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

This study is not yet open for participant recruitment.
Verified March 2012 by Farmoquimica S.A.
Sponsor:
Collaborator:
Pharmagenix Projetos em Medicina Farmacêutica Ltda.
Information provided by (Responsible Party):
Farmoquimica S.A.
ClinicalTrials.gov Identifier:
NCT00980876
First received: September 18, 2009
Last updated: March 6, 2012
Last verified: March 2012
History of Changes
  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:

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 17-butyrate 21-propionate
Hydrocortisone
 Hydrocortisone-17-butyrate
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Infective Agents
Therapeutic Uses
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on May 19, 2013