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

Tracking Information

First Received Date ^ICMJE

September 18, 2009

Last Updated Date

March 6, 2012

Start Date ^ICMJE

April 2012

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Cure (reduced pain, swelling and otorrhea) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

to reduce pain, swelling and otorrhea. [ Designated as safety issue: No ]
Identify the side effects of medication

Change History

Complete list of historical versions of study NCT00980876 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Identification of possible side effects [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Otitis Externa

Intervention ^ICMJE

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

Other Name: Cipro HC
Drug: Ciprofloxacin HCl and Hydrocortisone
Ciprofloxacin Hydrochloride and Hydrocortisone

Other Name: Otociriax

Study Arms

Active Comparator: Cipro HC
Reference product

Intervention: Drug: Cipro HC
Experimental: Ciprofloxacin HCl and Hydrocortisone
Test product

Intervention: Drug: Ciprofloxacin HCl and Hydrocortisone

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

224

Estimated Completion Date

July 2013

Estimated Primary Completion Date

May 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

1 Year to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT00980876

Other Study ID Numbers ^ICMJE

STPh 09/08

Has Data Monitoring Committee

Responsible Party

( Farmoquimica S.A. )

Study Sponsor ^ICMJE

Farmoquimica S.A.

Collaborators ^ICMJE

Pharmagenix Projetos em Medicina Farmacêutica Ltda.

Investigators ^ICMJE

Principal Investigator:

Agricio N. Crespo, Phd

Clínica Quiron

Information Provided By

Farmoquimica S.A.

Verification Date

March 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP