CompletedNCT03196973Updated Apr 9, 2021Results posted

Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa

A Phase 3 interventional study of DF289 plus DF277 and DF289 in Acute Otitis Externa, sponsored by Salvat. Completed at 1 site in Spain. Open to participants aged 6 Months and older. Per ClinicalTrials.gov, last updated 2021-04-09.

Sponsored by Salvat · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 493
Allocation: Randomized
Ages: 6 Months and older
Sex: All

Study summary

The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE

Conditions studied

Acute Otitis Externa

Browse trials for

Who can participate

Ages eligible: 6 Months and older
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Uncomplicated AOE of less tan 21 days, defined as a total symptom score of at least 2 for otalgia, 2 for edema and 1 for otorrhea
Brighton Grading of II or III
Culture-based diagnosis of acute bacterial otitis externa
Willingness to refrain from swimming through end of the study

Exclusion criteria

Exclusion Criteria:

Previous episode of AOE within 4 weeks prior to enrollment, or 2 or more episodes of AOE within 6 months prior to the enrollment.
Tympanic membrane perforation
Any condition or situation likely to cause the patient to be unable or unwilling to comply with study treatment or attend all study visits
Any condition in the patient or parent/guardian that, in the judgment of the principal investigator, could compromise patient safety, limit the patient's ability to complete the study, and/or compromise the objectives of the study

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 493 participants (actual)

Study arms

Experimental
DF289 plus DF277
Otic solution
Drug: DF289 plus DF277
Active comparator
DF289
Otic solution
Drug: DF289
Active comparator
DF277
Otic solution
Drug: DF277

Interventions

DrugDF289 plus DF277
1 vial into the affected ear twice daily for 7 days
Also known as: Antibiotic and Corticosteroid
DrugDF289
1 vial into the affected ear twice daily for 7 days
Also known as: Antibiotic
DrugDF277
1 vial into the affected ear twice daily for 7 days
Also known as: Corticosteroid

What researchers measure

Primary outcomes

Therapeutic Cure (Clinical + Microbiological Cure)
Therapeutic cure will be considered achieved if edema, otalgia and otorrhea are resolved with no further requirement of antimicrobial therapy and bacteriological response is Eradication or Presumed Eradication
Time frame: End of Treatment (Day 8+2)

Secondary outcomes

Time to End of Pain
First day on which there is no use of analgesics, the pain score is zero and remains zero until end of study
Time frame: From baseline to End of Study (Day 15+2)

Results

Posted Apr 9, 2021

Participant flow

Participant flow — Overall Study
Milestone	DF289 Plus DF277	DF289	DF277
Started	197	196	100
Completed	188	184	95
Not completed	9	12	5
Withdrew: Adverse event	1	1	2
Withdrew: Lack of efficacy	2	6	1
Withdrew: Lost to follow-up	4	3	2
Withdrew: Consent withdrawn	2	1	0
Withdrew: Administration of a wrong kit of study medication	0	1	0

Outcome measures

PrimaryTherapeutic Cure (Clinical + Microbiological Cure)

Therapeutic cure will be considered achieved if edema, otalgia and otorrhea are resolved with no further requirement of antimicrobial therapy and bacteriological response is Eradication or Presumed Eradication

Time frame:: End of Treatment (Day 8+2)
Reported as:: Count of participants · Participants

Therapeutic Cure (Clinical + Microbiological Cure)
Participants	DF289 Plus DF277	DF289	DF277
Therapeutic Cure (Clinical + Microbiological Cure)	63	49	20

SecondaryTime to End of Pain

First day on which there is no use of analgesics, the pain score is zero and remains zero until end of study

Time frame:: From baseline to End of Study (Day 15+2)
Reported as:: Median · days

Time to End of Pain
days	DF289 Plus DF277	DF289	DF277
Time to End of Pain	5.0 (4.23 to 6.34)	5.9 (4.26 to 7.25)	7.7 (6.74 to 9.00)

Adverse events

Collected over From study entry to Visit 4(Day 15+2). Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
DF289 Plus DF277	0/196 (0%)	1/196 (0.5%)	11/196 (5.6%)
DF289	0/195 (0%)	0/195 (0%)	12/195 (6.2%)
DF277	0/100 (0%)	0/100 (0%)	4/100 (4%)

Most frequent serious events

Most frequent serious events
Event	DF289 Plus DF277	DF289	DF277
Acute PsychosisPsychiatric disorders	1/196	0/195	0/100

Most frequent other events

Most frequent other events
Event	DF289 Plus DF277	DF289	DF277
headacheNervous system disorders	4/196	6/195	1/100
application site painGeneral disorders	4/196	0/195	0/100
ear painEar and labyrinth disorders	2/196	2/195	0/100
ear pruritusEar and labyrinth disorders	0/196	2/195	0/100
back painMusculoskeletal and connective tissue disorders	0/196	2/195	0/100
dizzinessNervous system disorders	0/196	2/195	0/100
tachycardiaCardiac disorders	1/196	0/195	1/100
cellulitisInfections and infestations	0/196	0/195	1/100
otitis mediaInfections and infestations	0/196	0/195	1/100

Baseline characteristics

CITT Population (Randomized patients)

Age, Categorical
Age, Categorical(Participants)	DF289 Plus DF277	DF289	DF277	Total
<=18 years	57	57	31	145
Between 18 and 65 years	102	115	54	271
>=65 years	38	24	15	77

Age, Continuous
Age, Continuous(years)	DF289 Plus DF277	DF289	DF277	Total
Mean	37.8 ± 23.81	38.4 ± 22.64	38.7 ± 22.79	38.2 ± 23.10

Sex: Female, Male
Sex: Female, Male(Participants)	DF289 Plus DF277	DF289	DF277	Total
Female	97	101	56	254
Male	100	95	44	239

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	DF289 Plus DF277	DF289	DF277	Total
American Indian or Alaska Native	1	2	0	3
Asian	0	1	2	3
Native Hawaiian or Other Pacific Islander	0	0	0	0
Black or African American	29	30	15	74
White	162	161	82	405
More than one race	1	0	0	1
Unknown or Not Reported	4	2	1	7

Region of Enrollment
Region of Enrollment(participants)	DF289 Plus DF277	DF289	DF277	Total
United States	197	196	100	493

Study locations

1 site

Laboratorios SALVAT
Esplugues de Llobregat, Spain

References and documents

Publications

Chu L, Acosta AM, Aazami H, Dennis P, De Valle O, Ehmer D Jr, Hedrick JA, Ansley JF. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Among Patients With Acute Otitis Externa: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2221699. doi: 10.1001/jamanetworkopen.2022.21699. PubMed 35834251 ↗

Study documents

Study protocol · Feb 26, 2018
Statistical analysis plan · Nov 14, 2018

Documents are hosted by the registry — open the source record to download them.

Registry details

Key details

Study ID: NCT03196973
Lead sponsor: Salvat
Responsible party: Sponsor
First posted: Jun 23, 2017
Start date: Jul 22, 2017
Primary completion: Aug 31, 2018
Completion: Sep 14, 2018
Results posted: Apr 9, 2021
Last update: Apr 9, 2021

Study contacts

Enrique Jiménez

study director · Salvat

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Otitis→

Other studies from this sponsor

Salvat

Start the discussion