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

This study has been terminated.
(Management Decision)
Sponsor:
Information provided by (Responsible Party):
Alcon Research
ClinicalTrials.gov Identifier:
NCT01111877
First received: April 26, 2010
Last updated: January 31, 2012
Last verified: January 2012
  Purpose

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


Condition
Otorrhea

Study Type: Observational

Further study details as provided by Alcon Research:

Primary Outcome Measures:
  • Incidence of, time to, and relationship of risk factors associated with otorrhea post tympanostomy tube insertion. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

Enrollment: 1389
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01111877

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

No publications provided

Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT01111877     History of Changes
Other Study ID Numbers: C-09-041
Study First Received: April 26, 2010
Last Updated: January 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Alcon Research:
ear tubes
ear drainage
ear infection
ear drops
tympanostomy tubes
Pediatric patients

ClinicalTrials.gov processed this record on September 11, 2014