Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
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ClinicalTrials.gov Identifier: NCT01395966 |
Recruitment Status
:
Completed
First Posted
: July 18, 2011
Results First Posted
: October 22, 2015
Last Update Posted
: October 22, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Otitis Media | Drug: DF289 Drug: DF277 Drug: DF289 plus DF277 | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 331 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, 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 |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | June 2014 |
Actual Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
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
|
- Time to Cessation of Otorrhea [ Time Frame: From baseline until the end of the study ( up to 22 days) ]

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Ages Eligible for Study: | 6 Months to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01395966
Spain | |
Laboratorios Salvat, S.A. | |
Esplugues de Llobregat, Barcelona, Spain, 08950 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Salvat |
ClinicalTrials.gov Identifier: | NCT01395966 History of Changes |
Other Study ID Numbers: |
DF289III/10IA02 |
First Posted: | July 18, 2011 Key Record Dates |
Results First Posted: | October 22, 2015 |
Last Update Posted: | October 22, 2015 |
Last Verified: | September 2015 |
Keywords provided by Salvat:
with tubes |
Additional relevant MeSH terms:
Otitis Media Otitis Ear Diseases Otorhinolaryngologic Diseases |