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.
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Farmoquimica S.A.
- Enrollment
- 224
- Locations
- 1
- Primary Endpoint
- Cure (reduced pain, swelling and otorrhea)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 1 Year to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
- •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.
Arms & Interventions
Cipro HC
Reference product
Intervention: Cipro HC (Drug)
Ciprofloxacin HCl and Hydrocortisone
Test product
Intervention: Ciprofloxacin HCl and Hydrocortisone (Drug)
Outcomes
Primary Outcomes
Cure (reduced pain, swelling and otorrhea)
Time Frame: 7 days
Secondary Outcomes
- Identification of possible side effects(7 days)