Atorvastatin in Moderate Active Crohns Disease

October 18, 2007 updated by: Skane University Hospital
Open pilot study to collect information regarding the effect of atorvastatin on patients with active Crohns disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Malmö, Sweden, 20502 Malmö
        • Department of Medicine, Division of Gastroenterology and Hepatology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Inflammatory markers in plasma before and after treatment.

Secondary Outcome Measures

Outcome Measure
Change in clinical activity index and mucosal inflammation after treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2006

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

March 29, 2007

First Submitted That Met QC Criteria

March 29, 2007

First Posted (Estimate)

March 30, 2007

Study Record Updates

Last Update Posted (Estimate)

October 22, 2007

Last Update Submitted That Met QC Criteria

October 18, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 010-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Crohns Disease

Clinical Trials on Atorvastatin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kosovo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe