A Comparative Study Between Two Formulations of the Ciprofloxacin Hydrochloride + Hydrocortisone Otic Suspension - Full Text View

Sponsor:	Farmoquimica S.A.
Collaborator:	Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Information provided by (Responsible Party):	Farmoquimica S.A.
ClinicalTrials.gov Identifier:	NCT00980876

Purpose

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.

Condition	Intervention	Phase
Otitis Externa	Drug: Cipro HC Drug: Ciprofloxacin HCl and Hydrocortisone	Phase 3

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

Resource links provided by NLM:

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone Sodium Succinate Hydrocortisone cypionate Ciprofloxacin Ciprofloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Farmoquimica S.A.:

Primary Outcome Measures:

Cure (reduced pain, swelling and otorrhea) [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Identification of possible side effects [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	224
Study Start Date:	April 2012
Estimated Study Completion Date:	July 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Cipro HC Reference product	Drug: Cipro HC Cipro HC (Ciprofloxacin HCl and Hydrocortisone) Other Name: Cipro HC
Experimental: Ciprofloxacin HCl and Hydrocortisone Test product	Drug: Ciprofloxacin HCl and Hydrocortisone Ciprofloxacin Hydrochloride and Hydrocortisone Other Name: Otociriax

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

Ages Eligible for Study:	1 Year to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00980876

Locations

Brazil
Clínica Quiron	Not yet recruiting
Campinas, São Paulo, Brazil, 13087-000
Contact: Agricio N. Crespo, Phd 551932420088 ancrespo@uol.com.br

Sponsors and Collaborators

Farmoquimica S.A.

Pharmagenix Projetos em Medicina Farmacêutica Ltda.

Investigators

Principal Investigator:

Agricio N. Crespo, Phd

Clínica Quiron

More Information

No publications provided

Responsible Party:	Farmoquimica S.A.
ClinicalTrials.gov Identifier:	NCT00980876 History of Changes
Other Study ID Numbers:	STPh 09/08
Study First Received:	September 18, 2009
Last Updated:	March 6, 2012
Health Authority:	Brazil: Ethics Committee

Additional relevant MeSH terms:

Otitis Externa
Otitis
Ear Diseases
Otorhinolaryngologic Diseases
Ciprofloxacin
Ciprofloxacin, hydrocortisone drug combination
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone

Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Anti-Inflammatory Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 23, 2012