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 2, 2014
Last verified: September 2014
  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:


Further study details as provided by Salvat:

Primary Outcome Measures:
  • Time to cessation of otorrhea [ Time Frame: 3 weeks ] [ 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
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

No publications provided

Responsible Party: Salvat
ClinicalTrials.gov Identifier: NCT01395966     History of Changes
Other Study ID Numbers: DF289III/10IA02
Study First Received: July 8, 2011
Last Updated: September 2, 2014
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 October 01, 2014