ClinicalTrials.gg
Sign In
CompletedNCT00961675Updated Jun 14, 2021

FST-201 in the Treatment of Acute Otitis Externa

A Phase 3 interventional study of FST201 (dexamethasone 0.1% with povidone-iodine 1%) and Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% ) in Acute Otitis Externa, sponsored by Shire. Completed at 1 site in American Samoa. Open to male participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-06-14.

Sponsored by Shire (part of Takeda) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Acute Otitis Externa

Browse trials for

Keywords

  • otitis
  • acute
  • externa
  • ear
03

In context

Otitis

247 studies on the registry are indexed under Otitis; 21 are open to participants now.

This study's enrollment of 70 is below the median of 126 across 174 interventional studies indexed under Otitis.

Browse Otitis studies →

Lead sponsor

Shire is the lead sponsor of 351 studies on the registry; 2 are open to participants now.

Of its 48 completed or terminated interventional studies of FDA-regulated products, 48 (100%) have results posted.

First submitted before Shire became part of Takeda.

Browse Shire studies →All Takeda studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
  • 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
70 participants (actual)

Study arms

  • Active comparator
    FST201

    Drug: FST201 (dexamethasone 0.1% with povidone-iodine 1%)

  • Active comparator
    Ciprodex

    Drug: Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )

Interventions

  • DrugFST201 (dexamethasone 0.1% with povidone-iodine 1%)

    Drug page: FST201

    4 gtt BID (twice a day)

  • DrugCiprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )

    4 gtt BID (twice a day)

    Also known as: CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Microbiological resolution defined as elimination of pre-treatment pathogenic organism.

    Time frame: 18 days

07

Study locations

1 site
  • LBJ Tropical Medical Center, Department of Otolaryngology
    Pago Pago, 96799, American Samoa
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2009 to primary completion in Jun 2010, 9 months.

Of 12 phase 3 interventional studies under Otitis, half reached primary completion within 12 months of starting (the median); a quarter within 6 and three quarters within 15. This study's 9 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 18, 2009
First posted
Aug 19, 2009
StartActual
Aug 31, 2009
Primary completionActual
Jun 30, 2010
CompletionActual
Jun 30, 2010
Results delay requested
Sep 5, 2012
Last update
Jun 14, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 14, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00961675
Lead sponsor
Shire
Responsible party
Sponsor
First posted
Aug 19, 2009
Start date
Aug 31, 2009
Primary completion
Jun 30, 2010
Completion
Jun 30, 2010
Last update
Jun 14, 2021

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drug tested here: FST201

Other studies in this condition

Otitis →

Other studies from this sponsor

Shire →

Start the discussion