Rosuvastatin for Acute Systemic Crohn's disease: A mono-center randomized triaL

UMIN ID: UMIN000002074

Registered date:01/07/2009

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Crohn's disease
• Date of first enrollment: 2009/07/01
• Target sample size: 45
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Rosuvastatin (Crestor) 0mg/day: Control group
Rosuvastatin (Crestor) 5mg/day: Low-dose group
Rosuvastatin (Crestor) 20mg/day: High-dose group

Outcome(s)

• Primary Outcome: CDAI (Crohn's disease activity index) & IBDQ (a questionnaire for IBD patient) are evaluated at week 0,2,6,15(primary end-point),23(end).
• Secondary Outcome: CRP, Total-cholesterol, HDL/LDL-cholesterol, TG, and serum cytokines are evaluated at week 0,2,6,15(primary end-point),23(end).

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 65years-old
• Gender: Male and Female
• Exclude criteria: (1) Patients treating hyperlipidemia with or without statins. (2) Patients of hypothyroidism (TSH elevates 1.5 times or higher than the normal limits) (3) Patient with high creatine kinase (3.0 times or higher than the normal limits) (4) Serum creatinine higher than 2.0 mg/dl (5) Liver dysfunction (ALT elevates 2.0 times or higher than the normal limits) (6) Past episode of malignancy and/or alcoholic or drug dependence (7) Women under or expecting pregnancy (8) Patients of acute inflammatic disease (9) Patients with having past episode of severe allergy (10) Patients have been enrolled for other clinical trial within past 3 months and/or enrolling other trial currently (11) Patients less than 20 y.o. and/or more than 65 y.o. (12) Patient who have determined by their physicians to have any reason of unqualified

Related Information

• Primary Sponsor: Department of lower gastroenterology, Hyogo College of Medicine
• Source(s) of Monetary Support: N/A