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Atorvastatin in Moderate Active Crohns Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00454545
First Posted: March 30, 2007
Last Update Posted: October 22, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Skane University Hospital
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Skane 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00454545


Locations
Sweden
Department of Medicine, Division of Gastroenterology and Hepatology
Malmö, Sweden, 20502 Malmö
Sponsors and Collaborators
Skane 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00454545     History of Changes
Other Study ID Numbers: 010-02
First Submitted: March 29, 2007
First Posted: March 30, 2007
Last Update Posted: October 22, 2007
Last Verified: October 2007

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Atorvastatin Calcium
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors