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

The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and effective in treating middle ear infections in children with ear tubes.

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Key information

Conditions

Acute Otitis Media Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

6 month–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Laboratorios Salvat, S.A.

Esplugues de Llobregat, Barcelona, 08950, Spain

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

DF289

Drug

Ear drops

DF277

Drug

Ear drops

DF289 plus DF277

Drug

Ear drops

Primary outcomes

Time to Cessation of Otorrhea

Time frame: From baseline until the end of the study ( up to 22 days)

Sponsors and collaborators

Lead sponsor

Salvat

Industry

Registry information

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Jul 18, 2011
Registry last updated: Oct 22, 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.

Published trials that share one or more normalized conditions with this study.

Completed