OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube...
Otitis Media With EffusionThe purpose of this study is to confirm the effectiveness, safety and tolerability of OTO-201 in the treatment of pediatric subjects with bilateral middle ear effusion who require tympanostomy tube placement.
Postoperative Effects of Intranasal Fentanyl, IV and IM Morphine in Children Undergoing Myringotomy...
Otitis MediaThe purpose of this study is to compare the difference in effect of three clinically common methods of providing pain medication during surgery for ventilating tubes placed for recurring ear infections.The methods are fentanyl dripped in the nose, morphine injected in a muscle, and morphine injected in a vein.
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections...
Acute Otitis MediaThe purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating middle ear infections in children with ear tubes.
A Comparison of Safety and Efficacy of Cefdinir Oral Suspension Versus Azithromycin in Pediatric...
Acute Otitis MediaTo compare the safety and efficacy of cefdinir oral suspension, 7 mg/kg every 12 hours for 5 days, to azithromycin oral suspension 10 mg/kg/day (Day 1) then 5 mg/kg/day (Days 2-5) for a total of 5 days, in children between 6 months and 6 years of age, with AOM.
Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis...
Acute Otitis MediaTo evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
Otitis MediaThe primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5 days in children with acute otitis media (AOM). Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of telithromycin 20 mg/kg qd for 5 days in children with AOM.
Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children
Otitis MediaThis 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. The currently approved regimen is twice daily for 10 days.
A Phase II Study of an Otic Formulation in Treating Peri-Operative Tube Otorrhea
Acute Otitis MediaThe purpose of this study is to determine if an otic formulation is safe and effective in treating peri-operative tube otorrhea.
A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion...
Otitis Media With EffusionThis study is being done to see if reflux of stomach fluid might be a cause of chronic fluid in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole) will increase the rate of resolution of chronic middle ear fluid in children.
A Efficacy Against Otitis Media in Children With 11 Valent Pneumococcal Vaccine
Hepatitis AThe 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 pneumococcal vaccine according to a 3 dose primary vaccination in the first year of life, with booster dose in the second year of life. Prophylactic immunization with pneumococcal conjugate vaccine is compared to placebo (hepatitis A vaccine).