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Trial record 26 of 228 for:    special | Japan

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

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ClinicalTrials.gov Identifier: NCT01690533
Recruitment Status : Completed
First Posted : September 21, 2012
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief Summary:
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 or disease Intervention/treatment
Anti-Infective Agents Drug: Avelox (Moxifloxacin, BAY12-8039)

Study Type : Observational
Actual Enrollment : 497 participants
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
Actual Study Start Date : May 13, 2008
Actual Primary Completion Date : December 14, 2010
Actual Study Completion Date : July 19, 2013

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Group 1 Drug: Avelox (Moxifloxacin, BAY12-8039)
Patients treated with Moxifloxacin in daily clinical practice




Primary Outcome Measures :
  1. Number of adverse drug reactions (ADRs) and serious adverse events (SAEs) [ Time Frame: After 7 days ]
  2. 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 ]

Secondary Outcome Measures :
  1. ADR incidence rates classified by patient's background factors [ Time Frame: After 7 days ]
  2. Efficacy rates classified by patient's background factors [ Time Frame: After 7 days ]


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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): NCT01690533


Locations
Japan
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01690533     History of Changes
Other Study ID Numbers: 16515
First Posted: September 21, 2012    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

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

Additional relevant MeSH terms:
Infection
Respiration Disorders
Respiratory Tract Diseases
Coinfection
Virus Diseases
Parasitic Diseases
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective 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