Pravastatin Therapy in Patients With Active Crohn's Disease: A Pilot Study

Status unconfirmed · Not applicable

Conditions studied: Crohn's Disease

In brief

The primary objective of this study is to provide data regarding clinical and immunologic activity of oral doses of pravastatin 80mg administered daily for 6 consecutive weeks, for the treatment of active Crohn's disease as shown by the Harvey-Bradshaw Index (HBI) and/or elevated C-reactive protein (CRP). We hypothesize pravastatin will significantly reduce symptoms of Crohn's disease, as shown by a decrease in HBI, by the end of the study period. Secondary outcomes of this study include the effect of pravastatin on C-reactive protein, ESR, proinflammatory cytokines, and fecal lactoferrin.

Key facts

Study ID

NCT00599625

Run by

University of Virginia

People needed

40

Starts

2004-10-01

Expected to finish

2011-12-01

Last updated by the study team

2011-03-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males and non-pregnant females on an adequate contraceptive regimen aged 18-65
• Active Crohn's disease (HBI >5 or serum CRP concentration above the upper limits of normal on initial labs.
• Stable regimen of medications for treatment of Crohn's disease for at least 4 weeks and will continue the current regimen for the 6 weeks of drug administration. Patients taking azathioprine/6-MP and methotrexate will need to be on a stable dose of these medications for a minimum of 8 weeks prior to study enrollment.
• Medications for the treatment of Crohn's disease meeting inclusion criteria are azathioprine/6-MP, methotrexate, mesalamine, ciprofloxacin, metronidazole, budesonide, and/or less than or equal to 20mg prednisone or an equivalent steroid per day

You may not qualify if…

• Patients less than 18 or greater than 65
• Current therapy with a statin or alternative medication for hyperlipidemia
• Hypersensitivity or known adverse reaction to statin therapy in the past
• Pregnancy
• Use of cyclosporin, erythromycin, and/or greater than 20mg of prednisone or its equivalent per day during the 4 weeks prior to study entry and/or during the 6 week study drug administration period.
• Use of infliximab during 8 weeks prior to study entry and/or during the 6 week study drug administration period.
• AST, ALT or CK more than twice the upper limits of normal on baseline laboratory data
• Serum creatinine greater than 1.5 or estimated creatinine clearance less than 40mL/min on baseline laboratory data.
• Clinically significant perianal fistulae
• Patients with diverting or end ostomy.
• Experimental therapy for Crohn's disease in the 4 weeks prior to study entry
• Presence of medical condition or disease that, in the opinion of the investigators, may place the patient at unacceptable risk for study participation, including, but not limited to, pregnancy, lactation, and/or inability/unwillingness to adhere to a contraceptive regimen.

Where it is running

• University of Virginia — Charlottesville, Virginia, United States (enrolling)

Full record on ClinicalTrials.gov

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