Clinical trials: Otitis Media in Children
- Condition Otitis Media in Children
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Infections, Streptococcal
Evaluation of a Vaccine for Reducing Ear and Lung Infections in Children
The purpose of this study is to 1) demonstrate the protective efficacy against acute otitis media (AOM), 2) assess safety of the GlaxoSmithKline (GSK) Biologicals' pneumococcal vaccine GSK2189242A in Native American infants aged…
- Trial name
- NCT01545375
- Testing
- Pneumococcal vaccine GSK2189242A, Prevnar 13®, PedvaxHIB®
- Where
- 5 sites in United States
- Volunteers
- 1,806 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Otitis Media, Mastoiditis
Impact of Prevnar 13 on Ear Infections in Children
Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar.
- Trial name
- NCT01272999
- Testing
- No intervention
- Where
- 8 sites in United States
- Volunteers
- 391 people
- Sponsor
- Pfizer
Otitis Media
Effect of Prevnar 13 on Ear Infections in Children
Prevnar (7 valent pneumococcal conjugate vaccine [7vPnC]) has been shown to be effective against ear infections in children. Prevnar 13 is a new vaccine that is similar to Prevnar.
- Trial name
- NCT01199016
- Testing
- Tympanocentesis, Nose/throat swab, Observational
- Where
- 7 sites in United States
- Volunteers
- 239 people
- Sponsor
- Pfizer
Otitis Media With Effusion in Children, Otitis Media Recurrent
Pediatric Pharmacokinetic (PK) Study of EXE844 Otic Suspension in Otitis Media at the Time of Tympanostomy Tube Insertion (OMTT)
The purpose of this study is to describe the pharmacokinetics (PK) of EXE844 Sterile Otic Suspension, 0.3% following a single bilateral ototopical dose in pediatric subjects, immediately after bilateral tympanostomy tube surgery.
- Trial name
- NCT02539654
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Alcon Research
Ear Infection, Otitis Media
In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old
The objective of this study is to evaluate the safety and performance of the Hummingbird® for the placement of ear tubes in children undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.
- Trial name
- NCT03544138
- Testing
- Hummingbird Tympanostomy Tube System (H-TTS)
- Where
- 7 sites in United States
- Volunteers
- 258 people
- Sponsor
- Preceptis Medical, Inc.
Acute Otitis Media
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months
The purpose of this study is to develop a better understanding of the safety, tolerability and efficacy of intranasal OP0201 as an adjunct treatment to oral antibiotics for the treatment of Acute Otitis Media (AOM) in infants and…
- Trial name
- NCT03818815
- Testing
- OP0201, Amoxicillin-clavulanate
- Where
- United States
- Volunteers
- 103 people
- Sponsor
- Novus Therapeutics, Inc
Otitis Media
Tympanostomy Tube Placement in Children in the Office (Inova Study)
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.
- Trial name
- Inova (NCT01496287)
- Testing
- Tube Delivery System (TDS)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Integra LifeSciences Corporation
Acute Otitis Media
Four Arm Safety & Efficacy With Antipyrine and Benzocaine Otic Solution in Children With Acute Otitis Media
The primary objective is to compare the effect of treatment with a combination of ear solutions on the reduction of pain symptoms at 1 hour after dosing in children with acute otitis media.
- Trial name
- NCT02037893
- Testing
- Antipyrine and Benzocaine otic solution, Antipyrine Otic Solution, Benzocaine Otic Solution
- Where
- 10 sites in United States
- Volunteers
- 112 people
- Sponsor
- Currax Pharmaceuticals
Otitis Media With Effusion in Children, Otitis Media Recurrent
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
- Trial name
- NCT02436304
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Volunteers
- 404 people
- Sponsor
- Alcon Research
Otitis Media With Effusion in Children, Otitis Media Recurrent
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT)
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
- Trial name
- NCT02432105
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Volunteers
- 470 people
- Sponsor
- Alcon Research
Acute Otitis Media
Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media
The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) formulation in pediatric…
- Trial name
- NCT00796224
- Testing
- 60 mg/kg azithromycin ER, 30 mg/kg azithromycin IR
- Where
- 2 sites in Costa Rica
- Volunteers
- 38 people
- Sponsor
- Pfizer
OME - Otitis Media With Effusion, AOM - Acute Otitis Media
In-Office Tympanostomy Tube Placement in Children (OTTER)
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.
- Trial name
- OTTER (NCT03323736)
- Testing
- Iontophoresis & tube placement, Tube placement
- Where
- 19 sites in United States, Canada
- Volunteers
- 370 people
- Sponsor
- Tusker Medical
Otitis Media, Infections, Respiratory Tract
Study to Evaluate the Safety and Clinical Efficacy of Augmentin® Extra Strength-600 in Children With Acute Otitis Media in India
Augmentin (ES)-600 is a high-dose amoxicillin/clavulanic acid 14:1 formulation that allows administration at 90/6.4 milligrams (mg)/kilograms (kg)/day in two divided doses.
- Conditions
- Otitis Media, Infections, Respiratory Tract, Respiratory Tract Infections
- Trial name
- NCT04600752
- Testing
- Augmentin (ES)-600
- Where
- 13 sites in India
- Volunteers
- 310 people
- Sponsor
- GlaxoSmithKline