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

Otitis Externa Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00980876
• Other study ID #: STPh 09/08
• Status: Completed
• Phase: Phase 3
• First received: September 18, 2009
• Last updated: April 16, 2015
• Start date: April 2012
• Est. completion date: January 2015

Study information

• Verified date: March 2012
• Source: Farmoquimica S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otitis
• Otitis Externa

Intervention

Drug:
• Cipro HC
Cipro HC (Ciprofloxacin HCl and Hydrocortisone)
• Ciprofloxacin HCl and Hydrocortisone
Ciprofloxacin Hydrochloride and Hydrocortisone

Locations

Country	Name	City	State
Brazil	Clínica Quiron	Campinas	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Farmoquimica S.A.	Pharmagenix Projetos em Medicina Farmacêutica Ltda.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cure (reduced pain, swelling and otorrhea)		7 days	No
Secondary	Identification of possible side effects		7 days	Yes