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Trial record 1 of 1 for:    NCT00683332
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Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)

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: NCT00683332
Recruitment Status : Completed
First Posted : May 23, 2008
Results First Posted : July 8, 2011
Last Update Posted : July 8, 2011
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date May 21, 2008
First Posted Date May 23, 2008
Results First Submitted Date May 2, 2011
Results First Posted Date July 8, 2011
Last Update Posted Date July 8, 2011
Study Start Date April 2007
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 9, 2011)
Number of Participants With Spontaneous Adverse Events [ Time Frame: 30 days post injection up to 3 years ]
Adverse events were based on the signs or symptoms detected during the physical examination and on clinical evaluation of the participant. In addition to the information obtained from these sources, the participant was asked the following nonspecific question: "How have you been feeling since your last visit?"
Original Primary Outcome Measures
 (submitted: May 22, 2008)
Spontaneous Adverse Events will be collected until 30 days after each injection [ Time Frame: 30 days ]
Change History Complete list of historical versions of study NCT00683332 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)
Official Title A Prospective, Observational Study To Monitor Safety In Patients Who Were Administered With Tigecycline (Tygacil) 50 mg By Intravenous Injection (An Observational Study for Safety - Monitored Release)
Brief Summary The purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients.
Detailed Description Three-thousand or 10% of total number of patients given tigecycline will be included in the study
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All patients who receive one dose of tigecycline
Condition
  • Complicated Skin and Skin Structure Infections
  • Complicated Intra-abdominal Infections
Intervention Drug: Tigecycline (Tygacil)
This is a non-interventional study; patients are administered Tygacil as prescribed by their doctor as per registered indications stated in product label/insert (50 mg by Intravenous Injection).
Study Groups/Cohorts A
Intervention: Drug: Tigecycline (Tygacil)
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 Completed
Actual Enrollment
 (submitted: November 10, 2010)
621
Original Estimated Enrollment
 (submitted: May 22, 2008)
500
Actual Study Completion Date May 2010
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients from the study center who received or will receive at least one dose of Tygacil according to the approved product indication.

Exclusion Criteria:

  • Previously discontinued Tygacil therapy due to significant safety concern.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Philippines
Removed Location Countries United States
 
Administrative Information
NCT Number NCT00683332
Other Study ID Numbers 3074A1-102235
B1811057
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date June 2011