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A Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases

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: NCT00360464
Recruitment Status : Completed
First Posted : August 4, 2006
Last Update Posted : April 21, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 3, 2006
First Posted Date  ICMJE August 4, 2006
Last Update Posted Date April 21, 2011
Study Start Date  ICMJE October 2006
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 23, 2007)
The primary endpoint is investigator's clinical efficacy at Day 8.
Original Primary Outcome Measures  ICMJE
 (submitted: August 3, 2006)
The primary endpoint is Investigator's Clinical efficacy at Day 8.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 13, 2008)
Endpoints of efficacy are as follows: Investigator's clinical efficacy (at Day 15 and 29), and the tendency toward clinical improvement (at Day 4); Bacteriological efficacy (at Day 4, 8, 15 and 29); Safety Endpoints: Adverse events and safety lab data.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2006)
  • Endpoints of efficacy are as follows:
  • Investigator's clinical efficacy (at Day 15 and 29), and the tendency toward clinical improvement (at Day 4)
  • Bacteriological efficacy (at Day 4, 8, 15 and 29)
  • Safety Endpoints: Adverse events and safety Laboratory data
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases
Official Title  ICMJE A Multicenter, Non-Randomized, Open Label Trial Of Azithromycin SR For The Treatment Of Acute Bronchitis And Secondary Infection Of Chronic Respiratory Diseases In Japan Adults
Brief Summary To evaluate the clinical efficacy and safety in patients with Acute Bronchitis or Secondary Infection of Chronic Respiratory Diseases receiving a dose of 2 g of azithromycin in the SR formulation.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Bronchitis
Intervention  ICMJE Drug: Azithromycin SR
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 13, 2008)
64
Original Enrollment  ICMJE
 (submitted: August 3, 2006)
60
Actual Study Completion Date  ICMJE June 2007
Actual Primary Completion Date June 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients who were diagnosed as mild or moderate in severity by the classification of infection of the Japanese Society of Chemotherapy guidelines for the evaluation methods of new antibacterial drug (established in 1997).

Exclusion Criteria:

  • Severe underlying disease; patients in which drug clinical evaluation is difficult because of confounding diseases.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00360464
Other Study ID Numbers  ICMJE A0661175
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP