Atorvastatin in Moderate Active Crohns Disease

This study has been completed.
Sponsor:
Information provided by:
Skane University Hospital
ClinicalTrials.gov Identifier:
NCT00454545
First received: March 29, 2007
Last updated: October 18, 2007
Last verified: October 2007
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
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

No publications provided by Skane University Hospital

Additional 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
Study First Received: March 29, 2007
Last Updated: October 18, 2007
Health Authority: Sweden: Medical Products Agency

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

ClinicalTrials.gov processed this record on July 26, 2014