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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:
ClinicalTrials.gov Identifier:
NCT01404611
First Posted: July 28, 2011
Last Update Posted: November 23, 2015
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.
Information provided by (Responsible Party):
Salvat
  Purpose
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 Intervention Phase
Acute Otitis Media Drug: DF289 Drug: DF277 Drug: DF289 plus DF277 Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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) ]

Enrollment: 331
Study Start Date: June 2011
Study Completion Date: June 2013
Primary Completion Date: May 2013 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


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 Submitted: July 22, 2011
First Posted: July 28, 2011
Results First Submitted: July 23, 2015
Results First Posted: November 23, 2015
Last Update Posted: November 23, 2015
Last Verified: October 2015

Keywords provided by Salvat:
with tubes

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


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