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Last Updated: December 10, 2019

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CLINICAL TRIALS PROFILE FOR CIPRODEX

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All Clinical Trials for CIPRODEX

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00945802 FST-201 In The Treatment of Acute Otitis Externa Terminated Shire Phase 3 2009-07-01 The objective of this study is to evaluate the efficacy of FST-201 compared to Ciprodex in the treatment of acute otitis externa. This trial is designed to enable filing of a New Drug Application in support of FST-201 for the indication of acute otitis externa.
NCT00956748 N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media Not yet recruiting St. Paul's Hospital, Canada Phase 4 2016-06-01 Chronic suppurative otitis media (CSOM) can be particularly difficult to treat as a number of patients do not respond to routine antibiotic or surgical treatments. The current treatment involves administering combination antibiotic anti-inflammatory ear drops such as Ciprodex (ciprofloxacin 0.3% / dexamethasone 0.1%). Although most patients experience a relief of symptoms, a fraction of patients remain refractory to treatment. Recent findings suggest that the addition of N-acetylcysteine (0.5-2%) to Ciprodex is a superior treatment for otitis media with effusion compared to the use of Ciprodex alone.
NCT00961675 FST-201 in the Treatment of Acute Otitis Externa Completed Shire Phase 3 2009-08-01 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.
NCT01027494 Topical Treatment of Acute Otitis Media Through Tympanostomy Tubes (AOMT) and Its Effect on Microbial Flora Completed Alcon Research Phase 3 2009-12-01 The purpose of this observational study was to evaluate the effects of a topical fluoroquinolone (antibiotic) instilled into the otic (ear) canal to treat Acute Otitis Media through Tympanostomy Tubes (AOMT) on selected bacterial species on the skin near the ear, in the nose, and in the throat.
NCT01359098 Efficacy and Safety of Once-Daily Ciprodexa Otic Foam Compared to Twice-daily Ciprodex Ear Drops in Acute Otitis Externa Completed Otic Pharma Phase 2 2011-07-01 The purpose of this study is to assess the Safety and Efficacy of Ciprodexa Foam (0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam), used once-a-day for 7 days for the treatment of Acute Diffuse Otitis Externa, compared to Ciprodex otic suspension used twice daily for 7 days.
NCT01908803 Proof-of-Concept Study of a Single Application of an Investigational Otic Suspension in Treatment of Acute Otitis Media With Tympanostomy Tubes Terminated Alcon Research Phase 2 2013-12-01 The purpose of this study is to evaluate a single application of AL-60371/AL-817 Otic Suspension relative to ototopical CIPRODEX for microbiological success at Day 8 and time to cessation of otorrhea.
NCT01910155 A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa Terminated Novum Pharmaceutical Research Services Phase 3 2013-07-01 The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par Pharmaceutical Companies, Inc.) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis externa.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for CIPRODEX

Condition Name

Condition Name for CIPRODEX
Intervention Trials
Acute Otitis Externa 3
Otitis Externa 2
Otorrhea 2
Acute Otitis Media 2
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Condition MeSH

Condition MeSH for CIPRODEX
Intervention Trials
Otitis 9
Otitis Media 5
Otitis Externa 5
Otitis Media with Effusion 1
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Clinical Trial Locations for CIPRODEX

Trials by Country

Trials by Country for CIPRODEX
Location Trials
United States 32
Canada 1
Puerto Rico 1
Israel 1
American Samoa 1
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Trials by US State

Trials by US State for CIPRODEX
Location Trials
North Carolina 3
Florida 3
Texas 3
Ohio 2
Arizona 2
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Clinical Trial Progress for CIPRODEX

Clinical Trial Phase

Clinical Trial Phase for CIPRODEX
Clinical Trial Phase Trials
Phase 4 2
Phase 3 6
Phase 2 2
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Clinical Trial Status

Clinical Trial Status for CIPRODEX
Clinical Trial Phase Trials
Terminated 4
Completed 3
Not yet recruiting 2
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Clinical Trial Sponsors for CIPRODEX

Sponsor Name

Sponsor Name for CIPRODEX
Sponsor Trials
Alcon Research 2
Shire 2
Par Pharmaceutical, Inc. 2
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Sponsor Type

Sponsor Type for CIPRODEX
Sponsor Trials
Industry 10
Other 2
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