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Natural History Study of Incidence of Otorrhea Following Tympanostomy Tube Insertion in Children 6 Months to 12 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01111877
Recruitment Status : Terminated (Management Decision)
First Posted : April 28, 2010
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):
Alcon Research

Brief Summary:
This study was conducted to describe the time to first incidence of otorrhea post tympanostomy tube insertion.

Condition or disease

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Study Type : Observational
Actual Enrollment : 1389 participants
Study Start Date : May 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : November 2011

Primary Outcome Measures :
  1. Incidence of, time to, and relationship of risk factors associated with otorrhea post tympanostomy tube insertion. [ Time Frame: Up to 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients between the ages of 6 months and 12 years who are undergoing unilateral or bilateral myringotomy with placement of tympanostomy tube.

Inclusion Criteria:

  • Participants must be at least 6 months old and no more than 13 years of age at the time of enrollment scheduled for unilateral or bilateral myringotomy and tympanostomy tube insertion. Patients and/or child must read/sign informed consent and comply with requirement of the study.

Exclusion Criteria:

  • There are no exclusion criteria.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01111877

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United States, Texas
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States, 76134
Sponsors and Collaborators
Alcon Research

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Responsible Party: Alcon Research Identifier: NCT01111877     History of Changes
Other Study ID Numbers: C-09-041
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: January 2012
Keywords provided by Alcon Research:
ear tubes
ear drainage
ear infection
ear drops
tympanostomy tubes
Pediatric patients