Clinical trials: Ear Infection
Hunter Syndrome
Study of Intrathecal Idursulfase-IT Administered in Conjunction With Elaprase® in Pediatric Patients With Hunter Syndrome and Early Cognitive Impairment
Study HGT-HIT-094 is a multicenter study designed to determine the effect on clinical parameters of neurodevelopmental status of monthly IT administration of idursulfase-IT 10 mg for 12 months in pediatric patients with Hunter…
- Trial name
- AIM-IT (NCT02055118)
- Testing
- idursulfase-IT, No IT treatment
- Where
- 9 sites in United States, Australia and 5 more
- Volunteers
- 58 people
- Sponsor
- Shire
Hunter Syndrome
An Observational Study Evaluating Anti-Idursulfase Serum Antibody Response in Hunter Syndrome Patients
The objective of this study is to evaluate the effect of anti-idursulfase antibodies on idursulfase safety (measured by infusion related adverse events) between patients who develop anti-idursulfase antibodies and patients who do…
- Trial name
- NCT00882921
- Testing
- Idursulfase
- Where
- 6 sites in United States, Brazil and 1 more
- Volunteers
- 26 people
- Sponsor
- Shire
Acute Otitis Media
Xylitol Syrup for the Prevention of Acute Otitis Media in Otitis-prone Children
The primary objective of the proposed study is to determine the effectiveness and safety of orally administered viscous-adherent xylitol syrup given in a dose of five grams three times daily for 12 weeks in reducing the incidence…
- Trial name
- NCT01044030
- Testing
- Xylitol syrup
- Where
- 2 sites in United States
- Volunteers
- 326 people
- Sponsor
- Boston Children's Hospital
Otitis Externa
OTO-201 for the Treatment of Otitis Externa
This is a 1-month, multicenter, open-label study in subjects with unilateral otitis externa. Eligible subjects will receive a single dose of 6 mg OTO-201 to the affected ear.
- Trial name
- NCT02511561
- Testing
- OTO-201 (ciprofloxacin)
- Where
- United States
- Volunteers
- 75 people
- Sponsor
- Otonomy, Inc.
Acute Otitis Externa
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE
- Trial name
- NCT03196973
- Testing
- DF289 plus DF277, DF289, DF277
- Where
- Spain
- Volunteers
- 493 people
- Sponsor
- Salvat
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.
Acute Otitis Media
Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media
To determine whether tympanostomy tube placement (TTP) compared with nonsurgical management will meaningfully improve children's acute otitis media (AOM) experience over the succeeding 2 years.
- Trial name
- NCT02567825
- Testing
- Tympanostomy tube placement, Amoxicillin-Clavulanate and/or Ceftriaxone, Ofloxacin Otic
- Where
- 2 sites in United States
- Volunteers
- 250 people
- Sponsor
- Alejandro Hoberman
Otitis Media With Effusion in Children, Otitis Media Recurrent
Safety and Efficacy of EXE844 Otic Suspension in Otitis Media at Time of Tympanostomy Tube Insertion (OMTT) - Study 2
The purpose of this study is to evaluate EXE844 plus tympanostomy tubes compared to tympanostomy tubes only based on sustained clinical cure at end-of-therapy (EOT).
- Trial name
- NCT02436304
- Testing
- EXE844 Sterile Otic Suspension, 0.3%, Tympanostomy Tube Insertion
- Volunteers
- 404 people
- Sponsor
- Alcon Research
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
- NCT01949142
- Testing
- OTO-201
- Where
- United States
- Volunteers
- 266 people
- Sponsor
- Otonomy, Inc.
Acute Otitis Externa
Safety and Efficacy Evaluation of Topical AL-60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa
The purpose of this study was to demonstrate the superiority of AL-60371, 0.3% Otic Suspension relative to AL-60371 Vehicle based on clinical cures at test-of-cure (TOC) for the treatment of acute otitis externa (AOE).
- Trial name
- NCT01535599
- Testing
- AL-60371, 0.3% Otic Suspension, AL-60371 Vehicle
- Volunteers
- 768 people
- Sponsor
- Alcon Research
Acute Otitis Media
Acute Otitis Media (AOM) Therapy Trial in Young Children
The purpose of this study is to learn whether or not all children with ear infections (acute otitis media or AOM) should be treated with antibiotics.
- Trial name
- NCT00377260
- Testing
- amoxicillin-clavulanate
- Where
- United States
- Volunteers
- 291 people
- Sponsor
- University of Pittsburgh
Acute Otitis Media, Otitis Media
A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)
- Conditions
- Acute Otitis Media, Otitis Media, Ear Infection
- Trial name
- NCT00189462
- Testing
- Montelukast
- Where
- 2 sites in United States
- Volunteers
- 99 people
- Sponsor
- Deborah Gentile
Cleft Palate, Tube Disorders Eustachian
Exercises for Improving Soft Palate and Eustachian Tube Function in Children With Ear Tubes With or Without Cleft Palate
Elevation of the soft palate (the soft part of the roof of the mouth) during swallowing helps the Eustachian tube to open and keep the ear healthy.
- Conditions
- Cleft Palate, Tube Disorders Eustachian, Velopharyngeal Incompetence Due to Cleft Palate, Velopharyngeal Insufficiency
- Trial name
- NCT03868891
- Testing
- EMST150
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- Noel Jabbour
Hunter Syndrome
An Extension Study of HGT-HIT-045 Evaluating Long-Term Safety and Clinical Outcomes of Idursulfase-IT in Conjunction With Elaprase in Pediatric Participants With Hunter Syndrome and Cognitive Impairment
This extension study of HGT-HIT-045 is designed to collect long-term safety data in pediatric participants with Hunter syndrome and cognitive impairment who are receiving intrathecal (IT) idursulfase-IT and intravenous (IV)…
- Trial name
- NCT01506141
- Testing
- Idursulfase-IT, Elaprase
- Where
- 9 sites in United States, Canada and 1 more
- Volunteers
- 15 people
- Sponsor
- Takeda
Otitis Media
inVENT-In-Office Study
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.
- Trial name
- inVENT-IO (NCT01324271)
- Testing
- Acclarent Tympanostomy Tube Delivery system (TTDS)
- Where
- United States
- Volunteers
- 85 people
- Sponsor
- Integra LifeSciences Corporation
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
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
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
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, 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