FST-201 in the Treatment of Acute Otitis Externa

NCT00961675 | Completed Phase 3

• 1 other identifier: FST201-AOE-AS
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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 Lyndon B. Johnson (LBJ) Tropical Medical Center, Department of Otolaryngology, in Pago Pago, American Samoa.

Conditions

Acute Otitis Externa

Keywords

otitis; acute; externa; ear

Outcome Measures

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.

  18 days

Secondary Outcomes (1)

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

  18 days

Study Arms (2)

FST201

ACTIVE COMPARATOR

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

Ciprodex

ACTIVE COMPARATOR

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

Interventions

FST201 (dexamethasone 0.1% with povidone-iodine 1%) DRUG

4 gtt BID (twice a day)

FST201

Ciprodex (Ciprofloxacin 0.3%; dexamethasone 0.1% ) DRUG

4 gtt BID (twice a day)

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

Ciprodex

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Shire: lead

Study Sites (1)

LBJ Tropical Medical Center, Department of Otolaryngology

Pago Pago, 96799, American Samoa

Location

MeSH Terms

Conditions

Otitis

Interventions

Dexamethasone; Ciprofloxacin

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2009
• First Posted: August 19, 2009
• Study Start: August 31, 2009
• Primary Completion: June 30, 2010
• Study Completion: June 30, 2010
• Last Updated: June 14, 2021

Record last verified: 2021-06

Locations

AM (1)