Status:
COMPLETED
A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
Lead Sponsor:
Farmoquimica S.A.
Collaborating Sponsors:
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Conditions:
Otitis Externa
Eligibility:
All Genders
1-70 years
Phase:
PHASE3
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 refere...
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...
Eligibility Criteria
Inclusion
- Informed of the nature of the study and given written informed consent;
- Patients with acute otitis externa;
- Intact tympanic membrane.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2015
Estimated Enrollment :
224 Patients enrolled
Trial Details
Trial ID
NCT00980876
Start Date
April 1 2012
End Date
January 1 2015
Last Update
April 17 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Clínica Quiron
Campinas, São Paulo, Brazil, 13087-000