A Therapeutic Equivalence Study Between Two Formulations of the Combination Ciprofloxacin Hydrochloride and Hydrocortisone

This study is not yet open for participant recruitment.

Verified by Farmoquimica S.A., September 2009

First Received: September 18, 2009 No Changes Posted

Sponsor:	Farmoquimica S.A.
Information provided by:	Farmoquimica S.A.
ClinicalTrials.gov Identifier:	NCT00980876

Purpose

The objective of this study is to compare the therapeutic equivalence of the test product containing 2 mg/mL hydrochloride associated with ciprofloxacin 10 mg/mL of hydrocortisone with the product Reference Cipro HC®, in patients with acute external otitis.

Condition	Intervention	Phase
Acute Otitis External	Drug: Cipro HC Drug: Ciprofloxacin Hydrochloride and Hydrocortis	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment, Bio-availability Study
Official Title:	A Therapeutic Equivalence Study Between Two Formulations of the Combination of 2 mg / mL of Ciprofloxacin Hydrochloride and 10 mg / mL Hydrocortisone Ear Suspension in Patients With Acute Otitis Externa.

Resource links provided by NLM:

Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Ciprofloxacin Ciprofloxacin hydrochloride Hydrocortamate Ciprofloxacin lactate Hydrocortisone 21-sodium succinate Hydrocortisone cypionate Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

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

Primary Outcome Measures:

to reduce pain, swelling and otorrhea. [ Designated as safety issue: No ]
Identify the side effects of medication

Estimated Enrollment:	116
Study Start Date:	January 2010

Arms	Assigned Interventions
Cipro HC: Active Comparator	Drug: Cipro HC
Ciprofloxacin Hydrochloride and Hydrocortis: Experimental	Drug: Ciprofloxacin Hydrochloride and Hydrocortis

Eligibility

Ages Eligible for Study:	3 Years 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 non intact tympanic membrane;
Bilateral Acute Otitis Externa;
Pregnant or lactating patients;
Overt fungal Acute Otitis Externa;
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

No Contacts or Locations Provided

More Information

No publications provided

Responsible Party:	Scentryphar Clinical Research ( Eduardo Abib Junior )
Study ID Numbers:	STPh 09/08
Study First Received:	September 18, 2009
Last Updated:	September 18, 2009
ClinicalTrials.gov Identifier:	NCT00980876 History of Changes
Health Authority:	Brazil: Ethics Committee

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Anti-Infective Agents
Otorhinolaryngologic Diseases
Hydrocortisone
Cortisol succinate
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Ear Diseases

Pharmacologic Actions
Ciprofloxacin
Therapeutic Uses
Otitis
Hydrocortisone acetate
Otitis Externa
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on February 08, 2010