Atorvastatin in Moderate Active Crohns Disease

This study has been completed.

First Received: March 29, 2007 Last Updated: October 18, 2007 History of Changes

Sponsored by:	Malmö University Hospital
Information provided by:	Malmö University Hospital
ClinicalTrials.gov Identifier:	NCT00454545

Purpose

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

Condition	Intervention	Phase
Crohns Disease	Drug: Atorvastatin	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Atorvastatin Atorvastatin calcium

U.S. FDA Resources

Further study details as provided by Malmö University Hospital:

Primary Outcome Measures:

Inflammatory markers in plasma before and after treatment.

Secondary Outcome Measures:

Change in clinical activity index and mucosal inflammation after treatment.

Estimated Enrollment:	12
Study Start Date:	October 2006
Study Completion Date:	October 2007

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454545

Locations

Sweden
Department of Medicine, Division of Gastroenterology and Hepatology
Malmö, Sweden, 20502 Malmö

Sponsors and Collaborators

Malmö University Hospital

Investigators

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

More Information

No publications provided by Malmö University Hospital

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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.

Study ID Numbers:	010-02
Study First Received:	March 29, 2007
Last Updated:	October 18, 2007
ClinicalTrials.gov Identifier:	NCT00454545 History of Changes
Health Authority:	Sweden: Medical Products Agency

Study placed in the following topic categories:

Antimetabolites
Crohn's Disease
Ileitis
Gastrointestinal Diseases
Enteritis
Antilipemic Agents
Inflammatory Bowel Diseases
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Intestinal Diseases
Ileal Diseases
Digestive System Diseases
Crohn Disease
Gastroenteritis
Atorvastatin

Additional relevant MeSH terms:

Antimetabolites
Molecular Mechanisms of Pharmacological Action
Ileitis
Gastrointestinal Diseases
Enteritis
Antilipemic Agents
Inflammatory Bowel Diseases
Enzyme Inhibitors
Anticholesteremic Agents

Hydroxymethylglutaryl-CoA Reductase Inhibitors
Intestinal Diseases
Ileal Diseases
Pharmacologic Actions
Digestive System Diseases
Therapeutic Uses
Crohn Disease
Gastroenteritis
Atorvastatin

ClinicalTrials.gov processed this record on September 10, 2009