FST-201 in the Treatment of Acute Otitis Externa - Full Text View

Sponsor:	Foresight Biotherapeutics
Information provided by:	Foresight Biotherapeutics
ClinicalTrials.gov Identifier:	NCT00961675

Purpose

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 LBJ Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.

Condition	Intervention	Phase
Acute Otitis Externa	Drug: FST201 (dexamethasone 0.1% with povidone-iodine 1%) Drug: Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Dexamethasone Povidone-iodine Dexamethasone acetate Doxiproct plus Ciprofloxacin Ciprofloxacin hydrochloride Cadexomer iodine Ciprofloxacin lactate Dexamethasone Sodium Phosphate Iodine Povidone

U.S. FDA Resources

Further study details as provided by Foresight Biotherapeutics:

Primary Outcome Measures:

Overall clinical cure as defined by absence of the signs and symptoms of AOE including ear inflammation, edema, tenderness and otic discharge. [ Time Frame: 18 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Microbiological resolution defined as elimination of pre-treatment pathogenic organism. [ Time Frame: 18 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	August 2009
Study Completion Date:	June 2010
Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Intervention Details:

4gtt BID

4 gtt BID

Other Name: CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension

Detailed Description:

The proposed clinical trial will evaluate the efficacy of FST-201 (dexamethasone 0.1% ) 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 GCP, ICH, FDA, HIPPA and Declaration of Helsinki guidelines.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961675

Locations

American Samoa
LBJ Tropical Medical Center, Department of Otolaryngology
Pago Pago, American Samoa, 96799

Sponsors and Collaborators

Foresight Biotherapeutics

Investigators

Principal Investigator:

Richard Wagner, MD

Global ENT Outreach

More Information

No publications provided

Responsible Party:	Richard Wagner,MD, Global ENT Outreach
ClinicalTrials.gov Identifier:	NCT00961675 History of Changes
Other Study ID Numbers:	FST201-AOE-AS
Study First Received:	August 18, 2009
Last Updated:	October 13, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Foresight Biotherapeutics:

otitis
acute
externa
ear

Additional relevant MeSH terms:

Otitis Externa
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Povidone
Ciprofloxacin
Povidone-Iodine
BB 1101
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
Plasma Substitutes
Blood Substitutes
Hematologic Agents
Therapeutic Uses

Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Infective Agents
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on February 09, 2012