Acute Otitis MediaPhase 3NCT01071902
Safety and Efficacy of Moxidex Otic
A Phase 3 study testing Moxidex otic solution, Moxifloxacin otic solution and Tympanostomy tubes in people with Acute Otitis Media, run by Alcon Research at 1 site in United States.
Trial summary
The purpose of this study is to determine if Moxidex otic solution 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, Moxifloxacin otic solution and Tympanostomy tubes
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Oct 2011
- 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 of age
- Ear tubes in one or both ears
- Ear drainage visible by parent/guardian
- Ear drainage less than 21 days
- Other protocol-defined inclusion criteria may apply
Who cannot join
- Patients not otorrhea-free for 7 or less following tympanostomy tube surgery
- Ear tube with antimicrobial activity; ear tube longer than 2.5mm
- Non-tube otorrhea
- No otic surgery other than tube placement in the last year
- No menarchial females; no diabetic patients
- No patients with any disease or condition that would negatively affect the conduct of the study
Show all 11Show fewer
- No patients taking 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
- Patients may not be predisposed to neurosensory hearing loss
- Other protocol-defined exclusion criteria may apply
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
Official title: Safety and Efficacy Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media With Otorrhea in Tympanostomy Tubes
The purpose of this study is to determine if Moxidex otic solution is safe and effective in treating middle ear infections in patients with ear tubes.
- Conditions
- Acute Otitis Media
- Being tested
- Moxidex otic solution, Moxifloxacin otic solution, Vehicle, Tympanostomy tubes
- Keywords
- ear tubes, ear drainage, ear infection, ear drops, acute otitis media
- Medical subject headings
- Otitis Media, Otitis
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
Moxifloxacin otic solutionDrug
4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
VehicleOther
4 drops into the infected ear(s) twice daily (morning and evening) for 7 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 |
| Moxifloxacin | Active comparator | Moxifloxacin otic solution Receives: Drug: Moxifloxacin otic solution; Device: Tympanostomy tubes |
| Vehicle | Placebo comparator | Vehicle Receives: Other: Vehicle; Device: Tympanostomy tubes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Cure at End of Treatment
Measured: Day 8
Secondary outcomes (2)
Time to Cessation of Otorrhea
Measured: From First Dose
Microbiological Success at End of Treatment
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionOct 2011
- Study completionOct 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 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 400 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
- NCT01071902
- Sponsor's protocol ID
- C-09-033
- Status last verified
- Nov 2012
- First submitted
- 18 Feb 2010
- 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 Evaluation of Topical Moxidex Otic Solution in the Treatment of Acute Otitis Media With Otorrhea in Tympanostomy Tubes
- ClinicalTrials.gov ID
- NCT01071902
- Acronym / sponsor ID
- C-09-033
- Conditions
- Acute Otitis Media
- Keywords
- ear tubes, ear drainage, ear infection, ear drops, acute otitis media
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Management decision
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Alcon ResearchIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 19 Feb 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.
The purpose of this study is to determine if Moxidex otic solution 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
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Moxidex | Experimental | Drug: Moxidex otic solution, Device: Tympanostomy tubesMoxidex otic solution |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin otic solution, Device: Tympanostomy tubesMoxifloxacin otic solution |
| Vehicle | Placebo comparator | Other: Vehicle, Device: Tympanostomy tubesVehicle |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 6 months to 12 years of age
- Ear tubes in one or both ears
- Ear drainage visible by parent/guardian
- Ear drainage less than 21 days
- Other protocol-defined inclusion criteria may apply
Key exclusion criteria (11 listed)
- Patients not otorrhea-free for 7 or less following tympanostomy tube surgery
- Ear tube with antimicrobial activity; ear tube longer than 2.5mm
- Non-tube otorrhea
- No otic surgery other than tube placement in the last year
- No menarchial females; no diabetic patients
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 |
| Moxifloxacin otic solution4 drops into the infected ear(s) twice daily (morning and evening) for 7 days | Drug | Moxifloxacin |
| Vehicle4 drops into the infected ear(s) twice daily (morning and evening) for 7 days | Other | Vehicle |
| Tympanostomy tubesTubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children | Device | Moxidex, Moxifloxacin, Vehicle |
Primary outcome
Clinical Cure at End of Treatment
Time frame: Day 8
2 secondary outcomes
Time to Cessation of Otorrhea
Time frame: From First Dose
Microbiological Success at End of Treatment
Time frame: Day 8
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 3 Dec 2012.
Related trials for Acute Otitis Media
Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Moxidex otic solution, Moxifloxacin otic solution and Tympanostomy tubes in people with Acute Otitis Media, 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 5 inclusion and 11 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 3 Dec 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. Some participants in this study may receive a placebo. 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 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?
Clinical Cure at End of Treatment (time frame: Day 8). 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.