Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Atorvastatin in Moderate Active Crohns Disease
This study has been completed.
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

Genetics Home Reference related topics: Crohn disease
MedlinePlus related topics: Crohn's Disease
Drug Information available for: Atorvastatin Atorvastatin calcium
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

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

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

Study placed in the following topic categories:
Digestive System Diseases
Gastrointestinal Diseases
Crohn Disease
Inflammatory Bowel Diseases
 Gastroenteritis
Intestinal Diseases
Atorvastatin

Additional relevant MeSH terms:
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Therapeutic Uses
Antilipemic Agents
 Enzyme Inhibitors
Anticholesteremic Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services