check_circleStudy Completed

Acute Bacterial Sinusitis

Bayer Identifier:

12803

ClinicalTrials.gov Identifier:

NCT00930488

EudraCT Number:

Not Available

EU CT Number:

Not Available
Treatment of patients with acute sinusitis

Trial purpose

For each patient, an initial visit and at least one follow-up visit at the end of treatment should be documented by the treating physician in the case report form.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Any patient with a diagnosis of acute bacterial sinusitis treated with Avelox® - in accordance with the local production information.
  • - Those specified in the local product information - contraindications and precautions must be considered.

Trial summary

Enrollment Goal
6777
Trial Dates
March 2007 - December 2008
Phase
N/A
Could I Receive a placebo
No
Products
Avelox (Moxifloxacin hydrochloride, BAY12-8039)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, United Arab Emirates
Completed
Many Locations, China
Completed
Many Locations, Kuwait
Completed
Many Locations, Lebanon
Completed
Many Locations, Malaysia
Completed
Many Locations, Romania
Completed
Many Locations, Singapore
Completed
Many Locations, Yemen
Completed
Many Locations, Germany
Completed
Many Locations, Austria
Completed
Many Locations, Bahrain
Completed
Many Locations, Egypt
Completed
Many Locations, France
Completed
Many Locations, Indonesia
Completed
Many Locations, Jordan
Completed
Many Locations, Netherlands
Completed
Many Locations, Philippines
Completed
Many Locations, Pakistan
Completed
Many Locations, Saudi Arabia

Primary Outcome

  • Evaluation of potential benefits of an antibacterial therapy with Avelox® (moxifloxacin) in patients with acute bacterial sinusitis to whom this treatment was prescribed. Especially the time to improvement and resolution of clinical signs and symptoms of
    date_rangeTime Frame:
    Documentation at baseline and at at least one follow-up visit. Evaluation of therapy outcome at last follow-up visit at end of therapy (approximately after 7 days).
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    Safety Issue:
    no

Secondary Outcome

  • Evaluation of tolerability and safety of Avalox® in daily practice were investigated.
    date_rangeTime Frame:
    Evaluation of therapy outcome at last follow-up visit at end of therapy (approximately after 7 days).
    enhanced_encryption
    Safety Issue:
    yes
  • Patient characteristics in acute bacterial sinusitis
    date_rangeTime Frame:
    Documentation at baseline visit.
    enhanced_encryption
    Safety Issue:
    no
  • History and frequency of sinusitis episodes
    date_rangeTime Frame:
    Documentation at baseline visit.
    enhanced_encryption
    Safety Issue:
    no
  • Diagnostic procedures and therapeutic options chosen by physicians in daily practice
    date_rangeTime Frame:
    Documentation at baseline visit.
    enhanced_encryption
    Safety Issue:
    no

Trial design

Treatment of patients with acute sinusitis in daily practice
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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