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

NCT00599625 | Unknown

• 1 other identifier: 11453
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• 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

  6 weeks

Study Arms (1)

1

EXPERIMENTAL

Patients with active Crohn's Disease

Drug: Pravastatin

Interventions

Pravastatin DRUG

80mg administered daily for 6 consecutive weeks

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

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.

Sponsors & Collaborators

• University of Virginia: lead
• American College of Gastroenterology: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Brian Behm, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Behm, MD

CONTACT

434-924-2959; bwb2c@virginia.edu

Sandra Oliphant

CONTACT

434-982-0871; slo2n@virginia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 24, 2008
• Study Start: October 1, 2004
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: March 8, 2011

Record last verified: 2011-03

Locations

US (1)