The Effect of Doxycycline on Matrix Metalloproteinase Exp... | NCT00538967

Studies
The Effect of Doxycycline on Matrix Metalloproteinase Expression and Activity in the Abdominal Aneurysm

NCT00538967

Sponsor

Leiden University Medical Center

Status

Completed

Last Update Posted

Oct 3, 2007Estimated

Enrollment

60Actual

Phase

Phase 2

Conditions

Aortic Aneurysm, Abdominal

Interventions

doxycycline

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Not provided

Completion Date

Aug 2005Actual

First Submitted Date

Oct 2, 2007

First Submission Date that Met QC Criteria

Oct 2, 2007

First Posted Date

Oct 3, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 2, 2007

Last Update Posted Date

Oct 3, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	No Intervention
2	Active Comparator	doxycycline 50 mg/day	Drug: doxycycline
3	Active Comparator	doxycycline 100 mg	Drug: doxycycline
4	Active Comparator	doxycycline 300 mg	Drug: doxycycline

Interventions

Name	Type	Description	Arm Group Labels	Other Names
doxycycline	Drug	2 weeks once daily	2 3 4

Measure	Description	Time Frame
Collagenase mRNA and protein expression		2 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Elective open aneurysm repair

Exclusion Criteria:

Severe kidney and liver dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan HN Lindeman, MD, PhD	Leiden University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Leiden University Medical Center		Leiden		2300RC	Netherlands

Condition Browse Module

MeSH Terms

ID	Term
D017544	Aortic Aneurysm, Abdominal
D000783	Aneurysm

Ancestor Terms

ID	Term
D001014	Aortic Aneurysm
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D001018	Aortic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004318	Doxycycline

Ancestor Terms

ID	Term
D013754	Tetracyclines
D009279	Naphthacenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic

Browse Leaves

Not provided

Browse Branches

Not provided