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Greatest International Antiinfective Trial With Avelox (GIANT)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00932802
First received: July 2, 2009
Last updated: November 16, 2012
Last verified: November 2012
History of Changes
  Purpose

The observation period for each patient covered an initial treatment period with Avelox® plus optional 2 long-term follow-up periods (6 and 12 months).For each patient, the physician documented data at any initial visit (baseline) and at least one short-term follow-up visit (=initial treatment period).Optionally, long-term follow-ups (6 and 12 months) were documented, and a patient questionnaire was filled in.


Condition Intervention
Bronchitis, Chronic
Bronchial Diseases
 Drug: Moxifloxacin (Avelox, BAY12-8039)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: GIANT - Greatest International Antiinfective Trial With Avelox®

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Evaluation of impact of AECB on the patient and the community as well as effect and safety of a treatment with moxifloxacin tablets in daily life clinical practice [ Time Frame: During documentation at baseline and at at least one short-term follow-up visit; at maximum two short-term (within ca. 14 days) and two long-term follow-up visits (after ca. 6 and 12 months). ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Course of symptom relief [ Time Frame: During documentation of up to two short-term follow-up visits (within ca. 14 days) ] [ Designated as safety issue: No ]
  • Speed of return to normal daily life activities [ Time Frame: During documentation of the last short-term follow-up visit (after ca. 14 days) ] [ Designated as safety issue: No ]
  • Adverse events collection [ Time Frame: Throughout the entire study, whenever Adverse Events occur ] [ Designated as safety issue: Yes ]
  • Evaluation of frequency of new exacerbations [ Time Frame: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months) ] [ Designated as safety issue: No ]
  • Progression of chronic respiratory disease [ Time Frame: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months) ] [ Designated as safety issue: No ]

Enrollment: 50000
Study Start Date: February 2004
Study Completion Date: November 2007
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Moxifloxacin (Avelox, BAY12-8039)
AECB patients under daily life treatment receiving moxifloxacin according to the local product information.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with a diagnosis of AECB who take moxifloxacin

Criteria

Inclusion Criteria:

  • Outpatients with diagnosis of AECB and decision taken by the investigator to prescribe moxifloxacin

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00932802

  Show 24 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

Publications:

Responsible Party: Bayer Schering Pharma AG, Medical Affairs Therapeutic Area Head
ClinicalTrials.gov Identifier: NCT00932802     History of Changes
Other Study ID Numbers: 12219, AX0401, 11828, 12206, 12214, 12234, 12213, 12212, 12216, 12220, 12219, 12217, 12225, 12223, 12229, 12221, 12218, 12222, 12230, 12211, 12227, 12228, 12226, 12235, 12233, 12224, 12215, 12231, 12232
Study First Received: July 2, 2009
Last Updated: November 16, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Non-Interventional
Observational
NIS
Moxifloxacin
 MXF
Avelox
AECB

Additional relevant MeSH terms:
Bronchial Diseases
Bronchitis
Bronchitis, Chronic
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pulmonary Disease, Chronic Obstructive
Moxifloxacin
Anti-Infective Agents
 Norgestimate, ethinyl estradiol drug combination
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 19, 2013