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Otitis clinical trials

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NCT ID: NCT00796224 Completed - Acute Otitis Media Clinical Trials

Pharmacokinetics Of Azithromycin Immediate Release And Extended Release Formulation In Kids With Acute Otitis Media

Start date: December 2008
Phase: Phase 2
Study type: Interventional

The purpose of this study was to determine the pharmacokinetics (PK), safety and clinical response following a single dose of either 30 mg/kg IR (Immediate Release) or 60 mg/kg ER (Extended Release) formulation in pediatric subjects 6 months to 6 years of age inclusive.

NCT ID: NCT00781521 Completed - Otitis Media Clinical Trials

Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children

Start date: November 2002
Phase: Phase 3
Study type: Interventional

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. The currently approved regimen is twice daily for 10 days.

NCT ID: NCT00768534 Completed - Otitis Media Clinical Trials

Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media

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

Describe the patient population and bacterial microbiology of pediatric patients presenting with spontaneous draining acute otitis media

NCT ID: NCT00765635 Completed - Hearing Loss Clinical Trials

Chlorobutanol, Potassium Carbonate, and Irrigation in Cerumen Removal

Start date: September 2008
Phase: Phase 4
Study type: Interventional

Accumulation of cerumen in the external ear canal is a common problem. The presence of cerumen not only interferes with the clinician's view of the tympanic membrane, but may also result in hearing loss and vertigo, and may predispose to ear infections. Removal of cerumen is facilitated by the use of a variety of ceruminolytics, or wax solvents. The current study was designed to evaluate the ceruminolytic effects of a single, brief application of the two most frequently used products in the investigators area, containing chlorobutanol or potassium carbonate with or without irrigation in the primary care setting in a randomized, single-blind trial. To our knowledge, this is the first randomized study comparing ceruminolytics with chlorobutanol versus potassium carbonate.

NCT ID: NCT00750633 Completed - Clinical trials for Acute Otitis Externa

A Phase III Study of an Otic Formulation in Acute Otitis Externa

Start date: June 2008
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if an otic formulation is safe and effective for the treatment of acute otitis externa (AOE).

NCT ID: NCT00736112 Withdrawn - Clinical trials for Food Hypersensitivity

Food Allergy - Tubes - Adenoids (FATA) Trial

FATA
Start date: October 2008
Phase: N/A
Study type: Interventional

The questioned proposed by this study is one of treatment: "To what extent does simultaneous BMT (Bilateral Myringotomy with Tympanostomy Tubes), adenoidectomy, and diagnosis/avoidance of food allergy affect the frequency of recurrent otitis media (ROM) versus the standard academy approach (tube insertions only) to chronic otitis media with effusion; furthermore, are adenoids a factor in OME or is food allergy diagnosis and treatment able to significantly prevent ROM after the tubes fall out?" The trial seeks to provide evidence that the treatment for Chronic OME in children should involve surgical procedures (BMT +/- adenoidectomy), as well, as a food allergy work-up and subsequent avoidance of the offending foods in order to significantly decrease ROM. To answer this question, a prospective, randomized controlled trial needs to be conducted. Since a majority of OME patients are from the pediatric population, parental consent must be obtained. Subjects in our study will initially present to the clinic with otitis media symptoms and diagnostic tests such as a tympanogram, otoscopy, and history of recurrent otitis media will be obtained. Once the surgical decision for bilateral myringotomy and tympanostomy tubes has been made, parents will be informed about the trial. The standard protocol for children presenting with initial Chronic OME is to perform a BMT. Therefore, data from the control group (Group 1) will be obtained from faculty ENT who follow the academy's recommendations. Data from Group 2 and 3 will be collected from other ENT faculty members, including the faculty co-investigator who will perform the BMT and obtain a food allergy blood draw at the time of surgery. The study's faculty co-investigator will describe food avoidance techniques to post-op patients from Groups 2 and 3. Patients with previous adenotonsillar surgery or placement of tympanostomy tubes will not be enrolled in the study. The incidence of ROM episodes in all trial groups will be recorded.

NCT ID: NCT00694486 Completed - Otitis Clinical Trials

Eustachian Tube Testing in a Pressure Chamber -- Validation Study

Start date: January 2008
Phase:
Study type: Observational

This study will compare Eustachian tube function (ETF) testing in adults with intact tympanic membranes (TM) using a pressure chamber to that obtained using standard methods requiring a non-intact TM.

NCT ID: NCT00689468 Completed - Otitis Media Clinical Trials

Echinacea Purpurea and Osteopathy in Children With Recurrent Otitis Media

Start date: July 1999
Phase: N/A
Study type: Interventional

This study was designed to evaluate the efficacy of the herb Echinacea purpurea and of cranial osteopathic manipulative treatment to prevent otitis media (middle ear infections) in young children.

NCT ID: NCT00654329 Completed - Otitis Clinical Trials

Dexmedetomidine vs Fentanyl for BMT

DexBMT
Start date: August 2005
Phase: Phase 4
Study type: Interventional

A randomized controlled clinical trial to examine effects of intranasal dexmedetomidine, an α2-adrenorecptor agonist, on pain control and agitation in children undergoing BMT.

NCT ID: NCT00645203 Completed - Acute Otitis Media Clinical Trials

Safety and Efficacy Study of Cefdinir Oral Suspension, in Pediatric Subjects to Treat Acute Otitis Media

Start date: July 2002
Phase: Phase 2/Phase 3
Study type: Interventional

To evaluate the safety and efficacy of cefdinir oral suspension in children between 6 months and 4 years of age, with acute otitis media, who are at risk of persistent or recurrent otitis media.