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Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

NCT ID: NCT01404611

Last Updated: 2017-10-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

331 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating middle ear infections in children with ear tubes.

Detailed Description

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Conditions

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Acute Otitis Media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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DF289

Ear drops

Group Type ACTIVE_COMPARATOR

DF289

Intervention Type DRUG

Ear drops

DF277

Ear drops

Group Type ACTIVE_COMPARATOR

DF277

Intervention Type DRUG

Ear drops

DF289 plus DF277

Ear drops

Group Type EXPERIMENTAL

DF289 plus DF277

Intervention Type DRUG

Ear drops

Interventions

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DF289

Ear drops

Intervention Type DRUG

DF277

Ear drops

Intervention Type DRUG

DF289 plus DF277

Ear drops

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 6 months to 12 years
* ear tube in the ear which will be treated
* otorrhea for 3 weeks or less
* moderate or severe otorrhea

Exclusion Criteria

* other ear diseases
Minimum Eligible Age

6 Months

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Salvat

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Laboratorios SALVAT S.A.

Esplugues de Llobregat, Barcelona, Spain

Site Status

Countries

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Spain

References

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Spektor Z, Pumarola F, Ismail K, Lanier B, Hussain I, Ansley J, Butehorn HF 3rd, Esterhuizen K, Byers J, Douglis F, Lansford B, Hernandez FJ. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone in Otitis Media With Tympanostomy Tubes in Pediatric Patients: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Apr 1;143(4):341-349. doi: 10.1001/jamaoto.2016.3537.

Reference Type DERIVED
PMID: 28006041 (View on PubMed)

Other Identifiers

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DF289III/10IA04

Identifier Type: -

Identifier Source: org_study_id