Acute Otitis ExternaPhase 3NCT03196973
Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Acute Otitis Externa
A Phase 3 study testing DF289 plus DF277, DF289 and DF277 in people with Acute Otitis Externa, run by Salvat at 1 site in Spain.
Trial 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 Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- Acute Otitis Externa
- What is being tested?
- DF289 plus DF277, DF289 and DF277
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 493 participants
- Where
- 1 siteSpain
- Study dates
- 22 Jul 2017to 14 Sep 2018
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Externa (AOE)
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
- Acute Otitis Externa
- Being tested
- DF289 plus DF277, DF289, DF277
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DF289 plus DF277Drug
Also called Antibiotic and Corticosteroid
1 vial into the affected ear twice daily for 7 days
DF289Drug
Also called Antibiotic
1 vial into the affected ear twice daily for 7 days
DF277Drug
Also called Corticosteroid
1 vial into the affected ear twice daily for 7 days
| Study group | Role | What they receive |
|---|---|---|
| DF289 plus DF277 | Experimental | Otic solution Receives: Drug: DF289 plus DF277 |
| DF289 | Active comparator | Otic solution Receives: Drug: DF289 |
| DF277 | Active comparator | Otic solution Receives: Drug: DF277 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: End of Treatment (Day 8+2)
Secondary outcomes (1)
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
Measured: From baseline to End of Study (Day 15+2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2017
- Study start22 Jul 2017
- Primary completion31 Aug 2018
- Study completion14 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Otitis ExternaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salvat
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Enrique Jiménez, Study director, Salvat
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03196973
- Sponsor's protocol ID
- DF289OT3-16IA01
- Status last verified
- Nov 2020
- First submitted
- 16 Jun 2017
- Last updated
- 9 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
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 at a glance
From the registry record, last updated by the sponsor on 9 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution Compared to DF289 Otic Solution and to DF277 Otic Solution in the Treatment of Acute Otitis Externa (AOE)
- ClinicalTrials.gov ID
- NCT03196973
- Acronym / sponsor ID
- DF289OT3-16IA01
- Conditions
- Acute Otitis Externa
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- SalvatIndustry (pharma, biotech, devices)
- Study start
- 22 Jul 2017 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 14 Sep 2018 (actual)
- First posted
- 23 Jun 2017 (actual)
- Results
- Posted 9 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if a combination of an antibiotic plus a corticosteroid is safe and effective in treating AOE
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| DF289 plus DF277 | Experimental | Drug: DF289 plus DF277Otic solution |
| DF289 | Active comparator | Drug: DF289Otic solution |
| DF277 | Active comparator | Drug: DF277Otic solution |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DF289 plus DF277Also: Antibiotic and Corticosteroid1 vial into the affected ear twice daily for 7 days | Drug | DF289 plus DF277 |
| DF289Also: Antibiotic1 vial into the affected ear twice daily for 7 days | Drug | DF289 |
| DF277Also: Corticosteroid1 vial into the affected ear twice daily for 7 days | Drug | DF277 |
Primary outcome
Therapeutic Cure (Clinical + Microbiological Cure)
Time frame: End of Treatment (Day 8+2)
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
1 secondary outcome
Time to End of Pain
Time frame: From baseline to End of Study (Day 15+2)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35834251Chu 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.
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Post-COVID-19 Condition, Ulcerative Colitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Enrique Jiménez study director
Salvat
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DF289 plus DF277, DF289 and DF277 in people with Acute Otitis Externa, run by Salvat at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic Cure (Clinical + Microbiological Cure) (time frame: End of Treatment (Day 8+2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03196973, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2021.