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

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00980876

Enrollment

224

Registered

2009-09-21

Start date

2012-04-30

Completion date

2015-01-31

Last updated

2015-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Externa

Brief 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.

Interventions

DRUGCipro HC

Cipro HC (Ciprofloxacin HCl and Hydrocortisone)

DRUGCiprofloxacin HCl and Hydrocortisone

Ciprofloxacin Hydrochloride and Hydrocortisone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Years to 70 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Cure (reduced pain, swelling and otorrhea)	7 days

Secondary

Measure	Time frame
Identification of possible side effects	7 days

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026