Clinical trials: Otitis Media Acute
Barotrauma;Ear, OME - Otitis Media With Effusion
Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)
A prospective, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula iontophoresis and tube delivery systems for adults in an office setting.
- Conditions
- Barotrauma;Ear, OME - Otitis Media With Effusion, AOM - Acute Otitis Media, Eustachian Tube Dysfunction
- Trial name
- ADEPT (NCT03197558)
- Testing
- Tymbion Iontophoresis and Tube Delivery System (TDS)
- Where
- 8 sites in United States
- Volunteers
- 30 people
- Sponsor
- Tusker Medical
Otitis Media, Otitis Media With Effusion
Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media
The aim of this study is to assess in France the impact of Prevenar on the possible evolution of the pneumococcal serotypes distribution and antibiotic resistance in NP samples of children with AOM.
- Conditions
- Otitis Media, Otitis Media With Effusion, Pneumococcal Infections
- Trial name
- NCT00195611
- Testing
- Prevenar
- Where
- 35 sites in France
- Volunteers
- 3,293 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
Acute Otitis Media
Evaluation of Safety and Reduction of Ear Pain in Adults With Acute Otitis Media and Reduction of Ear Pain in Adults With Acute Otitis Media
The purpose of this study is to evaluate the Safety and Reduction of Ear Pain in Adults with Acute Otitis Media.
- Trial name
- NCT03766373
- Testing
- Drug: OP0201 20mg
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- Novus Therapeutics, Inc
Acute Otitis Media, Chronic Otitis Media
Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus
This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine solution for provision of tympanic membrane…
- Conditions
- Acute Otitis Media, Chronic Otitis Media, Recurrent Acute Otitis Media
- Trial name
- IONTO (NCT00941993)
- Testing
- Iontophoresis System (Acclarent)
- Where
- United States
- Volunteers
- 109 people
- Sponsor
- Integra LifeSciences Corporation
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
A Trial to Evaluate Faropenem Medoxomil in the Treatment of Acute Otitis Media
The study will be conducted in infants and children with acute otitis media, 6 months to less than 7 years old, in Costa Rica and Israel.
- Trial name
- NCT00276042
- Testing
- Faropenem Medoxomil
- Where
- 2 sites in Costa Rica, Israel
- Volunteers
- 328 people
- Sponsor
- Replidyne
Infections, Streptococcal
To Evaluate the Incidence of Acute Otitis Media in Children in Five East European Countries
The aim of this study is to provide baseline acute otitis media data in East European countries.
- Trial name
- NCT01365390
- Testing
- Data collection (Retrospective), Data collection (Prospective)
- Where
- 25 sites in Estonia, Lithuania and 3 more
- Volunteers
- 2,258 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Otitis Media, Otitis Media
Impact of Pneumococcal Conjugate Vaccines on Otitis Media and Acute Otitis Media in Swedish Children
The goal of this study is to look at the effect of pneumococcal conjugate vaccines (PCV) on physician-diagnosed otitis media (OM) and acute otitis media (AOM) incidence in Swedish children by collecting and analyzing patient…
- Trial name
- NCT02742753
- Testing
- Data collection
- Where
- Sweden
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Otitis Media
Phase 3 Study to Compare the Efficacy and Safety of AR01 to a Placebo Solution for Relief of Pain in Acute Otitis Media
Children ages 2 months to less than 19 years old, who have been diagnosed with a middle ear infection may receive either medicated ear drops (AR01) or glycerin (placebo) ear drops.
- Trial name
- AR01006 (NCT02044341)
- Testing
- AR01, Glycerin ear drops
- Where
- 29 sites in United States
- Volunteers
- 304 people
- Sponsor
- Arbor Pharmaceuticals, Inc.
Otitis Media in Patients With Tympanostomy Tubes
Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes
The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the already-marketed formulation CIPRODEX®…
- Trial name
- NCT01994642
- Testing
- Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension, CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)
- Where
- 23 sites in United States
- Volunteers
- 203 people
- Sponsor
- Par Pharmaceutical, Inc.
Infections, Streptococcal, Streptococcus Pneumoniae
Evaluation of Effectiveness of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A Against Invasive Disease
The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), administered according to different vaccination schedules, against invasive disease caused by S.
- Trial name
- FinIP (NCT00861380)
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine), GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)
- Where
- Finland
- Volunteers
- 41,188 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Hepatitis A
A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine
The purpose of this study is to assess the efficacy in young children in preventing acute otitis media due to vaccine serotype pneumococcal or non typable Hemophilus influenza, following immunization with an 11-valent…
- Trial name
- NCT00119743
- Testing
- undecavalent pneumococcal-protein D conjugate vaccine
- Where
- 41 sites in Czechia, Slovakia
- Volunteers
- 5,000 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Acute Otitis Media
Safety and Efficacy of Moxidex Otic
The purpose of this study is to determine if Moxidex otic solution is safe and effective in treating middle ear infections in patients with ear tubes.
- Trial name
- NCT01071902
- Testing
- Moxidex otic solution, Moxifloxacin otic solution, Vehicle
- Where
- United States
- Volunteers
- 400 people
- Sponsor
- Alcon Research
Pain, Otitis Media
Study of FAECC Scale (Modified FLACC) to Evaluate Ear Pain in Children With Acute Otitis Media
This study is to assess the reliability and validity of the FAECC scale to evaluate pain associated with acute otitis media in children aged 2 months to 5 years.
- Trial name
- NCT01588535
- Testing
- benzocaine
- Where
- 15 sites in United States
- Volunteers
- 38 people
- Sponsor
- Arbor Pharmaceuticals, Inc.
Infections, Streptococcal
Study to Characterize and Identify Bacteria Causing Acute Otitis Media in Young Egyptian Children
The purpose of this epidemiological study is to identify and characterize the bacteria causing Acute Otitis Media episodes in children aged >= 3 months to < 5 years in Egypt.
- Trial name
- NCT01160055
- Testing
- Middle ear fluid and urine.
- Sponsor
- GlaxoSmithKline
Acute Otitis Media (AOM)
V114 and Acute Otitis Media (V114-032/PNEU-ERA)
The primary objective is to evaluate V114 in the prevention of vaccine-type acute otitis media (VT-AOM) and the safety of V114 with respect to the proportion of participants with serious adverse events (SAEs) through completion…
- Trial name
- NCT04193215
- Testing
- V114, Pediatric vaccines
- Where
- 13 sites in Thailand
- Volunteers
- 7,119 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Otitis Media
Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children
This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes.
- Trial name
- NCT00781521
- Testing
- ofloxacin otic solution 0.3%
- Volunteers
- 96 people
- Sponsor
- Daiichi Sankyo
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
Acute Otitis Media
Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora
The purpose of this observational study was to evaluate the effects of a topical fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media through Tympanostomy Tubes (AOMT) on selected bacterial…
- Trial name
- NCT01027494
- Testing
- Ciprofloxacin 0.3% and dexamethasone 0.1% otic suspension
- Where
- United States
- Volunteers
- 318 people, healthy volunteers welcome
- Sponsor
- Alcon Research
Otitis Media
Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media
The purpose of this study is to demonstrate non-inferiority of levofloxacin compared with amoxicillin/clavulanate on the clinical response at the end of therapy in infants and children who have recurrent and/or persistent acute…
- Trial name
- NCT00051753
- Testing
- levofloxacin; amoxicillin/clavulanate
- Volunteers
- 1,643 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.