Trial | NCT00980876  Report issue

Title

A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension
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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    urea ciprofloxacin ...

  • Study Participants

    224
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.
Study Started
Apr 30
2012
Primary Completion
Jan 31
2015
Study Completion
Jan 31
2015
Last Update
Apr 17
2015
Estimate

Drug Cipro HC

Cipro HC (Ciprofloxacin HCl and Hydrocortisone)

Drug Ciprofloxacin HCl and Hydrocortisone

Ciprofloxacin Hydrochloride and Hydrocortisone

  • Other names: Otociriax

Cipro HC Active Comparator

Reference product

Ciprofloxacin HCl and Hydrocortisone Experimental

Test product

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.
No Results Posted