OtorrheaNCT01111877
Natural History Study of Incidence of Otorrhea Following Tympanostomy Tube Insertion in Children 6 Months to 12 Years
An observational study of Otorrhea, run by Alcon Research at 1 site in United States.
Trial summary
This study was conducted to describe the time to first incidence of otorrhea post tympanostomy tube insertion. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Otorrhea
- How many people
- 1,389 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Nov 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- There are no exclusion criteria.
Trial locations and contacts
1 site in 1 country.
United States1 site
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, 76134
About this study
This study was conducted to describe the time to first incidence of otorrhea post tympanostomy tube insertion.
- Conditions
- Otorrhea
- Keywords
- ear tubes, ear drainage, ear infection, ear drops, tympanostomy tubes, Pediatric patients
- Medical subject headings
- Otitis
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of, time to, and relationship of risk factors associated with otorrhea post tympanostomy tube insertion.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Management Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OtorrheaStudies of the same condition, open and under way.
- More trials run by Alcon ResearchThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 1,389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01111877
- Sponsor's protocol ID
- C-09-041
- Status last verified
- Jan 2012
- First submitted
- 26 Apr 2010
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural History Study of Incidence of Otorrhea Following Tympanostomy Tube Insertion in Children 6 Months to 12 Years
- ClinicalTrials.gov ID
- NCT01111877
- Acronym / sponsor ID
- C-09-041
- Conditions
- Otorrhea
- Keywords
- ear tubes, ear drainage, ear infection, ear drops, tympanostomy tubes, Pediatric patients
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Management Decision
- Enrolment
- 1,389 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 28 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted to describe the time to first incidence of otorrhea post tympanostomy tube insertion.
Study design
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- There are no exclusion criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of, time to, and relationship of risk factors associated with otorrhea post tympanostomy tube insertion.
Time frame: Up to 1 year
Results and safety
The study was stopped early (reason given: Management Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otorrhea, run by Alcon Research at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Management Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of, time to, and relationship of risk factors associated with otorrhea post tympanostomy tube insertion. (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.