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

Farmoquimica

Status and phase

Completed

Phase 3

Conditions

Otitis Externa

Treatments

Drug: Ciprofloxacin HCl and Hydrocortisone

Drug: Cipro HC

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00980876

STPh 09/08

Details and patient eligibility

About

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.

Full 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.

Enrollment

224 patients

Sex

All

Ages

1 to 70 years old

Volunteers

No 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.