Clinical trials: Otitis
Infections, Streptococcal
Study to Identify and Characterize Bacteria Causing Acute Otitis Media in Young Children in Turkey
The purpose of this study is to identify and characterize the bacteria causing complicated Acute Otitis Media episode in children >= 3 months to < 5 years in Turkey.
- Trial name
- NCT01031329
- Testing
- Tympanocenthesis and urine collection
- Where
- 8 sites in Turkey (Türkiye)
- Sponsor
- GlaxoSmithKline
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
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.
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
Acute Otitis Externa
A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis
The primary objective of this study is to evaluate safety and tolerability of DPK-060 2% ear drops compared to placebo for DPK-060 ear drops in patients with acute external otitis.
- Trial name
- NCT01447017
- Testing
- DPK-060
- Where
- 7 sites in Sweden
- Volunteers
- 69 people
- Sponsor
- DermaGen AB
Otitis Media
Study of the Hummingbird TTS™ Tympanostomy Tube System
The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under…
- Trial name
- NCT03503591
- Testing
- Hummingbird Tympanostomy Tube System
- Where
- 4 sites in United States
- Volunteers
- 109 people
- Sponsor
- Preceptis Medical, Inc.
Upper Respiratory Tract Infections, Rhinopharyngitis
Effect of the Consumption of a Fermented Milk on Common Infections in Adults Submitted to Multi-stressor Situation
This multicentric, randomized, double-blind and controlled study aims to examine the effect of a fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel® = tested product) on the incidence of…
- Conditions
- Upper Respiratory Tract Infections, Rhinopharyngitis, Sore Throat, Sinusitis
- Trial name
- NCT01315418
- Testing
- 1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®), 2-Non fermented dairy product (control)
- Where
- France
- Volunteers
- 239 people, healthy volunteers welcome
- Sponsor
- Danone Global Research & Innovation Center
Otitis Media
Earset Healthy Volunteer Study
The study will recruit healthy volunteers to undergo the Iontophoresis procedure using the Acclarent Iontophoresis System with Earset (IPSES).
- Trial name
- NCT01611246
- Testing
- Iontophoresis System With Earset
- Where
- United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Integra LifeSciences Corporation
Otitis Media
Singapore Tympanostomy Tube Delivery System Study
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis…
- Trial name
- NCT01046877
- Testing
- Tympanostomy Tube Delivery System
- Where
- Singapore
- Volunteers
- 25 people
- Sponsor
- Integra LifeSciences Corporation
CerebroSpinal Fluid (CSF) Leak, Chronic Otitis Media
Cone Beam CT for Diagnosis of Select Otorhinolaryngology (ENT) Indications at Lower Dose
The study objective is to compare the CBCT images generated by the CS 9300 to those generated by conventional CT.
- Conditions
- CerebroSpinal Fluid (CSF) Leak, Chronic Otitis Media, Otospongiosis, Otosclerosis
- Trial name
- CBCT-ENT (NCT01855425)
- Testing
- Radiation
- Where
- 3 sites in United States, Belgium and 1 more
- Volunteers
- 96 people
- Sponsor
- Carestream Health, Inc.
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
Otorrhea
Natural History Study of Incidence of Otorrhea Following Tympanostomy Tube Insertion in Children 6 Months to 12 Years
This study was conducted to describe the time to first incidence of otorrhea post tympanostomy tube insertion.
- Trial name
- NCT01111877
- Where
- United States
- Volunteers
- 1,389 people
- Sponsor
- Alcon Research
Infections, Streptococcal, Streptococcus Pneumoniae
Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A
The aim of this study is to assess the effectiveness of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A) in preventing invasive disease caused by S. pneumoniae or H.
- Trial name
- NCT00839254
- Testing
- Pneumococcal conjugate vaccine Synflorix (GSK1024850A), GSK Biologicals' Engerix TM vaccine (Hepatitis B vaccine), GSK Biologicals' Havrix TM vaccine (Hepatitis A vaccine)
- Where
- 15 sites in Finland
- Volunteers
- 6,181 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Otitis Externa
A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in…
- Trial name
- NCT00980876
- Testing
- Cipro HC, Ciprofloxacin HCl and Hydrocortisone
- Where
- Brazil
- Volunteers
- 224 people
- Sponsor
- Farmoquimica S.A.
Otitis Externa
Performance and Safety of Otinova® Ear Spray
The purpose of this study is to assess the performance and safety of Otinova® Ear Spray when used in the treatment of external otitis symptoms.
- Trial name
- NCT05370209
- Testing
- Otinova® Ear Spray
- Where
- 3 sites in Sweden
- Volunteers
- 28 people
- Sponsor
- Circius Pharma AB
Otitis Media With Effusion, Middle Ear Effusion
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
The study has three objectives: 1. To determine if the device can detect if middle ear fluid is present in children who are scheduled for tube placement (myringotomy) 2.
- Trial name
- NCT01421199
- Testing
- Myringotomy
- Volunteers
- 125 people
- Sponsor
- OtoSonics Inc.
Infections, Streptococcal
COMPAS (Clinical Otitis Media & Pneumonia Study): Pneumonia & Acute Otitis Media (AOM ) Efficacy Study of the Pneumococcal Conjugate Vaccine
This is a study in a large number of healthy children less than 3 years old to measure the efficacy of GlaxoSmithKline (GSK) Biologicals' 10-valent pneumococcal conjugate candidate vaccine (Synflorix vaccine, or GSK1024850A) to…
- Trial name
- NCT00466947
- Testing
- Pneumococcal conjugate vaccine GSK1024850A, Havrix, Engerix-B
- Where
- 22 sites in Argentina, Colombia and 1 more
- Volunteers
- 23,802 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Vertigo
Evaluation of the OtoBand in Subjects With Self-reported Vertigo to Reduce Severity of Vertigo in a Real-world Setting
This study seeks to gather data on the effect of a device, the OtoBand, in participants who have reported symptoms of vertigo, compared to the effect of using one of two sham devices.
- Trial name
- NCT04869020
- Testing
- Otoband
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Otolith Labs
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.