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Otitis clinical trials

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NCT ID: NCT01447017 Completed - Clinical trials for Acute Otitis Externa

A Study of DPK-060 to Investigate Clinical Safety and Efficacy in Patients With Acute External Otitis

Start date: November 2011
Phase: Phase 2
Study type: Interventional

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. The secondary objectives are to evaluate clinical cure and microbiological growth following treatment with DPK-060 2% ear drops compared to placebo for DPK-060 ear drops.

NCT ID: NCT01443416 Completed - Clinical trials for Invasive Streptococcus Pneumoniae Disease

An Alternative Booster Vaccine Against Meningitis and Ear Infections

Start date: April 2012
Phase: Phase 3
Study type: Interventional

This is a study to evaluate an alternative booster for pneumococcal conjugate vaccination (PCV) for children at 12 months of age. Currently in the UK, 3 doses of a vaccine called Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein called CRM197, are given to children at 2, 4 and 12 months of age. There is some evidence that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used vaccine when used as an alternative vaccine at 12 months of age. Although PHiD-CV contains only 10 serotypes, there is evidence that it generates cross-reactive antibodies against two of the three additional serotypes included in PCV-13 which might be enough to protect children against disease caused by these two serotypes. Furthermore, previous studies have shown that PHiD-CV confers protection against a common otitis media pathogen in children called nontypeable H. influenzae (NTHi) by attachment to a carrier protein called Protein D, which is derived from NTHi. In addition, the use of a carrier protein, which is not closely related to an antigen included in any coadministered or previously administered routine vaccine minimises the risk of interference related to it. The investigators aim to recruit 168 healthy children at the age of 12 months who have already received two doses of PCV-13 according to the UK routine immunisation schedule at 2 and 4 months of age. Participants will then be randomised to receive a booster dose of either PCV-13 or PHiD-CV at 12 months of age. Three visits will take place at their parents' home and will involve a blood test followed by a dose of PCV-13 or PHiD-CV on visit 1, and a blood test on each of the visits 2 (1 month after visit 1) and 3 (1 year after visit 1).

NCT ID: NCT01406275 Completed - Otitis Maedia Clinical Trials

Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media)

Start date: January 2008
Phase: N/A
Study type: Observational

This post-marketing surveillance study of CLAVAMOX® was designed to collect and assess the information on proper use, such as safety and efficacy, under actual use conditions, targeting pediatric Japanese patients with diseases (superficial skin infection, deep skin infection, lymphangitis, lymphadenitis, chronic pyoderma, pharyngitis, laryngitis, tonsillitis, acute bronchitis, cystitis, pyelonephritis) other than otitis media. ("CLAVAMOX" is a trademark of the GlaxoSmithKline group of companies.)

NCT ID: NCT01404611 Completed - Acute Otitis Media Clinical Trials

Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating middle ear infections in children with ear tubes.

NCT ID: NCT01395966 Completed - Acute Otitis Media Clinical Trials

Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

Start date: June 2011
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and effective in treating middle ear infections in children with ear tubes.

NCT ID: NCT01359098 Completed - Clinical trials for Otorhinolaryngologic Diseases

Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa

Ciprodexa Foam
Start date: July 2011
Phase: Phase 2
Study type: Interventional

The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7 days.

NCT ID: NCT01339546 Completed - Trauma Clinical Trials

National Trends in Otitis Media in Children Under 5 Years of Age

Start date: June 9, 2010
Phase:
Study type: Observational

The rationale for this study is to assess the change in ambulatory care visit rates for acute otitis media between the period before (2001-2009) and after the introduction of the 13-valent pneumococcal conjugate vaccine (13vPnC) (2011-2013) among children less than 5 years old in the United States.

NCT ID: NCT01272999 Completed - Acute Otitis Media Clinical Trials

Impact of Prevnar 13 on Ear Infections in Children

Start date: May 21, 2010
Phase:
Study type: Observational

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. It is expected that the effectiveness of Prevnar 13 against ear infections in children will be similar to that observed following Prevnar. Pfizer has committed to conduct a postmarketing study of the impact of Prevnar 13 in reducing ear infections among children.

NCT ID: NCT01263210 Completed - Clinical trials for Recurrent Acute Otitis Media

Pneumococcal Vaccination of Otitis-prone Children

Start date: March 2003
Phase: N/A
Study type: Interventional

Acute otitis media (AOM) is a common childhood disease, which becomes recurrent in 15-20% of the cases. Streptococcus pneumoniae is one of the leading causative agents, and a small reduction in the number of AOM episodes has been noted in unselected child cohorts after vaccination with conjugate heptavalent pneumococcal vaccine. This study was performed in order to investigate whether vaccination could reduce the number of AOM episodes in very young, otitis-prone children.

NCT ID: NCT01251432 Completed - Clinical trials for Eustachian Tube Dysfunction

Risk Factors and Potential Causes of Eustachian Tube Dysfunction in Adults

Start date: June 2010
Phase: N/A
Study type: Observational

This research study measures how well the Eustachian tube works and looks directly at the anatomy of the Eustachian tube in adults who have had tympanostomy tubes surgically inserted into their eardrums because they have been diagnosed as having either "otitis media" or "poor Eustachian tube function". The Eustachian tube is a biologic tube that connects the back of the nose to the middle ear (the airspace located behind your eardrum). That tube is usually closed, but can be opened by swallowing and other activities. Periodic openings of the Eustachian tube allow air to flow between the nose and middle ear which keeps the pressure of gas in the middle ear at the same level as that of the atmosphere, a condition required for good hearing. In children and adults, middle-ear diseases such as otitis media with effusion (the buildup of fluid within the middle ear) and a form of temporary hearing loss (conductive hearing loss) occur if the Eustachian tube does not open, does not open frequently enough or is always open (called a patulous Eustachian tube). A diagnosis of these different conditions can be made using standard, clinical tests of Eustachian tube function and the Eustachian tube can be visualized where it enters the back of the nose using a specialized telescope called an endoscope. Some scientific reports suggest that the cause of poor Eustachian tube function in an individual can be determined by studying the anatomy of the Eustachian tube at the back of the nose and the movements of the Eustachian tube in that area during swallowing, talking and other activities using an endoscope. In this study, the investigators plan to explore the relationship between the results of the standard Eustachian tube function tests and those for the anatomy and function of the Eustachian tube in adults with a disease condition likely to be caused by poor Eustachian tube function. Also, there are a number other disease conditions (examples: nasal allergy, acid reflux disease) that are related to poor Eustachian tube function and it is possible that these conditions and their effect on Eustachian tube function can be treated with medicines. Therefore, the investigators also plan to evaluate enrolled persons for those conditions. It is expected that if the results of the standard Eustachian tube function tests can be explained by the anatomy of the back of the nose and Eustachian tube, the functional anatomy (movements during swallowing etc) of the Eustachian tube or the presence of allergy and or/acid reflux disease, new medical and/or surgical treatments can be developed to improve Eustachian tube function and "cure" or treat the associated middle-ear diseases.