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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002074
Receipt No. 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

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Basic information
Public title Rosuvastatin for Acute Systemic Crohn's disease: A mono-center randomized triaL
Acronym RASCAL study
Scientific Title Rosuvastatin for Acute Systemic Crohn's disease: A mono-center randomized triaL
Scientific Title:Acronym RASCAL study
Region
Japan

Condition
Condition Crohn's disease
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical efficiency of Rosuvastatin calcium (Crestor) in acute Crohn's disease patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes 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).
Key secondary outcomes CRP, Total-cholesterol, HDL/LDL-cholesterol, TG, and serum cytokines are evaluated at week 0,2,6,15(primary end-point),23(end).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Rosuvastatin (Crestor) 0mg/day: Control group
Interventions/Control_2 Rosuvastatin (Crestor) 5mg/day: Low-dose group
Interventions/Control_3 Rosuvastatin (Crestor) 20mg/day: High-dose group
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 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.
Key exclusion 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
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shiro Nakamura
Organization Hyogo College of Medicine
Division name Department of lower gastroenterology
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo Pref.
TEL 0798-45-6660
Email shiro@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ken Fukunaga
Organization Hyogo College of Medicine
Division name Department of lower gastroenterology
Zip code
Address 1-1 Mukogawa, Nishinomiya, Hyogo Pref.
TEL 0798-45-6662
Homepage URL
Email kebe@hyo-med.ac.jp

Sponsor
Institute Department of lower gastroenterology, Hyogo College of Medicine
Institute
Department

Funding Source
Organization N/A
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 兵庫医科大学病院

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2009 Year 07 Month 01 Day
Last follow-up date
2012 Year 07 Month 01 Day
Date of closure to data entry
2012 Year 09 Month 01 Day
Date trial data considered complete
2012 Year 12 Month 01 Day
Date analysis concluded
2014 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2009 Year 06 Month 13 Day
Last modified on
2014 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002527

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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