NCT00980876

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
224

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed
2.5 years until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

April 17, 2015

Status Verified

March 1, 2012

Enrollment Period

2.8 years

First QC Date

September 18, 2009

Last Update Submit

April 16, 2015

Conditions

Otitis Externa

Outcome Measures

Primary Outcomes (1)

  • Cure (reduced pain, swelling and otorrhea)

    7 days

Secondary Outcomes (1)

  • Identification of possible side effects

    7 days

Study Arms (2)

Cipro HC

ACTIVE COMPARATOR

Reference product

Drug: Cipro HC

Ciprofloxacin HCl and Hydrocortisone

EXPERIMENTAL

Test product

Drug: Ciprofloxacin HCl and Hydrocortisone

Interventions

Cipro HCDRUG

Cipro HC (Ciprofloxacin HCl and Hydrocortisone)

Cipro HC
Ciprofloxacin HCl and HydrocortisoneDRUG

Ciprofloxacin Hydrochloride and Hydrocortisone

Also known as: Otociriax
Ciprofloxacin HCl and Hydrocortisone

Eligibility Criteria

Age1 Year - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Informed of the nature of the study and given written informed consent;
  • Patients with acute otitis externa;
  • Intact tympanic membrane.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clínica Quiron

Campinas, São Paulo, 13087-000, Brazil

Location

MeSH Terms

Conditions

Otitis Externa

Interventions

ciprofloxacin, hydrocortisone drug combinationCiprofloxacinHydrocortisone

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Fluoroquinolones4-QuinolonesQuinolonesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds11-HydroxycorticosteroidsHydroxycorticosteroidsAdrenal Cortex HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists17-Hydroxycorticosteroids

Study Officials

  • Agricio N. Crespo, Phd

    Clínica Quiron

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 21, 2009

Study Start

April 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

April 17, 2015

Record last verified: 2012-03

Locations

BR(1)