A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
Information source: Farmoquimica S.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Otitis Externa
Intervention: Cipro HC (Drug); Ciprofloxacin HCl and Hydrocortisone (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Farmoquimica S.A. Official(s) and/or principal investigator(s):
Agricio N. Crespo, Phd, Principal Investigator, Affiliation: ClÃnica Quiron
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Cure (reduced pain, swelling and otorrhea)
Secondary outcome: Identification of possible side effects
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.
Eligibility
Minimum age: 1 Year.
Maximum age: 70 Years.
Gender(s): Both.
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.
Locations and Contacts
ClÃnica Quiron, Campinas, São Paulo 13087-000, Brazil
Additional Information
Starting date: April 2012
Last updated: April 16, 2015
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