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Trial record 44 of 433 for:    OTITIS

FST-201 in the Treatment of Acute Otitis Externa

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ClinicalTrials.gov Identifier: NCT00961675
Recruitment Status : Completed
First Posted : August 19, 2009
Last Update Posted : September 30, 2015
Sponsor:
Information provided by (Responsible Party):
Shire

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

Condition or disease Intervention/treatment Phase
Acute Otitis Externa Drug: FST201 (dexamethasone 0.1% with povidone-iodine 1%) Drug: Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% ) Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: FST201 Drug: FST201 (dexamethasone 0.1% with povidone-iodine 1%)
4gtt BID

Active Comparator: Ciprodex Drug: Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% )
4 gtt BID
Other Name: CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Microbiological resolution defined as elimination of pre-treatment pathogenic organism. [ Time Frame: 18 days ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961675


Locations
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American Samoa
LBJ Tropical Medical Center, Department of Otolaryngology
Pago Pago, American Samoa, 96799
Sponsors and Collaborators
Shire
Investigators
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Principal Investigator: Richard Wagner, MD Global ENT Outreach

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00961675     History of Changes
Other Study ID Numbers: FST201-AOE-AS
First Posted: August 19, 2009    Key Record Dates
Last Update Posted: September 30, 2015
Last Verified: September 2012
Keywords provided by Shire:
otitis
acute
externa
ear
Additional relevant MeSH terms:
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Otitis
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
Ciprofloxacin
Povidone-Iodine
Dexamethasone
Dexamethasone acetate
Povidone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors