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| NCT00956748 ↗ | N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media | Withdrawn | St. Paul's Hospital, Canada | Phase 4 | 2019-11-29 | Chronic suppurative otitis media (CSOM) can be particularly difficult to treat as a number of patients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. |
| NCT01910155 ↗ | A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa | Terminated | Par Pharmaceutical, Inc. | 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 | >Sponsor | >Phase | >Start Date | >Summary |
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