Clinical study to assess the efficacy and safety of Ciprofloxacin plus Fluocinolone otic solution compared to Ciprofloxacin otic solution and to Fluocinolone Otic solution in the treatment of ear infection in pediatric patients with tympanostomy tubes.

A Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% Otic Solution Compared to Ciprofloxacin 0.3% Otic solution and to Fluocinolone Acetonide 0.025% Otic Solution in the Treatment of Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric Patients.

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2010-023239-40-ES

Enrollment

330

Registered

2011-09-15

Start date

2011-07-27

Completion date

Unknown

Last updated

2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric Patients MedDRA version: 14.0 Level: PT Classification code 10033079 Term: Otitis media acute System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: CETRAXAL PLUS, gotas óticas en solución Pharmaceutical Form: Ear drops, solution INN or Proposed INN: FLUOCINOLONE ACETONIDE CAS Number: 67-73-2 Concentration unit: % percent Concentration

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient of either sex between 6 months and 12 years of age (both inclusive) 2. Patients with patent tympanostomy tube in the ear which will be treated (must be present and open) 3. Patients suffering from otorrhea for 3 weeks or less 4. Moderate or severe purulent otorrhea at inclusion 5. Signed informed consent from the patient?s legally authorized representative; also, if the patient is capable of providing assent, signed assent from the patient. Are the trial subjects under 18? yes Number of subjects for this age range: 330 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Tympanostomy tube placement 3 days or less before study entry 2. Tympanostomy tubes containing antiseptic or antibacterial activity (silver oxide or silver salts), T-type tubes 3. Acute otitis externa or malignant otitis externa 4. Suspected viral, fungal, or mycobacterial ear infection 5. Otologic surgery within the previous year (other than tympanostomy tube placement) 6. Mastoiditis 7. Known or suspected quinolone and/or corticoids hypersensitivity 8. History of an immunosuppressive disorder, current immunosuppressive therapy, or diabetes 9. Acute or chronic renal disease, active hepatitis 10. Chronic nasal obstruction and/or persistent rhinorrhea 11. Craniofacial anomalies 12. Patient predisposed to neurosensory hearing loss 13. Use of topical nonsteroidal otic agents within one day of study entry 14. Use of topical or otic steroids within 3 days of enrollment or systemic steroids within 7 days of enrollment 15. Use of intranasal or inhaled steroids within 3 days of enrollment 16. Any infection requiring systemic antimicrobial therapy 17. Use of topical or systemic antimicrobial or antifungal agents within the previous 7 days of study entry or antimicrobial therapy for the current episode of AOMT. 18. Concurrent use of oral anti-inflammatory agents, except ibuprofen (analgesics without anti-inflammatory properties, such as acetaminophen are allowed) 19. Menarcheal female 20. Participation in another clinical trial in the previous 30 days

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the study is to evaluate the efficacy and safety of topical Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% otic solution twice a day for 7 days and the primary endpoint is to demonstrate therapeutic superiority for time to cessation of otorrhea over Ciprofloxacin 0.3% otic solution and over Fluocinolone Acetonide 0.025% otic solution, in patients suffering from AOMT. Otorrhea will be defined as ending on the first day on which the otorrhea is absent and remains absentuntil the end of the study.;Secondary Objective: The principal secondary endpoint is to demonstrate therapeutic superiority of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% over Fluocinolone Acetonide 0.025% alone and Ciprofloxacin 0.3% over Fluocinolone Acetonide 0.025% alone with respect to sustained microbiological cure.;Primary end point(s): To demonstrate superiority of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% otic solution relative to Ciprofloxacin 0.3% otic solution and to Fluocinolone Acetonide 0.025% otic solution with respect to time to cessation of otorrhea. Otorrhea will be defined as ending on the first day on which the otorrhea is absent and remains absent until the end of the study.;Timepoint(s) of evaluation of this end point: Otorrhea will be assessed at Visits 1, 2, 3, and 4 by the investigator	—

Measure

Time frame

Main Objective: The primary objective of the study is to evaluate the efficacy and safety of topical Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% otic solution twice a day for 7 days and the primary endpoint is to demonstrate therapeutic superiority for time to cessation of otorrhea over Ciprofloxacin 0.3% otic solution and over Fluocinolone Acetonide 0.025% otic solution, in patients suffering from AOMT. Otorrhea will be defined as ending on the first day on which the otorrhea is absent and remains absentuntil the end of the study.;Secondary Objective: The principal secondary endpoint is to demonstrate therapeutic superiority of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% over Fluocinolone Acetonide 0.025% alone and Ciprofloxacin 0.3% over Fluocinolone Acetonide 0.025% alone with respect to sustained microbiological cure.;Primary end point(s): To demonstrate superiority of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% otic solution relative to Ciprofloxacin 0.3% otic solution and to Fluocinolone Acetonide 0.025% otic solution with respect to time to cessation of otorrhea. Otorrhea will be defined as ending on the first day on which the otorrhea is absent and remains absent until the end of the study.;Timepoint(s) of evaluation of this end point: Otorrhea will be assessed at Visits 1, 2, 3, and 4 by the investigator

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: The Microbiological cultures of middle ear will be taken at Visits 1, 3 and 4 (except when no exudate is present at Visit 3 or 4).;Secondary end point(s): The principal secondary endpoint is to demonstrate therapeutic superiority of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% otic solution over Fluocinolone Acetonide 0.025% otic solution and Ciprofloxacin 0.3% otic solution over Fluocinolone Acetonide 0.025% otic solution with respect to sustained microbiological cure.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: The Microbiological cultures of middle ear will be taken at Visits 1, 3 and 4 (except when no exudate is present at Visit 3 or 4).;Secondary end point(s): The principal secondary endpoint is to demonstrate therapeutic superiority of Ciprofloxacin 0.3% plus Fluocinolone Acetonide 0.025% otic solution over Fluocinolone Acetonide 0.025% otic solution and Ciprofloxacin 0.3% otic solution over Fluocinolone Acetonide 0.025% otic solution with respect to sustained microbiological cure.

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Countries

Czech Republic, Denmark, Finland, Spain, Sweden, United States

Contacts

Public ContactMedical Department

Laboratorios SALVAT, S.A.

xcabarrocas@salvatbiotech.com+3493 394 64 70

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026