Clinical Trial: A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Saf
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 Summary:
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.
Sponsor: Farmoquimica S.A.
Current Primary Outcome: Cure (reduced pain, swelling and otorrhea) [ Time Frame: 7 days ]
Original Primary Outcome:
- to reduce pain, swelling and otorrhea.
- Identify the side effects of medication
Current Secondary Outcome: Identification of possible side effects [ Time Frame: 7 days ]
Original Secondary Outcome:
Information By: Farmoquimica S.A.
Dates:
Date Received: September 18, 2009
Date Started: April 2012
Date Completion:
Last Updated: April 16, 2015
Last Verified: March 2012
