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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
Sponsor:
Information provided by (Responsible Party):
Salvat

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acute Otitis Media
Interventions Drug: DF289
Drug: DF277
Drug: DF289 plus DF277
Enrollment 331

Recruitment Details  
Pre-assignment Details  
Arm/Group Title DF289 DF277 DF289 Plus DF277
Hide Arm/Group Description

Ear drops

DF289: Ear drops

Ear drops

DF277: Ear drops

Ear drops

DF289 plus DF277: Ear drops

Period Title: Overall Study
Started 109 110 112
Completed 99 91 104
Not Completed 10 19 8
Arm/Group Title DF289 DF277 DF289 Plus DF277 Total
Hide Arm/Group Description

Ear drops

DF289: Ear drops

Ear drops

DF277: Ear drops

Ear drops

DF289 plus DF277: Ear drops

Total of all reporting groups
Overall Number of Baseline Participants 109 110 112 331
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 110 participants 112 participants 331 participants
<=18 years
109
 100.0%
110
 100.0%
112
 100.0%
331
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 109 participants 110 participants 112 participants 331 participants
3.5  (2.7) 3.5  (2.6) 3.2  (2.5) 3.4  (2.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 109 participants 110 participants 112 participants 331 participants
Female
66
  60.6%
68
  61.8%
64
  57.1%
198
  59.8%
Male
43
  39.4%
42
  38.2%
48
  42.9%
133
  40.2%
1.Primary Outcome
Title Time to Cessation of Otorrhea
Hide Description [Not Specified]
Time Frame From baseline until the end of the study ( up to 22 days)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title DF289 DF277 DF289 Plus DF277
Hide Arm/Group Description:

Ear drops

DF289: Ear drops

Ear drops

DF277: Ear drops

Ear drops

DF289 plus DF277: Ear drops

Overall Number of Participants Analyzed 109 110 112
Median (95% Confidence Interval)
Unit of Measure: days
7.69
(4.78 to 11.44)
22
(7.43 to 22)
3.75
(3.04 to 4.39)
Time Frame During all the study (22 days)
Adverse Event Reporting Description

Only related TEAE are reported. There were 331 patients randomized, but only 327 were dosed. Only dosed patients are considered for the AE Reporting.

One patient was randomized to receive DF277 but began taking DF289 Plus DF277. This patient is included in the safety population under DF289 Plus DF277 treatment.

 
Arm/Group Title DF289 DF277 DF289 Plus DF277
Hide Arm/Group Description

Ear drops

DF289: Ear drops

Ear drops

DF277: Ear drops

Ear drops

DF289 plus DF277: Ear drops

All-Cause Mortality
DF289 DF277 DF289 Plus DF277
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
DF289 DF277 DF289 Plus DF277
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/108 (0.00%)      0/106 (0.00%)      0/113 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DF289 DF277 DF289 Plus DF277
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/108 (3.70%)      9/106 (8.49%)      7/113 (6.19%)    
Ear and labyrinth disorders       
auricular swelling  1  0/108 (0.00%)  0 0/106 (0.00%)  0 1/113 (0.88%)  1
ear pain  1  1/108 (0.93%)  1 2/106 (1.89%)  2 1/113 (0.88%)  1
otorrhoea  1  0/108 (0.00%)  0 0/106 (0.00%)  0 1/113 (0.88%)  1
ear canal erythema  1  0/108 (0.00%)  0 1/106 (0.94%)  1 0/113 (0.00%)  0
ear discomfort  1  1/108 (0.93%)  1 0/106 (0.00%)  0 0/113 (0.00%)  0
ear haemorrahage  1  0/108 (0.00%)  0 1/106 (0.94%)  1 0/113 (0.00%)  0
Infections and infestations       
otitis media  1  1/108 (0.93%)  1 3/106 (2.83%)  3 2/113 (1.77%)  2
otitis media acute  1  1/108 (0.93%)  1 0/106 (0.00%)  0 1/113 (0.88%)  1
ear infection fungal  1  0/108 (0.00%)  0 1/106 (0.94%)  1 0/113 (0.00%)  0
otitis externa  1  1/108 (0.93%)  1 0/106 (0.00%)  0 0/113 (0.00%)  0
rash  1  0/108 (0.00%)  0 1/106 (0.94%)  1 1/113 (0.88%)  1
Skin and subcutaneous tissue disorders       
excessive granulation tissue  1  0/108 (0.00%)  0 1/106 (0.94%)  1 1/113 (0.88%)  1
dermatitis  1  1/108 (0.93%)  1 0/106 (0.00%)  0 0/113 (0.00%)  0
eczema  1  0/108 (0.00%)  0 1/106 (0.94%)  1 0/113 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedRA 13.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor does not object to publication by Institution of the results of the Trial based on information collected or generated by Institution, whether or not the results are favorable to the Sponsor Drug. However, to ensure against inadvertent disclosure of Confidential Information or unprotected Inventions, Institution will provide Sponsor an opportunity to review any proposed publication or other type of disclosure before it is submitted or otherwise disclosed.
Results Point of Contact
Name/Title: Enrique Jimenez, Medical Director
Organization: Laboratorios SALVAT
Phone: +34933946470
Responsible Party: Salvat
ClinicalTrials.gov Identifier: NCT01395966     History of Changes
Other Study ID Numbers: DF289III/10IA02
First Submitted: July 8, 2011
First Posted: July 18, 2011
Results First Submitted: July 22, 2015
Results First Posted: October 22, 2015
Last Update Posted: October 22, 2015