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FST-201 In The Treatment of Acute Fungal Otitis Externa
This study has been terminated.
Sponsor:
Shire
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00945646
First received: July 23, 2009
Last updated: September 14, 2015
Last verified: September 2012
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Purpose
The objective of this study is to evaluate the efficacy of FST-201 compared to vehicle in the treatment of acute fungal otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute fungal otitis externa.
| Condition | Intervention | Phase |
|---|---|---|
| Acute Fungal Otitis Externa | Drug: FST-201 (dexamethasone 0.1%) Otic Suspension Drug: Vehicle | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double (Participant, Investigator) Primary Purpose: Treatment |
| Official Title: | A Multi-Center, Randomized, Double-Masked, Vehicle-Controlled Clinical Study Evaluating the Efficacy Of FST-201 (Dexamethasone 0.1%) Otic Suspension in Subjects With Acute Fungal Otitis Externa |
Resource links provided by NLM:
Further study details as provided by Shire:
Primary Outcome Measures:
- Overall clinical cure as defined by absence of the signs and symptoms of AFOE including ear inflammation, edema, tenderness, pruritis and otic discharge. [ Time Frame: 1 year ]
Secondary Outcome Measures:
- Microbiological resolution defined as absence of pre-treatment pathogenic fungal species. [ Time Frame: 1 year ]
| Enrollment: | 6 |
| Study Start Date: | July 2009 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: FST-201 (dexamethasone 0.1%) Otic Suspension |
Drug: FST-201 (dexamethasone 0.1%) Otic Suspension
Instill four drops times two times a day.
|
| Placebo Comparator: vehicle |
Drug: Vehicle
Instill four times two times a day
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have a clinical diagnosis of AFOE of in one or both ears, based on 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) and/or 1 for pruritis (absent = 0, present = 1)
- Have appearance consistent with fungal debris, i.e. white or black appearance consistent with Aspergillus spp. or Candida spp.
- Be at least 18 years of age at Visit 1 (Day 1, Screening/Baseline) of either sex and any race
- Provide written informed consent
- Be willing and able to follow all instructions and attend all study visits
- If female and of child bearing potential, agree to and submit a urine sample for pregnancy testing at Visit 1 and upon their exit from the study. Post menopausal is defined as having no menses for 12 consecutive months.
Exclusion Criteria:
- Have known sensitivity to any component of the study medications
- Have a current infection requiring systemic antimicrobial treatment
- Take any systemic (within 30 days) or otic corticosteroids (within 1 day) prior to Visit 1
- Have used topical or systemic anti-inflammatory agents on the same day as Visit 1 and for the duration of the study
- Have used topical or systemic pain medications on the same day as Visit 1 and for the duration of the study
- Have used any topical otic treatment within 1 days prior to Visit 1
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945646
Please refer to this study by its ClinicalTrials.gov identifier: NCT00945646
Locations
| United States, Florida | |
| ENT Associates of South Florida | |
| Boynton Beach, Florida, United States, 33426 | |
| Sarasota,, Florida, United States, 34239 | |
| United States, Texas | |
| Austin Ear, Nose, and Throat Clinic | |
| Austin, Texas, United States, 78705 | |
| San Antonio Ear, Nose, and Throat Research | |
| San Antonio, Texas, United States, 78215 | |
| San Antonio Ear, Nose, and Throat Research | |
| San Antonio, Texas, United States, 78229 | |
| Ear Institute of Texas | |
| San Antonio, Texas, United States, 78258 | |
Sponsors and Collaborators
Shire
More Information
| Responsible Party: | Shire |
| ClinicalTrials.gov Identifier: | NCT00945646 History of Changes |
| Other Study ID Numbers: |
FST201-AFOE-02 |
| Study First Received: | July 23, 2009 |
| Last Updated: | September 14, 2015 |
Additional relevant MeSH terms:
|
Otitis Otitis Externa Otomycosis Ear Diseases Otorhinolaryngologic Diseases Mycoses Dexamethasone acetate Dexamethasone 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 |
ClinicalTrials.gov processed this record on September 21, 2017