Atorvastatin in moderat active Crohns disease

• Conditions: Crohn's disease is an idiopathic chronic inflammatory bowel disease thought to result from inappropriate and ongoing activation of the mucosal immune system driven by the presence of normal luminal flora. It may affect the hole gastrointestinal tract, from mouth to rectum, with symptoms such as diarrhea, weight lose, malabsorption, abdominal pain and fever.

• Registration Number: EUCTR2005-000496-17-SE
• Lead Sponsor: Region Skåne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-24
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Patients with a moderate active Crohns disease defiened as a C-reactive plasma level > 2 mg/ml in absence of an infection and; endoscopic apperence of active inflammation or a CDAI > 150.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients below the age of 18; a CDAI > 450; inability to leave informed consent; ongoing lipid lowering treatment; previous side effects to statin treatment; prednisolone dosage above 15 mg/day; and clinical significant kidney disease or aspartate aminotranspherase, alanine aminotranspherase, or kreatinine kinas above two times the upper reference level.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate if atorvastatin has a clinical antiinflammatory effect in the treatment of Crohn's disease.;Secondary Objective: ;Primary end point(s): The primary objective is to collect information regarding the effect of atorvastatin on patients with active Crohns disease. Patients will be evaluated by inflammatory markers in plasma; C-reactive protein, TNF-alpha and MCP-1, and the mucosal inflammation by feacal calprotectin.