Clinical trial NCT02216071: Comparative Efficacy and Safety of Ciprofloxacin 0.3% and Dexamethasone 0.1% in Acute Otitis Externa
Official title: A Phase 3, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study of the Comparative Efficacy and Safety of EXL CDOS in Subjects With Acute Otitis Externa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Otitis Externa
Lead sponsor: Exela Pharma Sciences, LLC.
Sponsor class: INDUSTRY
First posted: 2014-08-13
Enrollment: 499
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to demonstrate the clinical therapeutic non-inferiority of EXL CDOS to commercially available Ciprofloxacin 0.3% and Dexamethasone 0.1% Sterile Otic Suspension (Ciprodex®, Alcon) in the treatment of acute otitis externa (AOE) when administered twice daily for 7 days.

Detailed description: This was a Phase 3, multicenter, randomized, double-blind, active-controlled, parallel-group study in adults and children (age 6 months and older) with a diagnosis of AOE with a 2-day screening period followed by a 2-week participation period. Subjects were administered study drug, EXL CDOS or RLD, 4 drops in the affected ear(s) BID for 7 days. The primary endpoint, the proportion of subjects with a clinical AOE score of 0, was measured at the TOC Visit on Day 15.

Eligibility criteria: Inclusion Criteria:

1. Male or female, 6 months of age and over;
2. Clinically documented AOE consistent with the diagnostic guidelines of the American Academy of Otolaryngology-Head and Neck Surgery Foundation in 1 or both ears;
3. Inflammation and/or edema ≥2 on the AOE scale, and otorrhea and/or tenderness present;
4. AOE of \<4 weeks duration;
5. Intact tympanic membrane(s) in the treated ear(s);
6. Willingness to refrain from swimming through the TOC/ Visit 5;
7. For subjects with AOE associated with hearing aid use, willingness to discontinue the use of hearing aid(s) in the affected ear(s) through the TOC/Visit 5;
8. Ability to complete the study in compliance with the protocol;
9. For adult subjects, ability to understand and provide written informed consent; and
10. For pediatric subjects, a parent or legal guardian has provided written informed consent; and
11. For children age 6 and above, ability to understand and provide assent according to institutional requirements.

Exclusion Criteria:

1. Acute or chronic suppurative otitis media;
2. Post-tympanostomy tube acute otorrhea;
3. Malignant otitis externa;
4. Suspected or overt fungal or viral ear infection;
5. Congenital abnormalities or obstructive bony exostoses of the external auditory canal of the treated ear(s);
6. Seborrheic dermatitis or other dermatologic conditions of the external auditory canal of the treated ear(s) which could confound evaluation;
7. Mastoiditis or other suppurative infectious or non-infectious disorders of the treated ear(s);
8. Malignant tumors of the external auditory canal of the treated ear(s);
9. History of otologic surgery of the treated ear(s), with the exception of tympanic membrane surgery \>6 months prior to Baseline;
10. Four or more episodes of otitis externa (OE) in the previous year;
11. Uncontrolled diabetes mellitus;
12. Immunosuppressive disorder, including known Human Immunodeficiency Virus infection;
13. Renal insufficiency;
14. Hepatitis or hepatic insufficiency;
15. Receipt of systemic antibiotic concurrently or within 72 hours prior to Baseline;
16. Receipt of topical otic antibiotic within 24 hours prior to Baseline;
17. Use of systemic corticosteroid concurrently or within 30 days prior to Baseline;
18. Use of topical otic corticosteroids concurrently or within 7 days prior to Baseline;
19. Concurrent use of systemic or topical otic nonsteroidal or other anti-inflammatory drugs;
20. Use of topical vinegar, alcohol, or other astringent otic preparations concurrently or within 24 hours prior to Baseline;
21. Pregnancy, planned pregnancy, or lactation;
22. Known sensitivity or intolerance to quinolone antibacterial agents;
23. Previous participation in this trial;
24. Participation in another investigational drug or vaccine trial concurrently or within 30 days; or
25. Significant acute or chronic medical, neurologic, or psychiatric illness in the subject or parent/guardian that, in the judgment of the Principal Investigator, could compromise subject safety, limit the subject's ability to complete the study, and/or compromise the objectives of the study.

