Efficacy and safety of Dexa-Polyspectran® drops, preserved with benzalkonium chloride, vs. Dexa-Polyspectran® drops without dexamethasone phosphate, preserved with benzalkonium chloride, in patients with acute bacterial otitis externa – A double-blind, multicenter, prospective, randomized, controlled clinical phase III study.
- Conditions
- acute bacterial otitis externa
- Registration Number
- EUCTR2005-001179-36-DE
- Lead Sponsor
- Alcon Pharma GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 240
male or female patients from the age of 18 years up to the age of 75 years, unilateral bacterial otitis externa, signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
anamnestically known viral, fungal or tubercular ear infection, otitis media, mastoiditis, mastoid cavities, stenosing exostosis, cholesteatoma, perforated tympanic membrane, invasive malignant chronic otitis externa, pre-treatment of the current otitis externa with local/systemic antibiotics or corticoids, possible use of other analgetics than paracetamol as pain medication during the study, need of antibiotic or corticoid local otic/systemic treatment during the study (other than study drug), vaccination reactions, known diabetes, immunosuppressants, nonsteroidal anti-inflammatory drugs (NSAID), known intolerance / hypersensitivity to ingredients of the study drugs or paracetamol, pregnancy, lactation; no adequate contraceptive protection
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method