- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01395966
Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
September 22, 2015 updated by: Salvat
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
331
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Barcelona
-
Esplugues de Llobregat, Barcelona, Spain, 08950
- Laboratorios Salvat, S.A.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 12 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: DF289
Ear drops
|
Ear drops
|
Active Comparator: DF277
Ear drops
|
Ear drops
|
Experimental: DF289 plus DF277
Ear drops
|
Ear drops
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Time to Cessation of Otorrhea
Time Frame: From baseline until the end of the study ( up to 22 days)
|
From baseline until the end of the study ( up to 22 days)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2011
Primary Completion (Actual)
June 1, 2014
Study Completion (Actual)
June 1, 2014
Study Registration Dates
First Submitted
July 8, 2011
First Submitted That Met QC Criteria
July 14, 2011
First Posted (Estimate)
July 18, 2011
Study Record Updates
Last Update Posted (Estimate)
October 22, 2015
Last Update Submitted That Met QC Criteria
September 22, 2015
Last Verified
September 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DF289III/10IA02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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