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Treatment of Patients With Acute Sinusitis

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00930488
First received: June 29, 2009
Last updated: November 19, 2012
Last verified: November 2012
History of Changes
  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.


Condition Intervention
Acute Bacterial Sinusitis
 Drug: Avelox (Moxifloxacin, BAY12-8039)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Treatment of Patients With Acute Sinusitis in Daily Practice

Resource links provided by NLM:

MedlinePlus related topics: Sinusitis
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 [ Time 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). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of tolerability and safety of Avalox® in daily practice were investigated. [ Time Frame: Evaluation of therapy outcome at last follow-up visit at end of therapy (approximately after 7 days). ] [ Designated as safety issue: Yes ]
  • Patient characteristics in acute bacterial sinusitis [ Time Frame: Documentation at baseline visit. ] [ Designated as safety issue: No ]
  • History and frequency of sinusitis episodes [ Time Frame: Documentation at baseline visit. ] [ Designated as safety issue: No ]
  • Diagnostic procedures and therapeutic options chosen by physicians in daily practice [ Time Frame: Documentation at baseline visit. ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

n.a.


Enrollment: 6777
Study Start Date: March 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Avelox (Moxifloxacin, BAY12-8039)
Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a diagnosis of acute bacterial sinusitis who take moxifloxacin

Criteria

Inclusion Criteria:

  • Any patient with a diagnosis of acute bacterial sinusitis treated with Avelox® - in accordance with the local production information.

Exclusion Criteria:

  • Those specified in the local product information - contraindications and precautions must be considered.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930488

  Show 19 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Global Medical Affairs Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00930488     History of Changes
Other Study ID Numbers: 12803, TOPAS, AX 0601, 12867 - AX0601AT, 12868 - AX0601PK, 12869 - AX0601EG, 12870 - AX0601NL, 12973 - AX0601SK, 12974 - AX0601SG, 13026 - AX0601ID, 13046 - AX0601PH, 13111 - AX0601RO, 13065 - AX0601CN, 13207 - AX0601FR, 13166 - AX0601MY
Study First Received: June 29, 2009
Last Updated: November 19, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Austria: Ministry of Health
Pakistan: Ministry of Health
Pakistan: Research Ethics Committee
Netherlands: Medical Ethics Review Committee (METC)
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Indonesia: National Agency of Drug and Food Control
Philippines: Department of Health
China: Ethics Committee
China: Ministry of Health
China: National Natural Science Foundation
China: Food and Drug Administration
Romania: Ethics Committee
Malaysia: Ministry of Health
France: French Data Protection Authority
Jordan: Ethical Committee
Lebanon: Institutional Review Board
Lebanon: Ministry of Public Health
Saudi Arabia: Ministry of Health
Saudi Arabia: Research Advisory Council

Keywords provided by Bayer:
Moxifloxacin
MXF
Avelox
Sinusitis
Acute bacterial sinusitis, ABS

Additional relevant MeSH terms:
Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 23, 2013