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Completed

NCT Number: NCT00980876

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

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.

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Key information

Conditions

Otitis Externa Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

1 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clínica Quiron

Campinas, São Paulo, 13087-000, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cipro HC

Drug

Cipro HC (Ciprofloxacin HCl and Hydrocortisone)

Ciprofloxacin HCl and Hydrocortisone

Drug

Ciprofloxacin Hydrochloride and Hydrocortisone

Other names: Otociriax

Primary outcomes

  1. Cure (reduced pain, swelling and otorrhea)

    Time frame: 7 days

Secondary outcomes

  1. Identification of possible side effects

    Time frame: 7 days

Sponsors and collaborators

Lead sponsor

Farmoquimica S.A.

Industry

Collaborators

  • Pharmagenix Projetos em Medicina Farmacêutica Ltda.

Registry information

Official study 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.

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Sep 21, 2009
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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