Acute Otitis ExternaPhase 3NCT00961675
FST-201 in the Treatment of Acute Otitis Externa
A Phase 3 study testing FST201 (dexamethasone 0.1% with povidone-iodine 1%) and Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% ) in people with Acute Otitis Externa, run by Shire at 1 site in American Samoa.
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 study will be conducted at one site, the Lyndon B. Johnson (LBJ) Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Acute Otitis Externa
- What is being tested?
- FST201 (dexamethasone 0.1% with povidone-iodine 1%) and Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteAmerican Samoa
- Study dates
- 31 Aug 2009to 30 Jun 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 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Study participants must:
- 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
Who cannot join
- Study participants 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
Show all 20Show fewer
- 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 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
- Be pregnant, nursing or planning a pregnancy
Trial locations and contacts
1 site in 1 country.
American Samoa1 site
LBJ Tropical Medical Center, Department of Otolaryngology
Pago Pago, 96799
About this study
Official title: A Phase III Clinical Study Evaluating the Efficacy Of FST-201 Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex 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 study will be conducted at one site, the Lyndon B. Johnson (LBJ) Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.
Read the detailed description
The proposed clinical trial will evaluate the efficacy of FST-201 (dexamethasone 0.1% with povidone-iodine 1% ) Otic Suspension vs. the FDA-approved drug Ciprodex (ciprofloxacin 0.3%, dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, Inc.) in the treatment of acute otitis externa. Acute otitis externa is a common inflammatory condition of the external auditory canal often associated with infection, allergy and dermatitis. The active ingredient in our novel dexamethasone suspension is identical in concentration and route of administration to the steroid component of the approved drug Ciprodex, which is currently the most widely-prescribed dexamethasone-containing agent in the treatment of acute otitis externa. We will enroll 60 patients (30 each in two separate treatment groups) in this trial. All patients electing to participate in this study will receive either FST-201 or Ciprodex. FST-201 and Ciprodex will be masked and provided free of charge to all study participants. Patients will be followed for at least 15 days or until their ear inflammation is either resolved or determined to need additional interventions. The study will be conducted with attention to all relevant Good Clinical Practice (GCP), International Conference on Harmonization (ICH), FDA, Health Insurance Portability and Accountability Act (HIPPA) and Declaration of Helsinki guidelines.
- Conditions
- Acute Otitis Externa
- Being tested
- FST201 (dexamethasone 0.1% with povidone-iodine 1%), Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )
- Keywords
- otitis, acute, externa, ear
- Medical subject headings
- Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FST201 (dexamethasone 0.1% with povidone-iodine 1%)Drug
4 gtt BID (twice a day)
Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )Drug
Also called CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension
4 gtt BID (twice a day)
| Study group | Role | What they receive |
|---|---|---|
| FST201 | Active comparator | Not described Receives: Drug: FST201 (dexamethasone 0.1% with povidone-iodine 1%) |
| Ciprodex | Active comparator | Not described Receives: Drug: Ciprodex (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 Acute Otitis Externa (AOE) including ear inflammation, edema, tenderness and otic discharge.
Measured: 18 days
Secondary outcomes (1)
Microbiological resolution defined as elimination of pre-treatment pathogenic organism.
Measured: 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study start31 Aug 2009
- Primary completion30 Jun 2010
- Study completion30 Jun 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 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
- NCT00961675
- Sponsor's protocol ID
- FST201-AOE-AS
- Status last verified
- Jun 2021
- First submitted
- 18 Aug 2009
- Last updated
- 14 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Clinical Study Evaluating the Efficacy Of FST-201 Otic Suspension (Foresight Biotherapeutics, Inc.) Vs. Ciprodex Otic Suspension (Alcon Laboratories, Inc.) in Subjects With Acute Otitis Externa
- ClinicalTrials.gov ID
- NCT00961675
- Acronym / sponsor ID
- FST201-AOE-AS
- Conditions
- Acute Otitis Externa
- Keywords
- otitis, acute, externa, ear
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- ShireIndustry (pharma, biotech, devices)
- Study start
- 31 Aug 2009 (actual)
- Primary completion
- 30 Jun 2010 (actual)
- Study completion
- 30 Jun 2010 (actual)
- First posted
- 19 Aug 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 study will be conducted at one site, the Lyndon B. Johnson (LBJ) Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.
Detailed description
The proposed clinical trial will evaluate the efficacy of FST-201 (dexamethasone 0.1% with povidone-iodine 1% ) Otic Suspension vs. the FDA-approved drug Ciprodex (ciprofloxacin 0.3%, dexamethasone 0.1%) Otic Suspension (Alcon Laboratories, Inc.) in the treatment of acute otitis externa. Acute otitis externa is a common inflammatory condition of the external auditory canal often associated with infection, allergy and dermatitis. The active ingredient in our novel dexamethasone suspension is identical in concentration and route of administration to the steroid component of the approved drug Ciprodex, which is currently the most widely-prescribed dexamethasone-containing agent in the treatment of acute otitis externa. We will enroll 60 patients (30 each in two separate treatment groups) in this trial. All patients electing to participate in this study will receive either FST-201 or Ciprodex. FST-201 and Ciprodex will be masked and provided free of charge to all study participants. Patients will be followed for at least 15 days or until their ear inflammation is either resolved or determined to need additional interventions. The study will be conducted with attention to all relevant Good Clinical Practice (GCP), International Conference on Harmonization (ICH), FDA, Health Insurance Portability and Accountability Act (HIPPA) and Declaration of Helsinki guidelines.
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 |
|---|---|---|
| FST201 | Active comparator | Drug: FST201 (dexamethasone 0.1% with povidone-iodine 1%) |
| Ciprodex | Active comparator | Drug: Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% ) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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
Key exclusion criteria (20 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 |
|---|---|---|
| FST201 (dexamethasone 0.1% with povidone-iodine 1%)4 gtt BID (twice a day) | Drug | FST201 |
| Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )Also: CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension4 gtt BID (twice a day) | Drug | Ciprodex |
Primary outcome
Overall clinical cure as defined by absence of the signs and symptoms of Acute Otitis Externa (AOE) including ear inflammation, edema, tenderness and otic discharge.
Time frame: 18 days
1 secondary outcome
Microbiological resolution defined as elimination of pre-treatment pathogenic organism.
Time frame: 18 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 14 Jun 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
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 FST201 (dexamethasone 0.1% with povidone-iodine 1%) and Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% ) in people with Acute Otitis Externa, run by Shire at 1 site in American Samoa.
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 3 inclusion and 20 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 14 Jun 2021. 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 American Samoa. 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 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?
Overall clinical cure as defined by absence of the signs and symptoms of Acute Otitis Externa (AOE) including ear inflammation, edema, tenderness and otic discharge. (time frame: 18 days). 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 14 Jun 2021.