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

Phase 3

Completed

• Conditions: Otitis Externa
• Interventions: Drug: Ciprofloxacin HCl and Hydrocortisone; Drug: Cipro HC

• Registration Number: NCT00980876
• Lead Sponsor: Farmoquimica S.A.

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.

Study Timeline

• Study First Submitted: 2009-09-18
• Study First Submitted QC: 2009-09-18
• Study First Posted: 2009-09-21
• Status Verified: 2012-03
• Study Start: 2012-04
• Primary Completion: 2015-01
• Study Completion: 2015-01
• Last Update Submitted: 2015-04-16
• Last Update Posted: 2015-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

• Informed of the nature of the study and given written informed consent;
• Patients with acute otitis externa;
• Intact tympanic membrane.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ciprofloxacin HCl and Hydrocortisone	Ciprofloxacin HCl and Hydrocortisone	Test product
Cipro HC	Cipro HC	Reference product

Primary Outcome Measures

Name	Time	Method
Cure (reduced pain, swelling and otorrhea)	7 days

Secondary Outcome Measures

Name	Time	Method
Identification of possible side effects	7 days

Trial Locations

Locations (1)

Clínica Quiron; 🇧🇷 Campinas, São Paulo, Brazil