- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00538967
The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm
October 2, 2007 updated by: Leiden University Medical Center
The matrix metalloproteinase-9 (MMP-9) is considered to play a central role in abdominal aortic aneurysm (AAA) initiation.
Doxycycline has direct MMP-9 inhibiting properties in vitro, and it effectively suppresses AAA development in rodents.
Observed inhibition of AAA progression, and contradictory findings in human studies evaluating the effect of doxycycline therapy on aortic wall MMP-9 suggest that the effects of doxycycline extend beyond MMP-9 inhibition, and that the effect may be dose dependent.
Study Overview
Detailed Description
In this clinical trial, we evaluated the effect of two weeks of low (50 mg/day), medium (100 mg/day) or high dose (300 mg/day) doxycycline versus no medication in patients undergoing elective AAA repair.
The effect of doxycycline treatment on MMP and cysteine proteases, and their respective inhibitors was evaluated in an integrative approach.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
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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Leiden, Netherlands, 2300RC
- Leiden University Medical Center
-
-
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
Description
Inclusion Criteria:
- Elective open aneurysm repair
Exclusion Criteria:
- Severe kidney and liver dysfunction
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
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 1
|
|
Active Comparator: 2
doxycycline 50 mg/day
|
2 weeks once daily
|
Active Comparator: 3
doxycycline 100 mg
|
2 weeks once daily
|
Active Comparator: 4
doxycycline 300 mg
|
2 weeks once daily
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Collagenase mRNA and protein expression
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jan HN Lindeman, MD, PhD, Leiden University Medical Center
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
May 1, 2002
Study Completion (Actual)
August 1, 2005
Study Registration Dates
First Submitted
October 2, 2007
First Submitted That Met QC Criteria
October 2, 2007
First Posted (Estimate)
October 3, 2007
Study Record Updates
Last Update Posted (Estimate)
October 3, 2007
Last Update Submitted That Met QC Criteria
October 2, 2007
Last Verified
October 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P00.146
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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