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

NCT ID: NCT01111877

Last Updated: 2012-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

1389 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-11-30

Brief Summary

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

Detailed Description

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Conditions

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Otorrhea

Eligibility Criteria

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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.
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alcon Research

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Contact Alcon Call Center for Trial Locations

Fort Worth, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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C-09-041

Identifier Type: -

Identifier Source: org_study_id

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