Phase 3Terminated
A Bioequivalence Study of Two Ciprofloxacin/Dexamethasone Formulations in Patients With Otitis Externa
A Randomized, Double-Blind, Placebo-Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspension (Par) Compared to CIPRODEX® (Ciprofloxacin 0.3%/Dexamethasone 0.1%) Sterile Otic Suspension (Alcon) in the Treatment of Adults With Acute Bacterial Otitis Externa
- Sponsor
- Par Pharmaceutical, Inc. (Industry)
- Enrolment
- 455 enrolled
- Conditions
- Otitis Externa
- Interventions
- Ciprofloxacin/Dexamethasone; Ciprodex (R); Placebo
- Ages
- adults, older adults
- Registry
- NCT01910155
Full record on ClinicalTrials.gov
From the registry
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.
Primary outcomes
- Clinical Success
History
Last registry update
Study completion
Primary completion
Registered
Started