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

Farmoquimica S.A.224 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

224

Conditions

Otitis Externa

Interventions

Cipro HCDRUG

Cipro HC (Ciprofloxacin HCl and Hydrocortisone)

Ciprofloxacin HCl and HydrocortisoneDRUG

Ciprofloxacin Hydrochloride and Hydrocortisone

Eligibility

Sex: ALLMin age: 1 YearMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Informed of the nature of the study and given written informed consent; * Patients with acute otitis externa; * Intact tympanic membrane. Exclusion Criteria: * Known allergy or sensitivity to Ciprofloxacin Hydrochloride and Hydrocortisone; * Patient has the tympanic membrane not intact; * Diabetes * Bilateral Acute Otitis Externa; * Pregnant or lactating patients; * Overt fungal Acute Otitis Externa; * Other diseases of the ear * Current Infection requiring systemic antimicrobial therapy. * Current enrollment in an investigational drug or device study or participation in such a study within 30 days of entry into this study.

Locations (1)

Clínica Quiron

Campinas, São Paulo, Brazil

Outcomes

Primary Outcomes

Cure (reduced pain, swelling and otorrhea)

Time frame: 7 days

Secondary Outcomes

Identification of possible side effects

Time frame: 7 days

Data from ClinicalTrials.gov

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