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

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ClinicalTrials.gov Identifier: NCT01395966
Recruitment Status : Completed
First Posted : July 18, 2011
Results First Posted : October 22, 2015
Last Update Posted : October 22, 2015
Sponsor:
Information provided by (Responsible Party):
Salvat

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

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: Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Study Start Date : June 2011
Actual Primary Completion Date : June 2014
Actual Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

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

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



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


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

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): NCT01395966


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Salvat
ClinicalTrials.gov Identifier: NCT01395966     History of Changes
Other Study ID Numbers: DF289III/10IA02
First Posted: July 18, 2011    Key Record Dates
Results First Posted: October 22, 2015
Last Update Posted: October 22, 2015
Last Verified: September 2015

Keywords provided by Salvat:
with tubes

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