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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Salvat

ClinicalTrials.gov Identifier:

NCT01395966

First received: July 8, 2011

Last updated: September 22, 2015

Last verified: September 2015

History of Changes

Purpose

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.

Condition	Intervention	Phase
Acute Otitis Media	Drug: DF289 Drug: DF277 Drug: DF289 plus DF277	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections

U.S. FDA Resources

Further study details as provided by Salvat:

Primary Outcome Measures:

Time to Cessation of Otorrhea [ Time Frame: From baseline until the end of the study ( up to 22 days) ] [ Designated as safety issue: No ]


Enrollment:	331
Study Start Date:	June 2011
Study Completion Date:	June 2014
Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: DF289 Ear drops	Drug: DF289 Ear drops
Active Comparator: DF277 Ear drops	Drug: DF277 Ear drops
Experimental: DF289 plus DF277 Ear drops	Drug: DF289 plus DF277 Ear drops

Eligibility


Ages Eligible for Study:	6 Months to 12 Years (Child)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01395966

Locations


Spain
Laboratorios Salvat, S.A.
Esplugues de Llobregat, Barcelona, Spain, 08950

Sponsors and Collaborators

Salvat

More Information


Responsible Party:	Salvat
ClinicalTrials.gov Identifier:	NCT01395966 History of Changes
Other Study ID Numbers:	DF289III/10IA02
Study First Received:	July 8, 2011
Results First Received:	July 22, 2015
Last Updated:	September 22, 2015
Health Authority:	United States: Food and Drug Administration Spain: Agencia Española de Medicamentos y Productos Sanitarios Finland: Finnish Medicines Agency Sweden: Medical Products Agency South Africa: Medicines Control Council Czech Republic: State Institute for Drug Control Denmark: Danish Medicines Agency

Keywords provided by Salvat:


with tubes

Additional relevant MeSH terms:


Otitis Media Otitis Ear Diseases Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 30, 2016

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