- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00683332
Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)
June 9, 2011 updated by: Pfizer
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)
The purpose of this study is to collect post-marketing information on the safety of Tygacil in Filipino patients.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Three-thousand or 10% of total number of patients given tigecycline will be included in the study
Study Type
Observational
Enrollment (Actual)
621
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Manila, Philippines
- Pfizer Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All patients who receive one dose of tigecycline
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
A
|
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).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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?"
|
30 days post injection up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2007
Primary Completion (Actual)
May 1, 2010
Study Completion (Actual)
May 1, 2010
Study Registration Dates
First Submitted
May 21, 2008
First Submitted That Met QC Criteria
May 22, 2008
First Posted (Estimate)
May 23, 2008
Study Record Updates
Last Update Posted (Estimate)
July 8, 2011
Last Update Submitted That Met QC Criteria
June 9, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 3074A1-102235
- B1811057
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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