NCT00454545

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2006

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2007

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2007

Completed
Last Updated

October 22, 2007

Status Verified

October 1, 2007

First QC Date

March 29, 2007

Last Update Submit

October 18, 2007

Conditions

Crohns Disease

Outcome Measures

Primary Outcomes (1)

  • Inflammatory markers in plasma before and after treatment.

Secondary Outcomes (1)

  • Change in clinical activity index and mucosal inflammation after treatment.

Interventions

AtorvastatinDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • CDAI \> 450
  • Prednisolone dosage above 15 mg/day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Medicine, Division of Gastroenterology and Hepatology

Malmo, 20502 Malmö, Sweden

Location

Related Publications (1)

  • Grip O, Janciauskiene S. Atorvastatin reduces plasma levels of chemokine (CXCL10) in patients with Crohn's disease. PLoS One. 2009;4(5):e5263. doi: 10.1371/journal.pone.0005263. Epub 2009 May 6.

    PMID: 19421322DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Olof Grip, MD, PhD

    Malmo University Hospital, Region Skåne

    PRINCIPAL INVESTIGATOR

  • Anders Bredberg, MD, PhD

    Malmo University Hospital, Region Skåne

    STUDY CHAIR

  • Gunnel Bredberg, MD, PhD

    Malmo University Hospital, Region Skåne

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 29, 2007

First Posted

March 30, 2007

Study Start

October 1, 2006

Study Completion

October 1, 2007

Last Updated

October 22, 2007

Record last verified: 2007-10

Locations

SE(1)