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Safety and Efficacy of Moxidex Otic

This study has been terminated.
(Management decision)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01071902
First received: February 18, 2010
Last updated: November 29, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to determine if Moxidex otic solution is safe and effective in treating middle ear infections in patients with ear tubes.


Condition Intervention Phase
Acute Otitis Media
 Drug: Moxidex otic solution
Drug: Moxifloxacin otic solution
Other: Vehicle
Device: Tympanostomy tubes
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media With Otorrhea in Tympanostomy Tubes

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Clinical Cure at End of Treatment [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Cessation of Otorrhea [ Time Frame: From First Dose ] [ Designated as safety issue: No ]
  • Microbiological Success at End of Treatment [ Time Frame: Day 8 ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: February 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Moxidex
Moxidex otic solution
 Drug: Moxidex otic solution
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Device: Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Active Comparator: Moxifloxacin
Moxifloxacin otic solution
 Drug: Moxifloxacin otic solution
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Device: Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
Placebo Comparator: Vehicle
Vehicle
 Other: Vehicle
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Device: Tympanostomy tubes
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children

  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 months to 12 years of age
  • Ear tubes in one or both ears
  • Ear drainage visible by parent/guardian
  • Ear drainage less than 21 days
  • Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

  • Patients not otorrhea-free for 7 or less following tympanostomy tube surgery
  • Ear tube with antimicrobial activity; ear tube longer than 2.5mm
  • Non-tube otorrhea
  • No otic surgery other than tube placement in the last year
  • No menarchial females; no diabetic patients
  • No patients with any disease or condition that would negatively affect the conduct of the study
  • No patients taking 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
  • Patients may not be predisposed to neurosensory hearing loss
  • Other protocol-defined exclusion criteria may apply
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071902

Locations
United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research
Investigators
Study Director: Contact Alcon Call Center 1-888-451-3937
  More Information

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01071902     History of Changes
Other Study ID Numbers: C-09-033
Study First Received: February 18, 2010
Last Updated: November 29, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
ear tubes
ear drainage
ear infection
ear drops
acute otitis media

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013