NCT00980876

A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 224 (actual)
• Sponsor: Farmoquimica S.A. · Industry
• Sex: All
• Age: 1 Year – 70 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to compare the efficacy and safety profiles of the test product containing 2 mg/mL ciprofloxacin hydrochloride associated with 10 mg/mL of hydrocortisone with the reference product Cipro HC®, in patients with acute otitis externa.

Detailed description

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.

Conditions

• Otitis Externa

Interventions

Type	Name	Description
DRUG	Cipro HC	Cipro HC (Ciprofloxacin HCl and Hydrocortisone)
DRUG	Ciprofloxacin HCl and Hydrocortisone	Ciprofloxacin Hydrochloride and Hydrocortisone

Timeline

• Start date: 2012-04-01
• Primary completion: 2015-01-01
• Completion: 2015-01-01
• First posted: 2009-09-21
• Last updated: 2015-04-17

Locations

1 site across 1 country: Brazil