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

NCT00980876 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2015-04-17

No results posted yet for this study

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.

Conditions

  • Otitis Externa

Interventions

DRUG

Cipro HC

Cipro HC (Ciprofloxacin HCl and Hydrocortisone)

DRUG

Ciprofloxacin HCl and Hydrocortisone

Ciprofloxacin Hydrochloride and Hydrocortisone

Sponsors & Collaborators

  • Pharmagenix Projetos em Medicina Farmacêutica Ltda.

    collaborator OTHER

  • Farmoquimica S.A.

    lead INDUSTRY

Principal Investigators

  • Agricio N. Crespo, Phd · Clínica Quiron

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2015-01-31
Completion
2015-01-31

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00980876 on ClinicalTrials.gov