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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01404611
Recruitment Status : Completed
First Posted : July 28, 2011
Results First Posted : November 23, 2015
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Acute Otitis Media Drug: DF289 Drug: DF277 Drug: DF289 plus DF277 Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 331 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Media With Tympanostomy Tubes (AOMT) in Pediatric Patients
Study Start Date : June 2011
Primary Completion Date : May 2013
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Time to Cessation of Otorrhea [ Time Frame: From baseline until the end of the study (up to 22 days) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01404611


Locations
Spain
Laboratorios SALVAT S.A.
Esplugues de Llobregat, Barcelona, Spain, 08950
Sponsors and Collaborators
Salvat
More Information

Responsible Party: Salvat
ClinicalTrials.gov Identifier: NCT01404611     History of Changes
Other Study ID Numbers: DF289III/10IA04
First Posted: July 28, 2011    Key Record Dates
Results First Posted: November 23, 2015
Last Update Posted: October 4, 2017
Last Verified: October 2015

Keywords provided by Salvat:
with tubes

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases