Back to resultsThe Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm
Primary Purpose
Aortic Aneurysm, Abdominal
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
doxycycline
Sponsored by
About this trial
This is an interventional basic science trial for Aortic Aneurysm, Abdominal focused on measuring Collagenases, MMP, Cathepsins, Doxycycline, Aneurysm
Eligibility Criteria
Inclusion Criteria:
- Elective open aneurysm repair
Exclusion Criteria:
- Severe kidney and liver dysfunction
Sites / Locations
- Leiden University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
No Intervention
Active Comparator
Active Comparator
Active Comparator
Arm Label
1
2
3
4
Arm Description
doxycycline 50 mg/day
doxycycline 100 mg
doxycycline 300 mg
Outcomes
Primary Outcome Measures
Collagenase mRNA and protein expression
Secondary Outcome Measures
Full Information
NCT ID
NCT00538967
First Posted
October 2, 2007
Last Updated
October 2, 2007
Sponsor
Leiden University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00538967
Brief Title
The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm
Official Title
The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
May 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Leiden University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aortic Aneurysm, Abdominal
Keywords
Collagenases, MMP, Cathepsins, Doxycycline, Aneurysm
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
No Intervention
Arm Title
2
Arm Type
Active Comparator
Arm Description
doxycycline 50 mg/day
Arm Title
3
Arm Type
Active Comparator
Arm Description
doxycycline 100 mg
Arm Title
4
Arm Type
Active Comparator
Arm Description
doxycycline 300 mg
Intervention Type
Drug
Intervention Name(s)
doxycycline
Intervention Description
2 weeks once daily
Primary Outcome Measure Information:
Title
Collagenase mRNA and protein expression
Time Frame
2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Elective open aneurysm repair
Exclusion Criteria:
Severe kidney and liver dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan HN Lindeman, MD, PhD
Organizational Affiliation
Leiden University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Leiden University Medical Center
City
Leiden
ZIP/Postal Code
2300RC
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm
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