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.

Phase 1

• Conditions: Acute Otitis Media with Tympanostomy Tubes (AOMT) in Pediatric Patients; MedDRA version: 14.0Level: PTClassification code 10033079Term: Otitis media acuteSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09]

• Registration Number: EUCTR2010-023239-40-ES
• Lead Sponsor: aboratorios SALVAT, S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-09-15
• Study Completion: 2013-05-29
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 331

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified