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Therapeutic Areas: Pediatrics/Neonatology | Otolaryngology (Ear, Nose, Throat) | Family Medicine
Disease Category: Ear Infections (Pediatric)
Location: United States, AR

Clinical Trial Details


Research Study Summary

Ear Infections (Pediatric)


The purpose of this research study is to compare the effectiveness and potential side effects of the experimental drug called ciprofloxacin plus fluocinolone acetonide otic solution, or “Cetraxal Plus,” against the active ingredients alone (ciprofloxacin and fluocinolone acetonide) in treating ear infections.

Patient Inclusion Criteria:

  • Patient of either sex between 6 months and 12 years of age (both inclusive)
  • Patients with patent tympanostomy tube in the ear which will be treated (must be present and open)
  • Patients suffering from otorrhea for 3 weeks or less
  • Signed informed consent from the patient’s legally authorized representative; also, if the patient is capable of providing assent, signed assent from the patient.

Patient Exclusion Criteria:

  • Tympanostomy tube placement 3 days or less before study entry
  • Tympanostomy tubes containing antiseptic or antibacterial activity (silver oxide or silver salts), T-type tubes
  • Acute otitis externa or malignant otitis externa
  • Otologic surgery within the previous year (other than tympanostomy tube placement)
  • Acute or chronic renal disease, active hepatitis
  • Chronic nasal obstruction and/or persistent rhinorrhea
  • Craniofacial anomalies
  • Patient predisposed to neurosensory hearing loss*
  • Use of topical or otic steroids within 3 days of enrollment or systemic steroids within 7 days of enrollment
  • Use of intranasal or inhaled steroids within 3 days of enrollment

To Learn more



Both Male and Female


6 to 12 Years

Overall Status


Facility Type



Paul Koros, RN, Site Manager
NEA Baptist Clinic - Clinical Research Center
416 E. Washington, Suite C
Jonesboro, AR 72401
Phone: 870-934-1006
Fax: 870-934-1008

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Research Center Information: NEA Baptist Clinic - Clinical Research Center

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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CW ID: 181032

Date Last Changed: July 19, 2013

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