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Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects

This study has been completed.
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00575094
First received: December 13, 2007
Last updated: June 2, 2011
Last verified: June 2011
History of Changes
Results First Received: March 31, 2009  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Community-Acquired Infections
Intervention: Drug: tigecycline

  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
Subjects were recruited in Japan from November 2007 to February 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects were screened up to 24 hours.

Reporting Groups
  Description
Tigecycline Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.

Participant Flow:   Overall Study
    Tigecycline  
STARTED     9  
COMPLETED     6  
NOT COMPLETED     3  
Adverse Event                 2  
Withdrawal by Subject                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Tigecycline Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.

Baseline Measures
    Tigecycline  
Number of Participants  
[units: participants]
 		  9  
Age  
[units: years]
Mean ± Standard Deviation 		  62.78  ± 18.27  
Gender  
[units: participants]
 		 
Female     3  
Male     6  



  Outcome Measures

1.  Primary:   Number of Patients by Clinical Response at Test-of-Cure (TOC) Visit.   [ Time Frame: 8 weeks ]
  Show Outcome Measure 1


  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: U. S. Contact Center
Organization: Wyeth
e-mail: clintrialresults@wyeth.com


No publications provided


Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00575094     History of Changes
Other Study ID Numbers: 3074A1-3331
Study First Received: December 13, 2007
Results First Received: March 31, 2009
Last Updated: June 2, 2011
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency