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Last Updated: December 3, 2022

CLINICAL TRIALS PROFILE FOR CIPROFLOXACIN; DEXAMETHASONE


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All Clinical Trials for Ciprofloxacin; Dexamethasone

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00945802 ↗ FST-201 In The Treatment of Acute Otitis Externa Terminated Shire Phase 3 2009-07-31 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NCT00956748 ↗ N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media Withdrawn St. Paul's Hospital, Canada Phase 4 2019-11-29 Chronic suppurative otitis media (CSOM) can be particularly difficult to treat as a number of patients do not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 2009-08-31 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.
NCT01277016 ↗ A Trial for Systemic Light-chain (AL) Amyloidosis Completed European Myeloma Network Phase 3 2011-01-01 In this multi-center phase III trial, untreated patients diagnosed with AL who are not candidates for stem cell transplant with melphalan 200 mg/m2 are the target population. Stage I and II patients will be eligible. Stage III patients will be enrolled in an ancillary phase II study. Eligible patients will be stratified as cardiac stage I or stage II and then randomized to receive MDex or BMDex. Primary objective is to compare hematologic(clonal) response i.e. the rate of complete response (CR) + partial response (PR) defined according to the criteria of the International Society for Amyloidosis consensus.
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.
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 Ciprofloxacin; Dexamethasone

Condition Name

Condition Name for Ciprofloxacin; Dexamethasone
Intervention Trials
Acute Otitis Externa 3
Otitis Externa 2
Otitis 1
AL Amyloidosis 1
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Condition MeSH

Condition MeSH for Ciprofloxacin; Dexamethasone
Intervention Trials
Otitis 7
Otitis Externa 5
Endophthalmitis 2
Otitis Media 2
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Clinical Trial Locations for Ciprofloxacin; Dexamethasone

Trials by Country

Trials by Country for Ciprofloxacin; Dexamethasone
Location Trials
United States 49
Brazil 2
Puerto Rico 2
Canada 1
Israel 1
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Trials by US State

Trials by US State for Ciprofloxacin; Dexamethasone
Location Trials
Florida 4
Oregon 3
Ohio 3
North Carolina 3
California 3
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Clinical Trial Progress for Ciprofloxacin; Dexamethasone

Clinical Trial Phase

Clinical Trial Phase for Ciprofloxacin; Dexamethasone
Clinical Trial Phase Trials
Phase 4 2
Phase 3 6
Phase 2 4
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Clinical Trial Status

Clinical Trial Status for Ciprofloxacin; Dexamethasone
Clinical Trial Phase Trials
Completed 6
Terminated 3
Withdrawn 2
[disabled in preview] 3
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Clinical Trial Sponsors for Ciprofloxacin; Dexamethasone

Sponsor Name

Sponsor Name for Ciprofloxacin; Dexamethasone
Sponsor Trials
Shire 2
Novum Pharmaceutical Research Services 2
Par Pharmaceutical, Inc. 2
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Sponsor Type

Sponsor Type for Ciprofloxacin; Dexamethasone
Sponsor Trials
Other 12
Industry 11
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