Clinical trials: Otitis
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, Acute Otitis Externa
Pediatric Emergency Department Smartphone Otoscope Study (PED-Oto)
Acute otitis media (AOM), defined as acute inflammation in the middle ear, is a leading cause of health encounters and antimicrobial prescriptions in children worldwide.
- Trial name
- NCT02918773
- Testing
- Smartphone otoscope, Conventional otoscope
- Where
- 2 sites in United States
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- Emory University
Pulmonary Disease, Chronic Obstructive, Bronchospasm
Prophylactic Efficacy of Relenza Against Influenza A and B
In response to the European regulatory authorities, GSK is conducting a post-marketing observational study to assess the efficacy of Relenza when used as prophylaxis against influenza. SPECIFIC AIMS 1.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Bronchospasm, Influenza, Human, Asthma
- Trial name
- NCT01156701
- Testing
- Receiving a prescription of Relenza for prophylaxis, No prophylaxis with Relenza
- Volunteers
- 171,705 people
- Sponsor
- GlaxoSmithKline
Acute Otitis Media
Ear Drops for Children With Otitis Media
The purpose of this study is to determine if a commercially available homeopathic ear drop preparation is effective in reducing symptoms in children 6 months - 11 years old with acute otitis media.
- Trial name
- NCT00622518
- Testing
- Hyland's earache drops
- Where
- United States
- Volunteers
- 119 people
- Sponsor
- University of Washington
Acute Otitis Externa
Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Otic Solution in the Treatment of Acute Otitis Externa
This is a phase Ⅲ, multicenter, randomized, evaluator-blinded, parallel-group, active-controlled study to assess the efficacy and safety of ciprofloxacin 0.3% plus fluocinolone acetonide 0.025% otic solution vs ciprofloxacin 0.3%…
- Trial name
- NCT04636957
- Testing
- Ciprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic Solution, Ciprofloxacin 0.3% solution
- Where
- China
- Volunteers
- 600 people
- Sponsor
- Lee's Pharmaceutical Limited
Acute Otitis Media
Efficacy of Short-Course Antimicrobial Treatment for Children With Acute Otitis Media and Impact on Resistance
The investigators will study whether, in young children with acute otitis media (AOM), shortening length of antibiotic treatment as a strategy for reducing antimicrobial resistance provides satisfactory clinical outcome.
- Trial name
- NCT01511107
- Testing
- Amoxicillin-Clavulanate, 10 days, Amoxicillin-Clavulanate, 5 days
- Where
- 2 sites in United States
- Volunteers
- 520 people
- Sponsor
- Alejandro Hoberman
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
Otitis Media
Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes
This is an 8-week, multicenter, open-label study in which eligible subjects with a history of otitis media requiring TT placement will receive 6 mg OTO-201 to each ear.
- Trial name
- NCT02600559
- Testing
- OTO-201 (ciprofloxacin)
- Where
- United States
- Volunteers
- 501 people
- Sponsor
- Otonomy, Inc.
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
OTO-201 for the Treatment of Middle Ear Effusion in Pediatric Subjects Requiring Tympanostomy Tube Placement
The 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.
- Trial name
- NCT01949155
- Testing
- OTO-201
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Otonomy, Inc.
Acute Otitis Externa, Swimmer's Ear
Phase 3 Study of OTO-201 in Acute Otitis Externa
This is a prospective, randomized, double-blind, sham-controlled, multicenter, Phase 3 study in which eligible subjects with acute otitis externa (AOE) will be randomized to receive a single administration of either 12 mg OTO-201…
- Trial name
- NCT02801370
- Testing
- 12 mg ciprofloxacin
- Where
- 2 sites in United States, Canada
- Volunteers
- 262 people
- Sponsor
- Otonomy, Inc.
Acute Otitis Externa
Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension (Ciprodex®, Alcon) in the treatment of…
- Trial name
- NCT02216071
- Testing
- Ciprodex®, EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension
- Where
- 48 sites in United States, Puerto Rico
- Volunteers
- 499 people
- Sponsor
- Exela Pharma Sciences, LLC.
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
Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion
This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).
- Trial name
- inVENT2 (NCT02150044)
- Testing
- Acclarent Tympanostomy Tube Delivery System (TTDS).
- Where
- United States
- Volunteers
- 29 people
- Sponsor
- Integra LifeSciences Corporation
Otitis Media
Hummingbird TTS Ear Tube Delivery Study
The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.
- Trial name
- NCT02165384
- Testing
- Ear tube placement with the Hummingbird TTS
- Where
- 4 sites in United States
- Volunteers
- 199 people
- Sponsor
- Preceptis Medical, Inc.
Hunter Syndrome
A Safety and Dose Ranging Study of Idursulfase (Intrathecal) Administration Via an Intrathecal Drug Delivery Device in Pediatric Patients With Hunter Syndrome Who Have Central Nervous System Involvement and Are Receiving Treatment With Elaprase®
Elaprase (idursulfase), a large molecular protein, is not expected to cross the blood brain barrier at therapeutic levels when administered intravenously.
- Trial name
- NCT00920647
- Testing
- Control, Idursulfase IT (1 mg), Idursulfase IT (10 mg)
- Where
- 3 sites in United States, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Shire
Otitis Media With Effusion
Clinical Study of the Tympanostomy Tube Delivery System
The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such…
- Trial name
- inVENT (NCT00939796)
- Testing
- Acclarent Tympanostomy Tube Delivery System
- Where
- 2 sites in United States
- Volunteers
- 16 people
- Sponsor
- Integra LifeSciences Corporation
Acute Otitis Media, AOMT
Open-Label Study of OTO-201 for Treatment of AOMT
This is a 1-month, prospective, multicenter, open-label study in pediatric subjects with either unilateral or bilateral acute otitis media with tympanostomy tubes (AOMT).
- Trial name
- NCT02408796
- Testing
- OTO-201
- Where
- 5 sites in United States
- Volunteers
- 39 people
- Sponsor
- Otonomy, Inc.
Influenza, Otitis Media
Evaluation of Moderate to Severe Influenza Outcomes in Children
The purpose of this study was to determine whether moderate-severe endpoints (including high fever, lower respiratory tract disease, acute otitis media, or serious extra-pulmonary complications) were predictive of…
- Conditions
- Influenza, Otitis Media, Lower Resp Tract Infection, Encephalitic Infection
- Trial name
- M2SFlu (NCT02979626)
- Testing
- Respiratory nasal swab
- Where
- 2 sites in United States
- Volunteers
- 1,478 people
- Sponsor
- University of Colorado, Denver
Acute Otitis Media, AOMT
Dose Ranging Study of OTO-201 in AOMT
Dose Ranging Study of OTO-201 in AOMT
- Trial name
- NCT02719158
- Testing
- 6 mg ciprofloxacin, 12 mg ciprofloxacin
- Where
- United States
- Volunteers
- 95 people
- Sponsor
- Otonomy, Inc.