Acute Otitis ExternaPhase 3NCT00945802
FST-201 In The Treatment of Acute Otitis Externa
A Phase 3 study testing FST-201 (dexamethasone 0.1%) Otic Suspension and ciprofloxacin 0.3%, dexamethasone 0.1% in people with Acute Otitis Externa, run by Shire at 6 sites in United States.
Trial summary
The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Otitis Externa
- What is being tested?
- FST-201 (dexamethasone 0.1%) Otic Suspension and ciprofloxacin 0.3%, dexamethasone 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 6 sitesUnited States
- Study dates
- 31 Jul 2009to 31 Jul 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have a clinical diagnosis of AOE in one or both ears, defined as a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1).
- Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race.
- Provide written informed consent or parental assent.
- Be willing and able to follow all instructions and attend all study visits
Who cannot join
- All subjects must not:
- Have known sensitivity to any component of the study medications
- Have a current infection requiring systemic antimicrobial treatment
- Have used topical or systemic pain meds on the same day as Screening/Baseline Visit 1 and for the duration of the study.
- Take any systemic (within 30 days) or otic corticosteroids (within 1 days) prior to Screening/Baseline Visit 1
- Current use of topical or systemic non-steroidal or other anti-inflammatory drugs.
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- Use any topical otic treatment with alcohol, vinegar, hydrogen peroxide or other astringent medication during the course of the study or on the same day as Screening/Baseline Visit 1
- Have taken any antibiotics within 3 days prior to Visit 1
- Have signs and symptoms of AOE for > 4 weeks at Screening/Baseline Visit 1
- Have a non-intact or perforated tympanic membrane in the enrolled ear
- Have a clinical diagnosis of chronic suppurative otitis media, acute otitis media or acute otorrhea in patients with tympanostomy tubes
- Have a clinical diagnosis of malignant otitis externa
- Have overt fungal AOE
- Have a viral infection of the pinna or tympanic membrane (i.e herpes zoster)
- Have congenital abnormalities of the external auditory canal in the enrolled ear(s)
- Have obstructive bony exostoses in the enrolled ear(s)
- Have mastoid or other suppurative, non-infectious ear disorders (e.g, cholesteatoma)
- Have malignant tumors of the external auditory canal
- Have a history of otologic surgery. Surgery performed more than 1 year prior to Screening/Baseline Visit 1and limited to the tympanic membrane is allowed
- Have seborrheic dermatitis of the external auditory canal
- Have a current or prior history of immunosuppressive disorders
- Have acute or chronic renal insufficiency, hepatitis or diabetes mellitus
- Be pregnant, nursing or planning a pregnancy.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Austin Ear, Nose, and Throat Clinic
Austin, Texas, 78705
ENT Associates of South Florida
Boynton Beach, Florida, 33426
San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, 78215
San Antonio Ear, Nose, and Throat Research
San Antonio, Texas, 78229
Ear Institute of Texas
San Antonio, Texas, 78258
Study site
Sarasota, Florida, 34239
About this study
Official title: A Multi-Center, Randomized, Double-Masked Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex (Ciprofloxacin 0.3%, Dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, Inc.) in Subjects With Acute Otitis Externa
The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.
- Conditions
- Acute Otitis Externa
- Being tested
- FST-201 (dexamethasone 0.1%) Otic Suspension, ciprofloxacin 0.3%, dexamethasone 0.1%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FST-201 (dexamethasone 0.1%) Otic SuspensionDrug
Instill four drops two times a day
ciprofloxacin 0.3%, dexamethasone 0.1%Drug
Also called Ciprodex
Instill four drops two times a day
| Study group | Role | What they receive |
|---|---|---|
| FST-201 (dexamethasone 0.1%) Otic Suspension | Experimental | Not described Receives: Drug: FST-201 (dexamethasone 0.1%) Otic Suspension |
| ciprofloxacin 0.3%, dexamethasone 0.1% | Active comparator | Not described Receives: Drug: ciprofloxacin 0.3%, dexamethasone 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge.
Measured: 1 year
Secondary outcomes (1)
Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study start31 Jul 2009
- Primary completion31 Jul 2010
- Study completion31 Jul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Otitis ExternaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shire
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Study Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945802
- Sponsor's protocol ID
- FST201-AOE-02
- Status last verified
- May 2021
- First submitted
- 23 Jul 2009
- Last updated
- 27 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Randomized, Double-Masked Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex (Ciprofloxacin 0.3%, Dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, Inc.) in Subjects With Acute Otitis Externa
- ClinicalTrials.gov ID
- NCT00945802
- Acronym / sponsor ID
- FST201-AOE-02
- Conditions
- Acute Otitis Externa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 31 Jul 2009 (actual)
- Primary completion
- 31 Jul 2010 (actual)
- Study completion
- 31 Jul 2010 (actual)
- First posted
- 24 Jul 2009 (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 objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FST-201 (dexamethasone 0.1%) Otic Suspension | Experimental | Drug: FST-201 (dexamethasone 0.1%) Otic Suspension |
| ciprofloxacin 0.3%, dexamethasone 0.1% | Active comparator | Drug: ciprofloxacin 0.3%, dexamethasone 0.1% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have a clinical diagnosis of AOE in one or both ears, defined as a clinical score of at least 1 for edema (0-3 scale), 2 for overall inflammation (0-3 scale) and 1 for tenderness (absent=0, present=1).
- Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race.
- Provide written informed consent or parental assent.
- Be willing and able to follow all instructions and attend all study visits
Key exclusion criteria (23 listed)
- Have known sensitivity to any component of the study medications
- Have a current infection requiring systemic antimicrobial treatment
- Have used topical or systemic pain meds on the same day as Screening/Baseline Visit 1 and for the duration of the study.
- Take any systemic (within 30 days) or otic corticosteroids (within 1 days) prior to Screening/Baseline Visit 1
- Current use of topical or systemic non-steroidal or other anti-inflammatory drugs.
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 |
|---|---|---|
| FST-201 (dexamethasone 0.1%) Otic SuspensionInstill four drops two times a day | Drug | FST-201 (dexamethasone 0.1%) Otic Suspension |
| ciprofloxacin 0.3%, dexamethasone 0.1%Also: CiprodexInstill four drops two times a day | Drug | ciprofloxacin 0.3%, dexamethasone 0.1% |
Primary outcome
Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge.
Time frame: 1 year
1 secondary outcome
Microbiological resolution defined as elimination of pre-treatment pathogenic bacteria.
Time frame: 1 year
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
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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.
Study Director study director
Takeda
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FST-201 (dexamethasone 0.1%) Otic Suspension and ciprofloxacin 0.3%, dexamethasone 0.1% in people with Acute Otitis Externa, run by Shire at 6 sites 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 4 inclusion and 23 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 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
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. 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?
Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge. (time frame: 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 27 May 2021.