NCT03196973

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
493

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 16, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 23, 2017

Completed
29 days until next milestone

Study Start

First participant enrolled

July 22, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 14, 2018

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

April 9, 2021

Completed
Last Updated

April 9, 2021

Status Verified

November 1, 2020

Enrollment Period

1.1 years

First QC Date

June 16, 2017

Results QC Date

November 17, 2020

Last Update Submit

March 16, 2021

Conditions

Acute Otitis Externa

Outcome Measures

Primary Outcomes (1)

  • 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

    End of Treatment (Day 8+2)

Secondary Outcomes (1)

  • Time to End of Pain

    From baseline to End of Study (Day 15+2)

Study Arms (3)

DF289 plus DF277

EXPERIMENTAL

Otic solution

Drug: DF289 plus DF277

DF289

ACTIVE COMPARATOR

Otic solution

Drug: DF289

DF277

ACTIVE COMPARATOR

Otic solution

Drug: DF277

Interventions

DF289 plus DF277DRUG

1 vial into the affected ear twice daily for 7 days

Also known as: Antibiotic and Corticosteroid
DF289 plus DF277
DF289DRUG

1 vial into the affected ear twice daily for 7 days

Also known as: Antibiotic
DF289
DF277DRUG

1 vial into the affected ear twice daily for 7 days

Also known as: Corticosteroid
DF277

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratorios SALVAT

Esplugues de Llobregat, Spain

Location

Related Publications (1)

  • 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.

    PMID: 35834251DERIVED

MeSH Terms

Interventions

Anti-Bacterial AgentsAdrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and UsesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Medical Director
Organization
Laboratorios Salvat, S.A.
ejimenez@svt.com
933946400

Study Officials

  • Enrique Jiménez

    Salvat

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2017

First Posted

June 23, 2017

Study Start

July 22, 2017

Primary Completion

August 31, 2018

Study Completion

September 14, 2018

Last Updated

April 9, 2021

Results First Posted

April 9, 2021

Record last verified: 2020-11

Locations

ES(1)