Crohns DiseasePhase 2NCT00454545
Atorvastatin in Moderate Active Crohns Disease
A Phase 2 study testing Atorvastatin in people with Crohns Disease, run by Skane University Hospital at 1 site in Sweden.
Trial summary
Open pilot study to collect information regarding the effect of atorvastatin on patients with active Crohns disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohns Disease
- What is being tested?
- Atorvastatin
- How many people
- 12 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2006to Oct 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- CDAI > 450
- Prednisolone dosage above 15 mg/day
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Medicine, Division of Gastroenterology and Hepatology
Malmö, 20502 Malmö
About this study
Open pilot study to collect information regarding the effect of atorvastatin on patients with active Crohns disease.
- Conditions
- Crohns Disease
- Being tested
- Atorvastatin
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtorvastatinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory markers in plasma before and after treatment.
Secondary outcomes (1)
Change in clinical activity index and mucosal inflammation after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2007 (estimated)
- Study startOct 2006
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohns DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Skane University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Olof Grip, MD, PhD, Principal investigator, Malmo University Hospital, Region SkåneAnders Bredberg, MD, PhD, Study chair, Malmo University Hospital, Region SkåneGunnel Bredberg, MD, PhD, Study chair, Malmo University Hospital, Region Skåne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00454545
- Sponsor's protocol ID
- 010-02
- Status last verified
- Oct 2007
- First submitted
- 29 Mar 2007
- Last updated
- 22 Oct 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19421322
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Atorvastatin in Moderate Active Crohns Disease
- ClinicalTrials.gov ID
- NCT00454545
- Acronym / sponsor ID
- 010-02
- Conditions
- Crohns Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Skane University HospitalUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Oct 2007 (actual)
- First posted
- 30 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open pilot study to collect information regarding the effect of atorvastatin on patients with active Crohns disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- CDAI > 450
- Prednisolone dosage above 15 mg/day
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atorvastatin | Drug | – |
Primary outcome
Inflammatory markers in plasma before and after treatment.
1 secondary outcome
Change in clinical activity index and mucosal inflammation after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2007.
- Derived from this study: PubMed 19421322Grip 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olof Grip, MD, PhD principal investigator
Malmo University Hospital, Region Skåne
Anders Bredberg, MD, PhD study chair
Malmo University Hospital, Region Skåne
Gunnel Bredberg, MD, PhD study chair
Malmo University Hospital, Region Skåne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Atorvastatin in people with Crohns Disease, run by Skane University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory markers in plasma before and after treatment.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00454545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2007.