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NCT01404611 Clinical Trial

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

Acute Otitis Media Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01404611
Other study ID # DF289III/10IA04
Secondary ID
Status Completed
Phase Phase 3
First received July 22, 2011
Last updated October 3, 2017
Start date June 2011
Est. completion date June 2013

Study information
Verified date October 2015
Source Salvat
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 331
Est. completion date June 2013
Est. primary completion date May 2013
Accepts healthy volunteers No
Gender All
Age group 6 Months to 12 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• DF289
Ear drops
• DF277
Ear drops
• DF289 plus DF277
Ear drops

Locations
Country Name City State
Spain Laboratorios SALVAT S.A. Esplugues de Llobregat Barcelona

Sponsors (1)
Lead Sponsor Collaborator
Salvat

Country where clinical trial is conducted

Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to Cessation of Otorrhea From baseline until the end of the study (up to 22 days)
See also
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Terminated NCT05651633 - Analgesic Ear Drops for Children With Acute Otitis Media Phase 3
Completed NCT01941381 - Does Tympanometry Predict Antibiotic Usage in Acute Otitis Media?
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