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Otitis clinical trials

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NCT ID: NCT00961675 Completed - Clinical trials for Acute Otitis Externa

FST-201 in the Treatment of Acute Otitis Externa

Start date: August 31, 2009
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This study will be conducted at one site, the Lyndon B. Johnson (LBJ) Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.

NCT ID: NCT00956748 Withdrawn - Otitis Media Clinical Trials

N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media

Start date: November 29, 2019
Phase: Phase 4
Study type: Interventional

Chronic suppurative otitis media (CSOM) can be particularly difficult to treat as a number of patients do not respond to routine antibiotic or surgical treatments. The current treatment involves administering combination antibiotic anti-inflammatory ear drops such as Ciprodex (ciprofloxacin 0.3% / dexamethasone 0.1%). Although most patients experience a relief of symptoms, a fraction of patients remain refractory to treatment. Recent findings suggest that the addition of N-acetylcysteine (0.5-2%) to Ciprodex is a superior treatment for otitis media with effusion compared to the use of Ciprodex alone.

NCT ID: NCT00945802 Terminated - Clinical trials for Acute Otitis Externa

FST-201 In The Treatment of Acute Otitis Externa

Start date: July 31, 2009
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.

NCT ID: NCT00945646 Terminated - Clinical trials for Acute Fungal Otitis Externa

FST-201 In The Treatment of Acute Fungal Otitis Externa

Start date: July 31, 2009
Phase: Phase 3
Study type: Interventional

The objective of this study is to evaluate the efficacy of FST-201 compared to vehicle in the treatment of acute fungal otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute fungal otitis externa.

NCT ID: NCT00941993 Completed - Acute Otitis Media Clinical Trials

Anesthetic Effect of Lidocaine/Epinephrine Solution Delivered Via Iontophoresis to External Auditory Apparatus

IONTO
Start date: April 2008
Phase: N/A
Study type: Interventional

This is a non-randomized, multicenter, prospective, clinical study intended to evaluate the effectiveness of a method for iontophoretic delivery of a buffered lidocaine/epinephrine solution for provision of tympanic membrane anesthesia in patients who are indicated for an ear procedure requiring penetration of the tympanic membrane, including, but not limited to, myringotomy, tympanocentesis with culture or tympanostomy with tube placement.

NCT ID: NCT00939796 Completed - Clinical trials for Otitis Media With Effusion

Clinical Study of the Tympanostomy Tube Delivery System

inVENT
Start date: March 2009
Phase: N/A
Study type: Interventional

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 treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).

NCT ID: NCT00872209 Completed - Clinical trials for Otorhinolaryngologic Diseases

Safety and Efficacy Study of Foam Otic Cipro Compared to a Standard Solution ( Ciloxan - Alcon Labs ) to Treat Acute Otitis Externa

Start date: May 2009
Phase: Phase 1/Phase 2
Study type: Interventional

The purpose of this study is to assess the Safety and Efficacy of Foam Otic Cipro, a novel medication developed to treat Acute Diffuse Otitis Externa of bacterial origin. The working hypothesis is that Foam Otic Cipro is as effective as registered ear drops.

NCT ID: NCT00847756 Active, not recruiting - Otitis Media Clinical Trials

Host-pathogen Interaction in Otitis Media

OMVac
Start date: April 2008
Phase: N/A
Study type: Observational

Otitis Media (OM) is one of the most frequent diseases in childhood and the primary reason for children to visit a physician. In many countries it is the most common reason to prescribe antibiotics leading to increased drug-resistance of the causative agents, or to undergo surgery. Costs for general health care are expanding, and are estimated to be 3-5 billion dollar annually in the United States. Prevention is suspected to be an important solution to this problem. Although OM management has no universal standard yet, it may imply watchful waiting, antibiotic treatment, adenoidectomy, insertion of tympanostomy tubes and (future) vaccination. Approximately 80% of the acute otitis media (AOM) cases is self-limiting within 2-14 days and also otitis media with effusion (OME) resolves spontaneously: 60% of newly detected OME resolves within 3 months. However, in a significant part of the OM population persistent or recurrent episodes of OM are responsible for a significant morbidity for both children and parents, despite variable treatment options. Through the set up of a new prospective cohort in a clinical setting, relevant patient characteristics, the role of bacterial and viral pathogens, the role of recurrent infection in relation to biofilm formation, and the host response at protein level will be studied in detail. This project is expected to increase the understanding of the underlying mechanisms of OM disease, which will support future treatment and prevention strategies. Better understanding in OM pathogenesis is warranted in order to develop these novel preventive strategies.

NCT ID: NCT00839254 Completed - Clinical trials for Infections, Streptococcal

Impact on Carriage, Acute Otitis Media, Immuno & Safety of GSK Biologicals' Pneumococcal Conjugate Vaccine 1024850A

Start date: February 18, 2009
Phase: Phase 3
Study type: Interventional

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. influenzae and in reducing occurrence of hospital-diagnosed pneumonia cases, tympanostomy tube placement and outpatient antimicrobial prescriptions in children starting vaccination below 18 months of age. These data will be collected from the national registers and will be analyzed in combination with data collected for subjects enrolled in a large scale cluster-randomized study 111442. The study will also assess the immune response to the GSK1024850A vaccine and the impact of the vaccine on occurrence of acute otitis media, carriage, safety in children starting vaccination below 18 months of age.

NCT ID: NCT00809601 Active, not recruiting - Clinical trials for Recurrent Acute Otitis Media

Study of Different Kinds of Ear Tubes

Start date: May 2008
Phase: N/A
Study type: Interventional

There are different kinds of ear tubes that may be inserted into the tympanic membrane to relieve recurrent acute otitis and hearing impairment due to otitis media with effusion. The tubes differ in size, shape and material. No-one knows if there are differences between the different kinds of tubes regarding complications. The investigators' hypothesis is that there is differences between the different kinds of tubes regarding complications. To test the investigators' hypothesis, the investigators are about to conduct a randomized controlled study of four kinds of tubes having two different material and two different shapes.