Clinical trials: Otitis Media
Infections, Streptococcal
Study to Identify and Characterize the Bacteria Causing Acute Otitis Media Episodes in Young Children in Saudi Arabia
The purpose of the study is to identify the bacterial aetiology of acute otitis media episodes in young children aged ≥ 3 months to < 5 years in Saudi Arabia.
- Trial name
- NCT01204385
- Testing
- Sample collection
- Where
- Saudi Arabia
- Volunteers
- 66 people
- Sponsor
- GlaxoSmithKline
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 Media
Clinical Evaluation of the OtoSight
The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media.
- Trial name
- NCT03890107
- Testing
- OtoSight Middle Ear Scope
- Where
- 2 sites in United States
- Volunteers
- 110 people
- Sponsor
- PhotoniCare, Inc.
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
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
Otitis Media
Pazufloxacin Mesilate Ear Drops Clinical Trial Protocol
To investigate the safety, tolerance, dynamic percolation model of single dose usage pazufloxacin mesilate ear drops for patients with acute suppurative otitis media or chronic suppurative otitis media
- Trial name
- NCT02592096
- Testing
- 0.1% Pazufloxacin Mesilate Ear Drops, 0.3% Pazufloxacin Mesilate Ear Drops, 0.5% Pazufloxacin Mesilate Ear Drops
- Where
- China
- Volunteers
- 32 people
- Sponsor
- Lee's Pharmaceutical Limited
Tinnitus
Caroverin and Inner Ear Diseases
This trial is a randomized, double blind, placebo controlled study on patients suffering from inner ear diseases with tinnitus as a principal symptom.
- Trial name
- NCT01174979
- Testing
- Caroverin
- Where
- Austria
- Volunteers
- 170 people
- Sponsor
- Phafag AG
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.
Infections, Streptococcal
Healthcare Seeking Behaviour of Primary Caregivers for Acute Otitis Media (AOM) in Children Aged 6 Months to Less Than 30 Months in Panama
The study is a survey aiming to describe the healthcare seeking behaviour of primary caregivers when their child aged 6 months to less than 30 months was suspected to have an episode of acute otitis media in Panama.
- Trial name
- NCT01793857
- Testing
- Data collection
- Where
- 13 sites in Panama
- Volunteers
- 1,330 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
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, Otorrhea
A Clinical Trial of YH1177 in Patients With Otitis Media and Otorrhea
In patients with otitis media presenting with otoscopy-confirmed otorrhea who had tympanostomy tube insertion or tympanic perforation, to evaluate the safety, tolerability, and the proportion of patients with cessation of…
- Trial name
- NCT02817347
- Testing
- piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%, piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%, piperacillin 2% + tazobactam 0.25%
- Where
- South Korea
- Volunteers
- 135 people
- Sponsor
- Yuhan Corporation
Otitis Media With Effusion, Acute Otitis Media
Evaluation of the Tympanostomy Tube Delivery System
The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
- Trial name
- inVENT-OR (NCT01202578)
- Testing
- tympanostomy tube
- Where
- 4 sites in United States
- Volunteers
- 53 people
- Sponsor
- Integra LifeSciences Corporation
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
Pain, Acute Otitis Media
Phase III Study Evaluating Topical Benzocaine for Treatment of Acute Otitis Media in Children
The Phase III study is designed to assess the safety, tolerability, and efficacy of Topical Benzocaine in children, ages 5 to 12 years, presenting with Acute Otitis Media-associated ear pain.
- Trial name
- NCT03116737
- Testing
- Benzocaine Otic Solution
- Where
- United States
- Volunteers
- 141 people
- Sponsor
- Lachlan Pharma Holdings
Acute Otitis Media (AOM)
Safety and Efficacy of wSp Vaccine in Young Children
The goal of this clinical trial is to evaluate whether the wSp vaccine can prevent nasopharyngeal colonization by pneumococcal bacteria in healthy young children who have received routine PCV15 or PCV20 vaccination.
- Trial name
- wSp005 (NCT07216430)
- Testing
- wSp vaccine, Saline (0.9% NaCl)
- Where
- 7 sites in United States
- Volunteers
- 320 people, healthy volunteers welcome
- Sponsor
- Serum Life Science Europe GmbH
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
inVENT-visIOn Study
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an…
- Trial name
- inVENT-visIOn (NCT01444391)
- Testing
- Tympanostomy tube placement (Acclarent iontophoresis device)
- Where
- United States
- Volunteers
- 42 people
- Sponsor
- Integra LifeSciences Corporation
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.
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.
Otitis Media
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5 days in children with acute otitis media (AOM).
- Trial name
- NCT00638534
- Testing
- Telithromycin (HMR3647)
- Where
- Japan
- Volunteers
- 56 people
- Sponsor
- Sanofi