Atorvastatin in Moderate Active Crohns Disease

This study has been completed.

Sponsor:

Information provided by:

Skane University Hospital

ClinicalTrials.gov Identifier:

NCT00454545

First received: March 29, 2007

Last updated: October 18, 2007

Last verified: October 2007

History of Changes

Tracking Information

First Received Date ^ICMJE

March 29, 2007

Last Updated Date

October 18, 2007

Start Date ^ICMJE

October 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Inflammatory markers in plasma before and after treatment.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00454545 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in clinical activity index and mucosal inflammation after treatment.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Atorvastatin in Moderate Active Crohns Disease

Official Title ^ICMJE

Not Provided

Brief Summary

Open pilot study to collect information regarding the effect of atorvastatin on patients with active Crohns disease.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Crohns Disease

Intervention ^ICMJE

Drug: Atorvastatin

Study Arm (s)

Not Provided

Publications *

Grip O, Janciauskiene S. Atorvastatin reduces plasma levels of chemokine (CXCL10) in patients with Crohn's disease. PLoS ONE. 2009;4(5):e5263. Epub 2009 May 6.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Estimated Enrollment ^ICMJE

Completion Date

October 2007

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT00454545

Other Study ID Numbers ^ICMJE

010-02

Has Data Monitoring Committee

Yes

Responsible Party

Not Provided

Study Sponsor ^ICMJE

Skane University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:	Olof Grip, MD, PhD	Malmo University Hospital, Region Skåne
Study Chair:	Anders Bredberg, MD, PhD	Malmo University Hospital, Region Skåne
Study Chair:	Gunnel Bredberg, MD, PhD	Malmo University Hospital, Region Skåne

Information Provided By

Skane University Hospital

Verification Date

October 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

To Top