A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes - Full Text View

Purpose

The purpose of this study is to determine if AL-15469A / AL-38905 is safe and effective in treating middle ear infections in patients with ear tubes.

Condition	Intervention	Phase
Acute Otitis Media With Tympanostomy Tubes	Drug: AL-15469A / AL-38905	Phase III

MedlinePlus related topics:

Ear Infections

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment

Official Title:	Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)

Further study details as provided by Alcon Research:

Primary Outcome Measures:

Clinical cure rate at the test of cure visit as determined by the investigator [ Time Frame: From baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to cessation of otorrhea [ Time Frame: From baseline ] [ Designated as safety issue: Yes ]
Microbiological outcome [ Time Frame: From baseline ] [ Designated as safety issue: Yes ]
Treatment failures [ Time Frame: From baseline ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	800
Study Start Date:	December 2005
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
2: Active Comparator ofloxacin 0.3%	Drug: AL-15469A / AL-38905 Ear drops
1: Active Comparator AL-15469A/AL-38905	Drug: AL-15469A / AL-38905 Ear drops

Eligibility

Criteria

Inclusion Criteria:

6 months to 12 years old
Ear tubes in one or both ears
Ear drainage visible by the parent / guardian
Ear drainage less than 21 days
Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
Patient may not have non-tube otorrhea
Patient may not have had otic surgery other than tube placement in the last year
Patient may not be a menarchal female
Diabetic patients are not eligible
Patient may not have any disease or condition that would negatively affect the conduct of the study
Patient may not require any other systemic antimicrobial therapy during the study.
Patient must meet certain medication washouts to be eligible
Analgesic use (other than acetaminophen) is not allowed
Patient may not be pre-disposed to neurosensory hearing loss

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00578474

Locations


United States, California
	Sacramento
	Sacramento, California, United States, 95815

Sponsors and Collaborators

Alcon Research

Investigators


Study Director:	Sheryl Dupree	sheryl.dupre@alconlabs.com

More Information

Responsible Party:	Alcon ( Sheryl Dupree )
Study ID Numbers:	C-05-35
First Received:	December 19, 2007
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00578474
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Otorhinolaryngologic Diseases

Otitis

Otitis Media

Ear Diseases

ClinicalTrials.gov processed this record on October 10, 2008

Sponsored by:	Alcon Research
Information provided by:	Alcon Research
ClinicalTrials.gov Identifier:	NCT00578474