Drugs / Ciprodex
Ciprodex
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | CIPRODEX | — | 2003-07-18 | fda.gov ↗ |
Trials 1 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 4 | NCT00956748 | Nov 2019 | discharging ear, otitis media | St. Paul's Hospital, Canada | Withdrawn | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 31 trial | ||||||
| Phase 3 | NCT00961675 Comparator | Aug 2009 → Jun 2010 | acute otitis externa | Shire | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT03347461 Comparator | Oct 2018 → Jun 2019 | discharging ear, otitis media with effusion | Boston Medical Center | Withdrawn | No outcome recorded |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Ciprodex | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00961675 ↗ |
| Known as | CIPRODEX (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension | “CIPRODEX® (ciprofloxacin 0.3% and dexamethasone 0.1%) Sterile Otic Suspension” NCT00961675 ↗ |
| Route | Topical | “ciprofloxacin 0.3% / dexamethasone 0.1% otic solution” NCT00956748 ↗ |