Unique ID issued by UMIN | UMIN000002074 |
---|---|
Receipt number | R000002527 |
Scientific Title | Rosuvastatin for Acute Systemic Crohn's disease: A mono-center randomized triaL |
Date of disclosure of the study information | 2009/07/01 |
Last modified on | 2014/05/08 15:07:03 |
Rosuvastatin for Acute Systemic Crohn's disease: A mono-center randomized triaL
RASCAL study
Rosuvastatin for Acute Systemic Crohn's disease: A mono-center randomized triaL
RASCAL study
Japan |
Crohn's disease
Gastroenterology |
Others
NO
To evaluate the clinical efficiency of Rosuvastatin calcium (Crestor) in acute Crohn's disease patients
Efficacy
Confirmatory
Pragmatic
Phase II
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).
CRP, Total-cholesterol, HDL/LDL-cholesterol, TG, and serum cytokines are evaluated at week 0,2,6,15(primary end-point),23(end).
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Dose comparison
NO
NO
Institution is not considered as adjustment factor.
YES
Central registration
3
Treatment
Medicine |
Rosuvastatin (Crestor) 0mg/day: Control group
Rosuvastatin (Crestor) 5mg/day: Low-dose group
Rosuvastatin (Crestor) 20mg/day: High-dose group
20 | years-old | <= |
65 | years-old | > |
Male and Female
Acute Crohn's disease patient with more than 200 points and less than 450 points in the Crohn's activity index (CDAI), and higher than 0.5mg/dl of serum CRP level at enrollment. Candidate has to agree to be enrolled for the study under sufficient written informed consent.
(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
45
1st name | |
Middle name | |
Last name | Shiro Nakamura |
Hyogo College of Medicine
Department of lower gastroenterology
1-1 Mukogawa, Nishinomiya, Hyogo Pref.
0798-45-6660
shiro@hyo-med.ac.jp
1st name | |
Middle name | |
Last name | Ken Fukunaga |
Hyogo College of Medicine
Department of lower gastroenterology
1-1 Mukogawa, Nishinomiya, Hyogo Pref.
0798-45-6662
kebe@hyo-med.ac.jp
Department of lower gastroenterology, Hyogo College of Medicine
N/A
Self funding
NO
兵庫医科大学病院
2009 | Year | 07 | Month | 01 | Day |
Unpublished
Completed
2009 | Year | 06 | Month | 08 | Day |
2009 | Year | 07 | Month | 01 | Day |
2012 | Year | 07 | Month | 01 | Day |
2012 | Year | 09 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2014 | Year | 03 | Month | 31 | Day |
2009 | Year | 06 | Month | 13 | Day |
2014 | Year | 05 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002527
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