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Atorvastatin in Moderate Active Crohns Disease

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ClinicalTrials.gov Identifier: NCT00454545
Recruitment Status : Completed
First Posted : March 30, 2007
Last Update Posted : October 22, 2007
Sponsor:
Information provided by:
Skane University Hospital

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

Condition or disease Intervention/treatment Phase
Crohns Disease Drug: Atorvastatin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : October 2006
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease




Primary Outcome Measures :
  1. Inflammatory markers in plasma before and after treatment.

Secondary Outcome Measures :
  1. Change in clinical activity index and mucosal inflammation after treatment.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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

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

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 Posted: March 30, 2007    Key Record Dates
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