Recruiting

Pravastatin

Sponsor:

University of Virginia

Code:

NCT00599625

Conditions

Crohn's Disease

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Pravastatin

Study Details

Brief summary:

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.

Conditions

Crohn's Disease

Study ID

NCT00599625

Start date

Oct, 2004

Status verified date

Mar, 2011

Completion date

Dec, 2011

Anticipated

Primary completion date

Dec, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 1

Patients with active Crohn's Disease

Interventions

Pravastatin

80mg administered daily for 6 consecutive weeks

Primary outcome measure

  • Primary outcome will be clinical benefit which will be defined as a decrease in HBI, fecal lactoferrin, CRP and/or ESR at 6 weeks compared with baseline values [ Time Frame: 6 weeks ]

Central Contacts and Locations

Central contacts

Brian Behm, MD

434-924-2959bwb2c@virginia.edu

Sandra Oliphant

434-982-0871slo2n@virginia.edu

Locations

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22908

Contacts

Brian Behm, MD

434-924-2959bwb2c@virginia.edu

Meredith Gross

434-924-2753mpg8b@virginia.edu

Principal Investigator:

Brian Behm, MD

More Information

Sponsor

University of Virginia

Last update posted

Mar 8, 2011

Last verified

Mar, 2011

Keywords

  • Crohn's Disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Virginia on 2011-03-08.