A Phase 3 interventional study of Cipro HC and Ciprofloxacin HCl and Hydrocortisone in Otitis Externa, sponsored by Farmoquimica S.A.. Completed at 1 site in Brazil. Open to participants aged 1 Year to 70 Years. Per ClinicalTrials.gov, last updated 2015-04-17.
Sponsored by Farmoquimica S.A. · Phase 3, Interventional, and Treatment
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.
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.
22 studies on the registry are indexed under Otitis Externa; 1 is open to participants now.
This study's enrollment of 224 is above the median of 100 across 20 interventional studies indexed under Otitis Externa.
Browse Otitis Externa studies →Farmoquimica S.A. is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reference product
Drug: Cipro HC
Test product
Drug: Ciprofloxacin HCl and Hydrocortisone
Cipro HC (Ciprofloxacin HCl and Hydrocortisone)
Drug pages: Ciprofloxacin · Hydrocortisone
Ciprofloxacin Hydrochloride and Hydrocortisone
Also known as: Otociriax
Cure (reduced pain, swelling and otorrhea)
Time frame: 7 days
Identification of possible side effects
Time frame: 7 days
The record gives a start of Apr 2012, a primary completion of Jan 2015 and a completion of Jan 2015. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Mar 2012. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ciprofloxacin · Hydrocortisone
Farmoquimica S.A.