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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 is currently recruiting participants.
Verified July 2012 by Salvat
Sponsor:
Information provided by (Responsible Party):
Salvat
ClinicalTrials.gov Identifier:
NCT01404611
First received: July 22, 2011
Last updated: July 13, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

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 to end of treatment (one week) ] [ Designated as safety issue: No ]

Estimated Enrollment: 355
Study Start Date: June 2011
Estimated Primary Completion Date: December 2012 (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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 6 months to 2 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01404611

Contacts
Contact: Xavier Cabarrocas, MD +34933946400 ext 6470 clinicaltrials@salvatbiotech.com

Locations
Spain
Laboratorios SALVAT S.A. Recruiting
Esplugues de Llobregat, Barcelona, Spain, 08950
Contact: Xavier Cabarrocas, MD     +34933946400 ext 6470     clinicaltrials@salvatbiotech.com    
Sponsors and Collaborators
Salvat
  More Information

No publications provided

Responsible Party: Salvat
ClinicalTrials.gov Identifier: NCT01404611     History of Changes
Other Study ID Numbers: DF289III/10IA04
Study First Received: July 22, 2011
Last Updated: July 13, 2012
Health Authority: United States: Food and Drug Administration
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Finland: Finnish Medicines Agency
Denmark: Danish Medicines Agency
Czech Republic: State Institute for Drug Control
South Africa: Medicines Control Council

Keywords provided by Salvat:
with tubes

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

ClinicalTrials.gov processed this record on May 16, 2013