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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001179-36-DE

Enrollment

240

Registered

2005-07-11

Start date

2005-08-23

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

acute bacterial otitis externa

Interventions

Product Name: Dexa-Polyspectran drops, preserved with benzalkonium chloride Pharmaceutical Form: Ear drops, solution INN or Proposed INN: Dexamethason-21-dihydrogenphosphate disodium salt Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

Measure	Time frame
Primary end point(s): Absolute change of a clinical symptom score from V1 to V2, (redness, swelling, pain, secretion), each assessed by a 4-item scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) ;Secondary Objective: Absolute change of the clinical symptom score from V1-V3, Absolute change of individual scores (for redness, swelling, pain, secretion) from V1-V2, V1-V3, Absolute change of VAS from V1-V2, V1-V3, Amount of pararacetamol 500 mg tablets taken, Patient‘s global assessment of efficacy at V3 ;Main Objective: The objective of this study is to compare the efficacy and safety of both preparations in the treatment of otitis externa and to show a greater benefit of Dexa-Polyspectran preserved with benzalkonium chloride (PN+Dx) compared to Dexa-Polyspectran without dexamethasone phosphate preserved with benzalkonium chloride (PN-Dx) by a stronger reduction of inflammatory otic signs and symptoms.	—

Measure

Time frame

Primary end point(s): Absolute change of a clinical symptom score from V1 to V2, (redness, swelling, pain, secretion), each assessed by a 4-item scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) ;Secondary Objective: Absolute change of the clinical symptom score from V1-V3, Absolute change of individual scores (for redness, swelling, pain, secretion) from V1-V2, V1-V3, Absolute change of VAS from V1-V2, V1-V3, Amount of pararacetamol 500 mg tablets taken, Patient‘s global assessment of efficacy at V3 ;Main Objective: The objective of this study is to compare the efficacy and safety of both preparations in the treatment of otitis externa and to show a greater benefit of Dexa-Polyspectran preserved with benzalkonium chloride (PN+Dx) compared to Dexa-Polyspectran without dexamethasone phosphate preserved with benzalkonium chloride (PN-Dx) by a stronger reduction of inflammatory otic signs and symptoms.

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Countries

Germany

Outcome results

None listed

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