Back to results

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

Primary Purpose

Otitis Externa

Status

Completed

Phase

Phase 3

Locations

Brazil

Study Type

Interventional

Intervention

Cipro HC

Ciprofloxacin HCl and Hydrocortisone

About this trial

This is an interventional treatment trial for Otitis Externa

Eligibility Criteria

1 Year - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Clínica Quiron

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Cipro HC

Ciprofloxacin HCl and Hydrocortisone

Arm Description

Reference product

Test product

Outcomes

Primary Outcome Measures

Cure (reduced pain, swelling and otorrhea)

Secondary Outcome Measures

Identification of possible side effects

Full Information

NCT ID

NCT00980876

First Posted

September 18, 2009

Last Updated

April 16, 2015

Sponsor

Farmoquimica S.A.

Collaborators

Pharmagenix Projetos em Medicina Farmacêutica Ltda.

1. Study Identification

Unique Protocol Identification Number

NCT00980876

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2012

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

January 2015 (Actual)

Study Completion Date

January 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Farmoquimica S.A.

Collaborators

Pharmagenix Projetos em Medicina Farmacêutica Ltda.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Otitis Externa

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

224 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cipro HC

Arm Type

Active Comparator

Arm Description

Reference product

Arm Title

Ciprofloxacin HCl and Hydrocortisone

Arm Type

Experimental

Arm Description

Test product

Intervention Type

Drug

Intervention Name(s)

Cipro HC

Intervention Description

Cipro HC (Ciprofloxacin HCl and Hydrocortisone)

Intervention Type

Drug

Intervention Name(s)

Ciprofloxacin HCl and Hydrocortisone

Other Intervention Name(s)

Otociriax

Intervention Description

Ciprofloxacin Hydrochloride and Hydrocortisone

Primary Outcome Measure Information:

Title

Cure (reduced pain, swelling and otorrhea)

Time Frame

7 days

Secondary Outcome Measure Information:

Title

Identification of possible side effects

Time Frame

7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Agricio N. Crespo, Phd

Organizational Affiliation

Clínica Quiron

Official's Role

Principal Investigator

Facility Information:

Facility Name

Clínica Quiron

City

Campinas

State/Province

São Paulo

ZIP/Postal Code

13087-000

Country

Brazil

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs