Back to resultsAtorvastatin in Moderate Active Crohns Disease
Primary Purpose
Crohns Disease
Status
Completed
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
Atorvastatin
Sponsored by
About this trial
This is an interventional treatment trial for Crohns Disease
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Crohns disease
- C-reactive protein level > 2 mg/L in absence of an infection
- Fecal calprotectin > 250 mg/kg or CDAI > 150
Exclusion Criteria:
- CDAI > 450
- Prednisolone dosage above 15 mg/day
Sites / Locations
- Department of Medicine, Division of Gastroenterology and Hepatology
Outcomes
Primary Outcome Measures
Inflammatory markers in plasma before and after treatment.
Secondary Outcome Measures
Change in clinical activity index and mucosal inflammation after treatment.
Full Information
NCT ID
NCT00454545
First Posted
March 29, 2007
Last Updated
October 18, 2007
Sponsor
Skane University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00454545
Brief Title
Atorvastatin in Moderate Active Crohns Disease
Study Type
Interventional
2. Study Status
Record Verification Date
October 2007
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Skane University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Open pilot study to collect information regarding the effect of atorvastatin on patients with active Crohns disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohns Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Primary Outcome Measure Information:
Title
Inflammatory markers in plasma before and after treatment.
Secondary Outcome Measure Information:
Title
Change in clinical activity index and mucosal inflammation after treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Crohns disease
C-reactive protein level > 2 mg/L in absence of an infection
Fecal calprotectin > 250 mg/kg or CDAI > 150
Exclusion Criteria:
CDAI > 450
Prednisolone dosage above 15 mg/day
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olof Grip, MD, PhD
Organizational Affiliation
Malmo University Hospital, Region Skåne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anders Bredberg, MD, PhD
Organizational Affiliation
Malmo University Hospital, Region Skåne
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Gunnel Bredberg, MD, PhD
Organizational Affiliation
Malmo University Hospital, Region Skåne
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Medicine, Division of Gastroenterology and Hepatology
City
Malmö
ZIP/Postal Code
20502 Malmö
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
19421322
Citation
Grip O, Janciauskiene S. Atorvastatin reduces plasma levels of chemokine (CXCL10) in patients with Crohn's disease. PLoS One. 2009;4(5):e5263. doi: 10.1371/journal.pone.0005263. Epub 2009 May 6.
Results Reference
derived
Learn more about this trial
Atorvastatin in Moderate Active Crohns Disease
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