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Special Drug Use Investigation - Assessment of Efficacy and Safety in Treating Secondary Infection of Chronic Respiratory Disease

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01690533
First received: September 19, 2012
Last updated: NA
Last verified: September 2012
History: No changes posted
  Purpose

The objective of this study is to assess the efficacy and safety of Avelox Tablet 400 mg (hereinafter as "Avelox") in treating secondary infection of chronic respiratory disease.It is a local prospective and observational study of patients who have received Avelox tablets for Laryngopharyngitis, Tonsillitis, Bronchitis acute, Pneumonia, Secondary infection in chronic respiratory diseases, Sinusitis. A total of 500 patients are to be enrolled and assessed during the period of treatment with Avelox.


Condition Intervention
Anti-Infective Agents
 Drug: Avelox (Moxifloxacin, BAY12-8039)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Special Drug Use Investigation - Assessment of Efficacy and Safety in Treating Secondary Infection of Chronic Respiratory Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of adverse drug reactions (ADRs) and serious adverse events (SAEs) [ Time Frame: After 7 days ] [ Designated as safety issue: Yes ]
  • Clinical efficacy rate (Response, Minor Response, No Response and Indeterminable) assessed by investigator's discretion. Efficacy rate is calculated as number of patients with Response or Minor Response proportional to number of all cases. [ Time Frame: After 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ADR incidence rates classified by patient's background factors [ Time Frame: After 7 days ] [ Designated as safety issue: Yes ]
  • Efficacy rates classified by patient's background factors [ Time Frame: After 7 days ] [ Designated as safety issue: No ]

Enrollment: 497
Study Start Date: May 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Avelox (Moxifloxacin, BAY12-8039)
Patients treated with Moxifloxacin in daily clinical practice

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with secondary infection of chronic respiratory disease (excluding acute bronchitis patients who have been determined to be without chronic respiratory tract disease based on their medical history, x-ray findings, and/or other findings)

Criteria

Inclusion Criteria:

  • Patients with secondary infection of chronic respiratory disease (excluding acute bronchitis patients who have been determined to be without chronic respiratory tract disease based on their medical history, x-ray findings, and/or other findings) who meet the following criteria:
  • 20 years old or older
  • with infection of mild or moderate severity
  • Patients who meet the following criteria immediately before starting the therapy: ≥37°C of body temperature, expectoration of purulent or mucopurulent sputum, and either white blood cell count ≥8,000/mm3 or CRP ≥0.7 mg/dL

Exclusion Criteria:

  • Patients who are contraindicated based on the product label.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01690533

Locations
Japan
Many Locations, Japan
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: Medical Director, Bayer Yakuhin, Ltd.
ClinicalTrials.gov Identifier: NCT01690533     History of Changes
Other Study ID Numbers: 16515
Study First Received: September 19, 2012
Last Updated: September 19, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Bayer:
Avelox
Laryngopharyngitis
Tonsillitis
 Bronchitis acute
Pneumonia
Secondary infection in chronic respiratory diseases Sinusitis

Additional relevant MeSH terms:
Respiration Disorders
Respiratory Tract 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 22, 2013