Primary outcomes:
measure: Number of Participants With Clinical Cure of AOE
timeFrame: 7 days after the completion of therapy; at Day 15 (+/- 1 day)
Secondary outcomes:
measure: Number of Participants With Microbiological Cure (MC)
timeFrame: 7 days after the completion of therapy; at Day 15 (+/- 1 day)
Other outcomes:
measure: Number of Participants With Adverse Events
timeFrame: Each monitoring visit through 15 +/- 1 days
Locations:
city: Birmingham
country: United States
facility: Birmingham Pediatric Associates
state: Alabama
city: Mesa
country: United States
facility: Desert Clinical Research/Clinical Research Advantage, Inc.
state: Arizona
city: Jonesboro
country: United States
facility: Children's Clinic of Jonesboro, PA
state: Arkansas
city: Jonesboro
country: United States
facility: NEA Baptist Clinic
state: Arkansas
city: Anaheim
country: United States
facility: Southland Clinical Research Center
state: California
city: Bellflower
country: United States
facility: Southland Clinical Reseach Center
state: California
city: Beverly Hills
country: United States
facility: Alessi Institute
state: California
city: Buena Park
country: United States
facility: American Clinical Trials
state: California
city: Los Angeles
country: United States
facility: MCS Clinical Trials
state: California
city: Sacramento
country: United States
facility: Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc
state: California
city: Sacramento
country: United States
facility: Benchmark Research
state: California
city: Centennial
country: United States
facility: Clinix Health Services of Colorado/Clinical Research Advantage, Inc.
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado ENT & Allergy
state: Colorado
city: Colorado Springs
country: United States
facility: Colorado Springs Health Partners/Clinical Research Advantage, Inc.
state: Colorado
city: Hialeah
country: United States
facility: Direct Helpers Medical Center
state: Florida
city: Hialeah
country: United States
facility: Palm Springs Research Institute
state: Florida
city: Miami
country: United States
facility: Abel & Buchheim PR, Inc.
state: Florida
city: Miami
country: United States
facility: Integrity Clinical Trials, LLC
state: Florida
city: Marietta
country: United States
facility: Pediatrics & Adolescent Medicine, PA
state: Georgia
city: Marietta
country: United States
facility: Urban Family Practice/Clinical Research Advantage
state: Georgia
city: Wichita
country: United States
facility: Professional Research Network of Kansas, LLC
state: Kansas
city: Eunice
country: United States
facility: Horizon Research Group, LLC
state: Louisiana
city: Woburn
country: United States
facility: Woburn Pediatric Associates
state: Massachusetts
city: Bellevue
country: United States
facility: Pioneer Clinical Research
state: Nebraska
city: Las Vegas
country: United States
facility: Clinical Research Center for Nevada, LLC
state: Nevada
city: Morganville
country: United States
facility: ProMetrix Clinical Studies
state: New Jersey
city: Whitehouse Station
country: United States
facility: Whitehouse Station Family Medicine
state: New Jersey
city: Asheboro
country: United States
facility: Asheboro Research Associates
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Ear, Nose, and Throat Associates
state: North Carolina
city: Cincinnati
country: United States
facility: Sterling Research Group, Ltd
state: Ohio
city: Dayton
country: United States
facility: Hometown Urgent Care and Research
state: Ohio
city: Gresham
country: United States
facility: Cyn3rgy Research
state: Oregon
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Houston
country: United States
facility: Gulf Coast Medical Research
state: Texas
city: Missouri City
country: United States
facility: Gulf Coast Medical Research
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research
state: Texas
city: Splendora
country: United States
facility: Mercury Clinical Research, Inc
state: Texas
city: Sugar Land
country: United States
facility: Gulf Coast Medical Research
state: Texas
city: Clinton
country: United States
facility: Ericksen Research & Development
state: Utah
city: Saint George
country: United States
facility: Chyrsalis Clinical Research
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research/First Med East
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research/Foothill Family Clinic South
state: Utah
city: Burke
country: United States
facility: Pi-Coor Clinical Research, LLC
state: Virginia
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC
state: Virginia
city: Midlothian
country: United States
facility: Heugenot Pediatrics, PC
state: Virginia
city: Richland
country: United States
facility: Zain Research, LLC
state: Washington
city: Cidra
country: Puerto Rico
facility: Advance Medical Concepts, PSC
city: San Juan
country: Puerto Rico
facility: Clinical Research Puerto Rico
Study officials:
affiliation: BioStrategics Consulting Ltd
name: Michael H Silverman, MD
role: STUDY_CHAIR
References: