Acute Otitis MediaPhase 3NCT00578474
A Phase III Study of an Otic Formulation in Acute Otitis Media With Tympanostomy Tubes
A Phase 3 study testing Moxidex otic solution, Ofloxacin otic solution and Tympanostomy tubes in people with Acute Otitis Media, run by Alcon Research.
Trial summary
The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Acute Otitis Media
- What is being tested?
- Moxidex otic solution, Ofloxacin otic solution and Tympanostomy tubes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 911 participants
- Where
- No sites listed yet
- Study dates
- Dec 2005to Aug 2008
- Phase
- Phase 3
- 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
Who may be able to join
- 6 months to 12 years old
- Ear tubes in one or both ears
- Ear drainage visible by the parent / guardian
- Ear drainage less than 21 days
- Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
- Patient may not have non-tube otorrhea
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- Patient may not have had otic surgery other than tube placement in the last year
- Patient may not be a menarchal female
- Diabetic patients are not eligible
- Patient may not have any disease or condition that would negatively affect the conduct of the study
- Patient may not require any other systemic antimicrobial therapy during the study
- Patient must meet certain medication washouts to be eligible
- Analgesic use (other than acetaminophen) is not allowed
- Patient may not be pre-disposed to neurosensory hearing loss
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Age related
- Other protocol-defined exclusion criteria may apply
About this study
Official title: Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)
The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.
- Conditions
- Acute Otitis Media
- Being tested
- Moxidex otic solution, Ofloxacin otic solution, Tympanostomy tubes
- Keywords
- Acute otitis media, Tympanostomy tubes
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Moxidex otic solutionDrug
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
Ofloxacin otic solutionDrug
Also called FLOXIN
5 drops into the infected ear(s) twice daily (morning and evening) for 10 days
Tympanostomy tubesDevice
Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
| Study group | Role | What they receive |
|---|---|---|
| Moxidex | Experimental | Moxidex otic solution Receives: Drug: Moxidex otic solution; Device: Tympanostomy tubes |
| FLOXIN | Active comparator | Ofloxacin otic solution Receives: Drug: Ofloxacin otic solution; Device: Tympanostomy tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical cure rate at the test of cure visit as determined by the investigator
Measured: From baseline
Secondary outcomes (3)
Time to cessation of otorrhea
Measured: From baseline
Microbiological outcome
Measured: From baseline
Treatment failures
Measured: From baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2007 (estimated)
- Study startDec 2005
- Primary completionAug 2008
- Study completionAug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis MediaStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 911 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcon Research
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Contact Alcon Call Center, Study director, 1-888-451-3937
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00578474
- Sponsor's protocol ID
- C-05-35
- Status last verified
- Nov 2012
- First submitted
- 19 Dec 2007
- Last updated
- 3 Dec 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of a Topical Otic Formulation in the Treatment of Acute Otitis Media With Otorrhea Through Tympanostomy Tubes (AOMT)
- ClinicalTrials.gov ID
- NCT00578474
- Acronym / sponsor ID
- C-05-35
- Conditions
- Acute Otitis Media
- Keywords
- Acute otitis media, Tympanostomy tubes
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 911 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2008 (actual)
- First posted
- 21 Dec 2007 (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.
The purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Moxidex | Experimental | Drug: Moxidex otic solution, Device: Tympanostomy tubesMoxidex otic solution |
| FLOXIN | Active comparator | Drug: Ofloxacin otic solution, Device: Tympanostomy tubesOfloxacin otic solution |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (15 listed)
- 6 months to 12 years old
- Ear tubes in one or both ears
- Ear drainage visible by the parent / guardian
- Ear drainage less than 21 days
- Ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube
Key exclusion criteria (2 listed)
- Age related
- Other protocol-defined exclusion criteria may apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Moxidex otic solution4 drops into the infected ear(s) twice daily (morning and evening) for 7 days | Drug | Moxidex |
| Ofloxacin otic solutionAlso: FLOXIN5 drops into the infected ear(s) twice daily (morning and evening) for 10 days | Drug | FLOXIN |
| Tympanostomy tubesTubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children | Device | FLOXIN, Moxidex |
Primary outcome
Clinical cure rate at the test of cure visit as determined by the investigator
Time frame: From baseline
3 secondary outcomes
Time to cessation of otorrhea
Time frame: From baseline
Microbiological outcome
Time frame: From baseline
Treatment failures
Time frame: From baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 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.
Contact Alcon Call Center study director
1-888-451-3937
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moxidex otic solution, Ofloxacin otic solution and Tympanostomy tubes in people with Acute Otitis Media, run by Alcon Research.
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 15 inclusion and 2 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: finished, as of the sponsor's last update on 3 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical cure rate at the test of cure visit as determined by the investigator (time frame: From baseline). 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 3 Dec 2012.