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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)
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