Otitis MediaPhase 3NCT00781521
Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children
A Phase 3 study testing ofloxacin otic solution 0.3% in people with Otitis Media, run by Daiichi Sankyo.
Trial summary
This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. The currently approved regimen is twice daily for 10 days. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- ofloxacin otic solution 0.3%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Apr 2003
- 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
- Male or female
- 6 months of age to <12 years of age
- weight = or >4.5 kg
- Patent tympanostomy tube(s) in the affected ear(s)
- Purulent or mucopurulent otorrhea of recent onset of presumed bacterial origin
Who cannot join
- Non-bacterial otic infection
- Known or suspected hypersensitivity to ofloxacin
- Cystic fibrosis
- HIV infection
- Neutropenia
- Receiving immunosuppressive therapy
About this study
Official title: A Pilot, Multicenter, Open Label, Non Comparative Study of the Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media Twice Daily for Seven Days in Children With Tympanostomy Tubes
This was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. The currently approved regimen is twice daily for 10 days.
- Conditions
- Otitis Media
- Being tested
- ofloxacin otic solution 0.3%
- Medical subject headings
- Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ofloxacin otic solution 0.3%Drug
ofloxacin otic solution 0.3% instilled twice a day for seven days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Floxin otic solution twice a day for 7 days Receives: Drug: ofloxacin otic solution 0.3% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sponsor determined clinical cure of otitis media
Measured: 7 days
Sponsor determined microbiological cure of otitis media
Measured: 7 days
Secondary outcomes (4)
Investigator determined clinical cure
Measured: 7 days
Overall per-subject microbiological outcome
Measured: 7 days
Overall per pathogen microbiological outcome
Measured: 7 days
sign and symptoms of otitis media
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startNov 2002
- Primary completionApr 2003
- Study completionApr 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781521
- Sponsor's protocol ID
- 8280A-PRT021
- Status last verified
- Oct 2008
- First submitted
- 28 Oct 2008
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Multicenter, Open Label, Non Comparative Study of the Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media Twice Daily for Seven Days in Children With Tympanostomy Tubes
- ClinicalTrials.gov ID
- NCT00781521
- Acronym / sponsor ID
- 8280A-PRT021
- Conditions
- Otitis Media
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Primary completion
- Apr 2003 (actual)
- Study completion
- Apr 2003 (actual)
- First posted
- 29 Oct 2008 (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 was a pilot study to determine the safety and effectiveness of a twice daily, seven-day dosing regimen in acute, pediatric, otitis media in children with tympanostomy tubes. The currently approved regimen is twice daily for 10 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ofloxacin otic solution 0.3%Floxin otic solution twice a day for 7 days |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Male or female
- 6 months of age to <12 years of age
- weight = or >4.5 kg
- Patent tympanostomy tube(s) in the affected ear(s)
- Purulent or mucopurulent otorrhea of recent onset of presumed bacterial origin
Key exclusion criteria (6 listed)
- Non-bacterial otic infection
- Known or suspected hypersensitivity to ofloxacin
- Cystic fibrosis
- HIV infection
- Neutropenia
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 |
|---|---|---|
| ofloxacin otic solution 0.3%ofloxacin otic solution 0.3% instilled twice a day for seven days | Drug | 1 |
Primary outcome
Sponsor determined clinical cure of otitis media
Time frame: 7 days
Sponsor determined microbiological cure of otitis media
Time frame: 7 days
4 secondary outcomes
Investigator determined clinical cure
Time frame: 7 days
Overall per-subject microbiological outcome
Time frame: 7 days
Overall per pathogen microbiological outcome
Time frame: 7 days
sign and symptoms of otitis media
Time frame: 7 days
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 29 Oct 2008.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ofloxacin otic solution 0.3% in people with Otitis Media, run by Daiichi Sankyo.
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 6 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 29 Oct 2008. 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?
Sponsor determined clinical cure of otitis media (time frame: 7 days). The study lists 2 primary outcomes in all. 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 29 Oct 2008; AzTrials last refreshed its copy on 7 Nov 2026.