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Bioequivalence of Two Ciprofloxacin 0.3%/Dexamethasone 0.1% Sterile Otic Suspensions in Otitis Media in Children With Tympanostomy Tubes

NCT01994642 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 203

Last updated 2017-09-26

No results posted yet for this study

Summary

The objective of this study is to compare the relative efficacy and safety of the test formulation of ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension (Par) to the already-marketed formulation CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%) sterile otic suspension (Alcon) in the treatment of acute bacterial otitis media in children with patent tympanostomy tubes.

Conditions

  • Otitis Media in Patients With Tympanostomy Tubes

Interventions

DRUG

Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension

DRUG

CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)

DRUG

Placebo Sterile Otic Suspension

Sponsors & Collaborators

  • Novum Pharmaceutical Research Services

    collaborator INDUSTRY

  • Par Pharmaceutical, Inc.

    lead INDUSTRY

Principal Investigators

  • Chandra Vattikonda, Ph.D. · Par Pharamceutical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-03-31
Completion
2015-03-31

Countries

  • United States

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 NCT01994642 on ClinicalTrials.gov