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

Otorrhea Clinical Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01111877
• Other study ID #: C-09-041
• Status: Terminated
• Phase: N/A
• First received: April 26, 2010
• Last updated: January 31, 2012
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1389
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 12 Years

Eligibility

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.

Study Design

N/A

Related Conditions & MeSH terms

• Otorrhea

Locations

Country	Name	City	State
United States	Contact Alcon Call Center for Trial Locations	Fort Worth	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of, time to, and relationship of risk factors associated with otorrhea post tympanostomy tube insertion.		Up to 1 year	No