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Prospective, multicenter, randomized, double blind, parallel arm study to evaluate the efficacy and safety of Moxifloxacin 400 mg OD for 7 days versus amoxicillin clavulanate/claritromycin for 10 days in the treatment of Acute Bacterial Rhino Sinusitis

Prospective, multicenter, randomized, double blind, parallel arm study to evaluate the efficacy and safety of Moxifloxacin 400 mg OD for 7 days versus amoxicillin clavulanate/claritromycin for 10 days in the treatment of Acute Bacterial Rhino Sinusitis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-002779-34-IT
Enrollment
400
Registered
2006-03-14
Start date
2005-12-13
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 rhinosinusitis MedDRA version: 6.1 Level: PT Classification code 10001076

Interventions

Trade Name: AVALOX 5CPR 400MG BL PP/AL Pharmaceutical Form: Tablet INN or Proposed INN: Moxifloxacin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Trade Na

Sponsors

BAYER
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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:

Design outcomes

Primary

MeasureTime frame
Main Objective: ;Secondary Objective: ;Primary end point(s):—

Countries

Italy

Outcome results

None listed

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