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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00980876
Recruitment Status : Completed
First Posted : September 21, 2009
Last Update Posted : April 17, 2015
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Information provided by (Responsible Party):
Farmoquimica S.A.

Brief 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.

Condition or disease Intervention/treatment Phase
Otitis Externa Drug: Cipro HC Drug: Ciprofloxacin HCl and Hydrocortisone Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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.
Study Start Date : April 2012
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015

Arm Intervention/treatment
Active Comparator: Cipro HC
Reference product
Drug: Cipro HC
Cipro HC (Ciprofloxacin HCl and Hydrocortisone)

Experimental: Ciprofloxacin HCl and Hydrocortisone
Test product
Drug: Ciprofloxacin HCl and Hydrocortisone
Ciprofloxacin Hydrochloride and Hydrocortisone
Other Name: Otociriax

Primary Outcome Measures :
  1. Cure (reduced pain, swelling and otorrhea) [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Identification of possible side effects [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00980876

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Clínica Quiron
Campinas, São Paulo, Brazil, 13087-000
Sponsors and Collaborators
Farmoquimica S.A.
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
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Principal Investigator: Agricio N. Crespo, Phd Clínica Quiron

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Responsible Party: Farmoquimica S.A. Identifier: NCT00980876     History of Changes
Other Study ID Numbers: STPh 09/08
First Posted: September 21, 2009    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: March 2012
Additional relevant MeSH terms:
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Ciprofloxacin, hydrocortisone drug combination
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Otitis Externa
Ear Diseases
Otorhinolaryngologic Diseases
Anti-Inflammatory Agents
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors