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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

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Prospective
Conditions Complicated Skin and Skin Structure Infections
Complicated Intra-abdominal Infections
Intervention Drug: Tigecycline (Tygacil)
Enrollment 621
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tygacil 50 mg
Hide Arm/Group Description Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
Period Title: Overall Study
Started 621
Completed 621
Not Completed 0
Arm/Group Title Tygacil 50 mg
Hide Arm/Group Description Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
Overall Number of Baseline Participants 621
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 621 participants
55.7  (17.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 621 participants
Female
254
  40.9%
Male
367
  59.1%
1.Primary Outcome
Title Number of Participants With Spontaneous Adverse Events
Hide Description 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?"
Time Frame 30 days post injection up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety Population: All participants who received at least 1 dose of tygacil
Arm/Group Title Tygacil 50 mg
Hide Arm/Group Description:
Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
Overall Number of Participants Analyzed 621
Measure Type: Number
Unit of Measure: Participants
17
Time Frame 30 days post injection up to 3 years
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title Tygacil 50 mg
Hide Arm/Group Description Filipino participants received at least 1 intravenous (IV) dose of tygacil 50 mg administered per registered indication as stated in the product label/insert
All-Cause Mortality
Tygacil 50 mg
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tygacil 50 mg
Affected / at Risk (%)
Total   5/621 (0.81%) 
Cardiac disorders   
Cardiopulmonary Arrest  1  4/621 (0.64%) 
Renal and urinary disorders   
Haematuria  1  1/621 (0.16%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tygacil 50 mg
Affected / at Risk (%)
Total   12/621 (1.93%) 
Blood and lymphatic system disorders   
Eosinophilia  1  1/621 (0.16%) 
Gastrointestinal disorders   
Nausea  1  1/621 (0.16%) 
Vomiting  1  5/621 (0.81%) 
Diarrhoea  1  1/621 (0.16%) 
Investigations   
Alanine Aminotransferase Increased  1  1/621 (0.16%) 
Musculoskeletal and connective tissue disorders   
Arthralgia  1  1/621 (0.16%) 
Skin and subcutaneous tissue disorders   
Rash maculo-papular  1  1/621 (0.16%) 
Vascular disorders   
Phlebitis  1  2/621 (0.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 9.1
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc
ClinicalTrials.gov Identifier: NCT00683332     History of Changes
Other Study ID Numbers: 3074A1-102235
B1811057
First Submitted: May 21, 2008
First Posted: May 23, 2008
Results First Submitted: May 2, 2011
Results First Posted: July 8, 2011
Last Update Posted: July 8, 2011