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
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Externa
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.
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
No
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
No
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
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