A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
|Otitis Externa||Drug: Cipro HC Drug: Ciprofloxacin HCl and Hydrocortisone||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Multicentric, Double Blind, Randomized, Parallel Comparative Study Between Ciprofloxacin HCl 2 mg/mL + Hydrocortisone 10 mg/mL Ear Suspension and Cipro HC®, for the Assessment of Efficacy and Safety in Patients With Otitis Externa.|
- Cure (reduced pain, swelling and otorrhea) [ Time Frame: 7 days ]
- Identification of possible side effects [ Time Frame: 7 days ]
|Study Start Date:||April 2012|
|Study Completion Date:||January 2015|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Cipro HC
Drug: Cipro HC
Cipro HC (Ciprofloxacin HCl and Hydrocortisone)
Experimental: Ciprofloxacin HCl and Hydrocortisone
Drug: Ciprofloxacin HCl and Hydrocortisone
Ciprofloxacin Hydrochloride and Hydrocortisone
Other Name: Otociriax
Phase III, non inferiority, multicentric, controlled, single blind, parallel-group, randomized study.
Population: 224 patients with external otitis , men and women aged between 1 - 70 years.
Primary endpoint: The primary endpoint of this study is the elimination of pain, swelling and otorrhea (cure).
Secondary endpoint: The endpoint will be the identification of the side effects of medication use.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00980876
|Campinas, São Paulo, Brazil, 13087-000|
|Principal Investigator:||Agricio N. Crespo, Phd||Clínica Quiron|