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

NCT01395966, Phase 3, Completed, Salvat; results first posted 2015-10-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients. Trials, record NCT01395966. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01395966

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

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
NCT number: NCT01395966
Status: Completed
Phases: Phase 3
Enrollment: 331 participants, actual
Lead sponsor: Salvat
Conditions: Acute Otitis Media
Interventions: DF289, DF277, DF289 plus DF277
First posted: 2011-07-18
Last updated: 2015-10-22
Results first posted: 2015-10-22

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Cessation of Otorrhea	From baseline until the end of the study ( up to 22 days)

Source ClinicalTrials.gov

Outcomes1

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Cessation of Otorrhea	From baseline until the end of the study ( up to 22 days)		days	MEDIAN

Source ClinicalTrials.gov

Results by group3

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Time to Cessation of Otorrhea	DF289	7.69	95% Confidence Interval 4.78 to 11.44	days
Time to Cessation of Otorrhea	DF277	22	95% Confidence Interval 7.43 to 22	days
Time to Cessation of Otorrhea	DF289 Plus DF277	3.75	95% Confidence Interval 3.04 to 4.39	days

Source ClinicalTrials.gov

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	DF289	109
Overall Study	STARTED	DF277	110
Overall Study	STARTED	DF289 Plus DF277	112
Overall Study	COMPLETED	DF289	99
Overall Study	COMPLETED	DF277	91
Overall Study	COMPLETED	DF289 Plus DF277	104
Overall Study	NOT COMPLETED	DF289	10
Overall Study	NOT COMPLETED	DF277	19
Overall Study	NOT COMPLETED	DF289 Plus DF277	8

Source ClinicalTrials.gov

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	auricular swelling	Ear and labyrinth disorders	DF289	0	108	0
other	auricular swelling	Ear and labyrinth disorders	DF277	0	106	0
other	auricular swelling	Ear and labyrinth disorders	DF289 Plus DF277	1	113	1
other	ear pain	Ear and labyrinth disorders	DF289	1	108	1
other	ear pain	Ear and labyrinth disorders	DF277	2	106	2
other	ear pain	Ear and labyrinth disorders	DF289 Plus DF277	1	113	1
other	otorrhoea	Ear and labyrinth disorders	DF289	0	108	0
other	otorrhoea	Ear and labyrinth disorders	DF277	0	106	0
other	otorrhoea	Ear and labyrinth disorders	DF289 Plus DF277	1	113	1
other	ear canal erythema	Ear and labyrinth disorders	DF289	0	108	0

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	DF289
Total, all-cause mortality	DF277
Total, all-cause mortality	DF289 Plus DF277
Total, other adverse events	DF289	4	108
Total, other adverse events	DF277	9	106
Total, other adverse events	DF289 Plus DF277	7	113
Total, serious adverse events	DF289	0	108
Total, serious adverse events	DF277	0	106
Total, serious adverse events	DF289 Plus DF277	0	113

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
28006041	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT01395966

GET https://conductscience.org/api/trials/v1/NCT01395966/events?page=2

API reference For AI assistants