Trial record 3 of 5 for:    Open Studies | "Otitis Externa"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Farmoquimica S.A..
Recruitment status was  Not yet recruiting
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hydrocortisone acetate
Hydrocortisone 17-butyrate 21-propionate
Cortisol succinate
Hydrocortisone
Hydrocortisone-17-butyrate
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Inflammatory Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on October 01, 2014