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

• Status: Completed
• Trial end date: 2015-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Farmoquimica S.A.
• Collaborator: Pharmagenix Projetos em Medicina Farmacêutica Ltda.
• Treatments: Ciprofloxacin; Ciprofloxacin, hydrocortisone drug combination; Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate

Criteria

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.