A Therapeutic Equivalence Study Between Two Formulations of the Combination Ciprofloxacin Hydrochloride and Hydrocortisone
Information source: Farmoquimica S.A.
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Otitis External
Intervention: Cipro HC (Drug); Ciprofloxacin Hydrochloride and Hydrocortis (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: Farmoquimica S.A.
Summary
The objective of this study is to compare the therapeutic equivalence of the test product
containing 2 mg/mL hydrochloride associated with ciprofloxacin 10 mg/mL of hydrocortisone
with the product Reference Cipro HC®, in patients with acute external otitis.
Clinical Details
Official title: A Therapeutic Equivalence Study Between Two Formulations of the Combination of 2 mg / mL of Ciprofloxacin Hydrochloride and 10 mg / mL Hydrocortisone Ear Suspension in Patients With Acute Otitis Externa.
Study design: Treatment, Randomized, Open Label, Parallel Assignment, Bio-availability Study
Primary outcome: to reduce pain, swelling and otorrhea.Identify the side effects of medication
Eligibility
Minimum age: 3 Years.
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 non intact tympanic membrane;
- Bilateral Acute Otitis Externa;
- Pregnant or lactating patients;
- Overt fungal Acute Otitis Externa;
- 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
Additional Information
Starting date: January 2010
Last updated: September 18, 2009
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