibiotic Resistance of Chronic Suppurative Otitis
NCT03456739 ·Status: UNKNOWN
-
Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Saudi Arabia
NCT01204385 ·Status: COMPLETED
-
N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media
NCT00956748 ·Status: WITHDRAWN ·Phase: PHASE4
-
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
NCT01404611 ·Status: COMPLETED ·Phase: PHASE3
-
Comparative Study to Evaluate the Efficacy and Safety of Telithromycin Given Once Daily Versus Cefuroxime Axetil Given Twice Daily in Children With Middle Ear Infections
NCT00174811 ·Status: TERMINATED ·Phase: PHASE3
-
Ciprofloxacin Versus Azithromycin for Children Hospitalised With Dysentery
NCT03854929 ·Status: COMPLETED ·Phase: PHASE4
-
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Cefiderocol in Hospitalized Pediatric Participants
NCT04215991 ·Status: COMPLETED ·Phase: PHASE2
-
A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric Subjects With Acute Otitis Media
NCT00645112 ·Status: COMPLETED ·Phase: PHASE4
-
N-of-1 Trials of Interventions to Improve Decision-making for Antibiotic Use
NCT05451836 ·Status: COMPLETED ·Phase: NA
-
TELI COM - Telithromycin in Children With Otitis Media
NCT00315003 ·Status: TERMINATED ·Phase: PHASE3
-
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media
NCT02630992 ·Status: COMPLETED ·Phase: PHASE3
-
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
NCT00044473 ·Status: COMPLETED ·Phase: PHASE3