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NCT00454545 Clinical Trial

Atorvastatin in Moderate Active Crohns Disease

Crohns Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00454545
Other study ID # 010-02
Secondary ID
Status Completed
Phase Phase 2
First received March 29, 2007
Last updated October 18, 2007
Start date October 2006
Est. completion date October 2007

Study information
Verified date October 2007
Source Skane University Hospital
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date October 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• Atorvastatin

Locations
Country Name City State
Sweden Department of Medicine, Division of Gastroenterology and Hepatology Malmö

Sponsors (1)
Lead Sponsor Collaborator
Skane University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary Inflammatory markers in plasma before and after treatment.
Secondary Change in clinical activity index and mucosal inflammation after treatment.
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