NCT01404611

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 middle ear infections in children with ear tubes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
331

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2011

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

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2011

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

November 23, 2015

Completed
Last Updated

October 4, 2017

Status Verified

October 1, 2015

Enrollment Period

1.9 years

First QC Date

July 22, 2011

Results QC Date

July 23, 2015

Last Update Submit

October 3, 2017

Conditions

Acute Otitis Media

Keywords

with tubes

Outcome Measures

Primary Outcomes (1)

  • Time to Cessation of Otorrhea

    From baseline until the end of the study (up to 22 days)

Study Arms (3)

DF289

ACTIVE COMPARATOR

Ear drops

Drug: DF289

DF277

ACTIVE COMPARATOR

Ear drops

Drug: DF277

DF289 plus DF277

EXPERIMENTAL

Ear drops

Drug: DF289 plus DF277

Interventions

DF289DRUG

Ear drops

DF289
DF277DRUG

Ear drops

DF277
DF289 plus DF277DRUG

Ear drops

DF289 plus DF277

Eligibility Criteria

Age6 Months - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • months to 12 years
  • ear tube in the ear which will be treated
  • otorrhea for 3 weeks or less
  • moderate or severe otorrhea

You may not qualify if:

  • other ear diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratorios SALVAT S.A.

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Related Publications (1)

  • Spektor Z, Pumarola F, Ismail K, Lanier B, Hussain I, Ansley J, Butehorn HF 3rd, Esterhuizen K, Byers J, Douglis F, Lansford B, Hernandez FJ. Efficacy and Safety of Ciprofloxacin Plus Fluocinolone in Otitis Media With Tympanostomy Tubes in Pediatric Patients: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2017 Apr 1;143(4):341-349. doi: 10.1001/jamaoto.2016.3537.

    PMID: 28006041DERIVED

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
Enrique Jimenez, Medical Director
Organization
Laboratorios SALVAT
ejimenezv@salvatbiotech.com
+34933946470

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

July 22, 2011

First Posted

July 28, 2011

Study Start

June 1, 2011

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

October 4, 2017

Results First Posted

November 23, 2015

Record last verified: 2015-10

Locations

ES(1)