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Greatest International Antiinfective Trial With Avelox (GIANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00932802
Recruitment Status : Completed
First Posted : July 3, 2009
Last Update Posted : November 19, 2012
Sponsor:
Information provided by:
Bayer

Brief Summary:
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 or disease Intervention/treatment
Bronchitis, Chronic Bronchial Diseases Drug: Moxifloxacin (Avelox, BAY12-8039)

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Study Type : Observational
Actual Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: GIANT - Greatest International Antiinfective Trial With Avelox®
Study Start Date : February 2004
Actual Primary Completion Date : November 2007
Actual Study Completion Date : November 2007

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1 Drug: Moxifloxacin (Avelox, BAY12-8039)
AECB patients under daily life treatment receiving moxifloxacin according to the local product information.




Primary Outcome Measures :
  1. 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). ]

Secondary Outcome Measures :
  1. Course of symptom relief [ Time Frame: During documentation of up to two short-term follow-up visits (within ca. 14 days) ]
  2. Speed of return to normal daily life activities [ Time Frame: During documentation of the last short-term follow-up visit (after ca. 14 days) ]
  3. Adverse events collection [ Time Frame: Throughout the entire study, whenever Adverse Events occur ]
  4. 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) ]
  5. Progression of chronic respiratory disease [ Time Frame: During documentation of up to two long-term follow-up visits (after ca. 6 and 12 months) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00932802


Locations
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Austria
Many Locations, Austria
Brazil
Many Locations, Brazil
China
Many Locations, China
Colombia
Many Locations, Colombia
Croatia
Many Locations, Croatia
Egypt
Many Locations, Egypt
El Salvador
Many Locations, El Salvador
Germany
Many Locations, Germany
Hong Kong
Many Locations, Hong Kong
Hungary
Many Locations, Hungary
Indonesia
Many Locations, Indonesia
Korea, Republic of
Many Locations, Korea, Republic of
Malaysia
Many Locations, Malaysia
Mexico
Many Locations, Mexico
Morocco
Many Locations, Morocco
Netherlands
Many Locations, Netherlands
Pakistan
Many Locations, Pakistan
Philippines
Many Locations, Philippines
Poland
Many Locations, Poland
Singapore
Many Locations, Singapore
Slovenia
Many Locations, Slovenia
Switzerland
Many Locations, Switzerland
Taiwan
Many Locations, Taiwan
Turkey
Many Locations, Turkey
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Publications of Results:
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Responsible Party: Bayer Schering Pharma AG, Medical Affairs Therapeutic Area Head
ClinicalTrials.gov Identifier: NCT00932802    
Other Study ID Numbers: 12219
AX0401 ( Other Identifier: Company Internal )
11828 ( Other Identifier: Company Internal )
12206 ( Other Identifier: Company Internal )
12214 ( Other Identifier: Company Internal )
12234 ( Other Identifier: Company Internal )
12213 ( Other Identifier: Company Internal )
12212 ( Other Identifier: Company Internal )
12216 ( Other Identifier: Company Internal )
12220 ( Other Identifier: Company Internal )
12219 ( Other Identifier: Company Internal )
12217 ( Other Identifier: Company Internal )
12225 ( Other Identifier: Company Internal )
12223 ( Other Identifier: Company Internal )
12229 ( Other Identifier: Company Internal )
12221 ( Other Identifier: Company Internal )
12218 ( Other Identifier: Company Internal )
12222 ( Other Identifier: Company Internal )
12230 ( Other Identifier: Company Internal )
12211 ( Other Identifier: Company Internal )
12227 ( Other Identifier: Company Internal )
12228 ( Other Identifier: Company Internal )
12226 ( Other Identifier: Company Internal )
12235 ( Other Identifier: Company Internal )
12233 ( Other Identifier: Company Internal )
12224 ( Other Identifier: Company Internal )
12215 ( Other Identifier: Company Internal )
12231 ( Other Identifier: Company Internal )
12232 ( Other Identifier: Company Internal )
First Posted: July 3, 2009    Key Record Dates
Last Update Posted: November 19, 2012
Last Verified: November 2012
Keywords provided by Bayer:
Non-Interventional
Observational
NIS
Moxifloxacin
MXF
Avelox
AECB
Additional relevant MeSH terms:
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Moxifloxacin
Bronchitis
Bronchial Diseases
Bronchitis, Chronic
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pulmonary Disease, Chronic Obstructive
Norgestimate, ethinyl estradiol drug combination
Anti-Infective Agents
Anti-Bacterial Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs