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

Phase 3

Completed

• Conditions: Acute Otitis Media
• Interventions: Drug: DF289; Drug: DF277; Drug: DF289 plus DF277

• Registration Number: NCT01404611
• Lead Sponsor: Salvat

Brief Summary

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

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-07-22
• Study First Submitted QC: 2011-07-27
• Study First Posted: 2011-07-28
• Primary Completion: 2013-05
• Study Completion: 2013-06
• Results First Submitted: 2015-07-23
• Status Verified: 2015-10
• Results First Submitted QC: 2015-10-22
• Results First Posted: 2015-11-23
• Last Update Submitted: 2017-10-03
• Last Update Posted: 2017-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 331

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DF289	DF289	Ear drops
DF277	DF277	Ear drops
DF289 plus DF277	DF289 plus DF277	Ear drops

Primary Outcome Measures

Name	Time	Method
Time to Cessation of Otorrhea	From baseline until the end of the study (up to 22 days)

Trial Locations

Locations (1)

Laboratorios SALVAT S.A.; 🇪🇸 Esplugues de Llobregat, Barcelona, Spain