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Zithromax-SR 2g, Special Investigation (Regulatory Post Marketing Commitment Plan)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00998309
First received: October 16, 2009
Last updated: April 2, 2012
Last verified: April 2012
History of Changes
Results First Received: January 12, 2012  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Bacterial Infections
Intervention: Drug: Azithromycin SR

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
This was a phase 4, observational, open-label study conducted in participants who were prescribed azithromycin by their treating physician per usual clinical practice. Study drug was not provided by the Sponsor.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Azithromycin SR Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.

Participant Flow:   Overall Study
    Azithromycin SR  
STARTED     502  
COMPLETED     498  
NOT COMPLETED     4  
Protocol Violation                 4  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Azithromycin SR Azithromycin SR should be orally taken as a single dose of 2 g with an empty stomach according to Japanese Package Insert.

Baseline Measures
    Azithromycin SR  
Number of Participants  
[units: participants]
 		  498  
Age, Customized  
[units: years]
Mean (Standard Deviation) 		  39.9  (15.6)  
Gender  
[units: participants]
 		 
Female     211  
Male     287  
Type of Infection [1]
[units: participants]
 		 
Skin and Soft Tissue Infection     104  
Sexual Transmitted Infection     199  
Dental and Oral Surgery Infection     183  
Others     12  
[1] The physician in charge of the survey made the diagnosis of type of infection based on symptoms.



  Outcome Measures
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1.  Primary:   Number of Participants With an Investigator’s Assessment of Clinical Outcome (Effective (Cured)/ Not Effective (Not Cured)) at End of the Study.   [ Time Frame: Baseline to 29 days ]
  Show Outcome Measure 1

2.  Primary:   Number of Participants With Treatment Related Adverse Events (TRAEs)   [ Time Frame: Baseline to 29 days ]
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3.  Primary:   Number of Unlisted Treatment Related Adverse Events (TRAEs)   [ Time Frame: Baseline to 29 days ]
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4.  Secondary:   Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Gender   [ Time Frame: Baseline to 29 days ]
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5.  Secondary:   Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Age   [ Time Frame: Baseline to 29 days ]
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6.  Secondary:   Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Type of Infection   [ Time Frame: Baseline to 29 days ]
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7.  Secondary:   Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Infection Severity   [ Time Frame: Baseline to 29 days ]
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8.  Secondary:   Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Hepatic Dysfunction(HD)   [ Time Frame: Baseline to 29 days ]
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9.  Secondary:   Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Renal Dysfunction(RD)   [ Time Frame: Baseline to 29 days ]
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10.  Secondary:   Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Past Medical History (PMH)   [ Time Frame: Baseline to 29 days ]
  Show Outcome Measure 10

11.  Secondary:   Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Complications   [ Time Frame: Baseline to 29 days ]
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12.  Secondary:   Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Previous Antibiotic Treatment History (PATH)   [ Time Frame: Baseline to 29 days ]
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13.  Secondary:   Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Comcomittant Drugs(CD)   [ Time Frame: Baseline to 29 days ]
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14.  Secondary:   Risk Factors for the Proportion of Responders of Azithromycin (Clinical Effect)-Non-Drug Therapy   [ Time Frame: Baseline to 29 days ]
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15.  Secondary:   Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Gender   [ Time Frame: Baseline to 29 days ]
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16.  Secondary:   Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Age   [ Time Frame: Baseline to 29 days ]
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17.  Secondary:   Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Type of Infection   [ Time Frame: Baseline to 29 days ]
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18.  Secondary:   Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Infection Severity   [ Time Frame: Baseline to 29 days ]
  Show Outcome Measure 18

19.  Secondary:   Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Hepatic Dysfunction   [ Time Frame: Baseline to 29 days ]
  Show Outcome Measure 19

20.  Secondary:   Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Renal Dysfunction   [ Time Frame: Baseline to 29 days ]
  Show Outcome Measure 20

21.  Secondary:   Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Past Medical History   [ Time Frame: Baseline to 29 days ]
  Show Outcome Measure 21

22.  Secondary:   Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Complications   [ Time Frame: Baseline to 29 days ]
  Show Outcome Measure 22

23.  Secondary:   Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Previous Antibiotic Treatment History (PATH)   [ Time Frame: Baseline to 29 days ]
  Show Outcome Measure 23

24.  Secondary:   Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Comcomittant Drugs   [ Time Frame: Baseline to 29 days ]
  Show Outcome Measure 24

25.  Secondary:   Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Non-Drug Therapy   [ Time Frame: Baseline to 29 days ]
  Show Outcome Measure 25

26.  Secondary:   Risk Factors for Incidence Rate of Treatment Related Adverse Events (TRAEs) of Azithromycin -Pregnancy in Female   [ Time Frame: Baseline to 29 days ]
  Show Outcome Measure 26


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
phone: 1-800-718-1021
e-mail: ClinicalTrials.gov_Inquiries@pfizer.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00998309     History of Changes
Other Study ID Numbers: A0661202
Study First Received: October 16, 2009
Results First Received: January 12, 2012
Last Updated: April 2, 2012
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency (PMDA)