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

Information source: Farmoquimica S.A.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Otitis Externa

Intervention: Cipro HC (Drug); Ciprofloxacin HCl and Hydrocortisone (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Farmoquimica S.A.

Official(s) and/or principal investigator(s):
Agricio N. Crespo, Phd, Principal Investigator, Affiliation: Clínica Quiron

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.

Clinical Details

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 Safety in Patients With Otitis Externa.

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Cure (reduced pain, swelling and otorrhea)

Secondary outcome: Identification of possible side effects

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.

Eligibility

Minimum age: 1 Year. 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 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.

Locations and Contacts

Clínica Quiron, Campinas, São Paulo 13087-000, Brazil
Additional Information

Starting date: April 2012
Last updated: April 16, 2015

Page last updated: August 23, 2015

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