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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025961
Receipt No. R000029845
Scientific Title The study of effect of Alfacalcidol treatment on Crohn's disease
Date of disclosure of the study information 2017/03/01
Last modified on 2019/08/23

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Basic information
Public title The study of effect of Alfacalcidol treatment on Crohn's disease
Acronym The study of effect of Alfacalcidol treatment on Crohn's disease
Scientific Title The study of effect of Alfacalcidol treatment on Crohn's disease
Scientific Title:Acronym The study of effect of Alfacalcidol treatment on Crohn's disease
Region
Japan

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

Objectives
Narrative objectives1 To investigate the effeicacy of Alfacalcidol treatment for Crohn's disease
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvement rate on endoscopic score after 3 month.
Key secondary outcomes Improvement rate on clinical score
comparison of endoscopic score, clinical score, biomarker between before and after treatment

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral treatment of Alfacalcidol 1 microgram/day for 3 month
Interventions/Control_2
Interventions/Control_3
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Crohn's disease of ileocolic/colitis type
Male and female
over 18 year old
Patient who has more than 220 in CDAI score
written consent of participation for this study
Key exclusion criteria Patient who has moderate to severe colitis
Hypercalcemia
Patient who is taking Calcium formulation,Vitamin D and Vitamin D analog
Patient who is taking medicine including magnesium, digitalis, PTH formulation.
Expectant and nursing mothers
Target sample size 31

Research contact person
Name of lead principal investigator
1st name Masanao
Middle name
Last name Nakamura
Organization Nagoya University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 466-8560
Address 65 Tsurumai, Shouwa, Nagoya-City, Aichi
TEL 0527442172
Email osa-wata@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Tsunaki
Middle name
Last name Sawada
Organization Nagoya University Hospital
Division name Department of Gastroenterology and Hepatology
Zip code 466-8560
Address 65 Tsurumai, Shouwa, Nagoya-City, Aichi
TEL 0527442172
Homepage URL
Email t.sawada@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization Nagoya University Graduate School of Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nagoya University Certified Review Board
Address 65-banchi, Tsurumai-cho, Showa-ku, Aichi
Tel 052-744-2479
Email ethics@med.nagoya-u.ac.jp

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

Other administrative information
Date of disclosure of the study information
2017 Year 03 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 Enrolling by invitation
Date of protocol fixation
2017 Year 02 Month 01 Day
Date of IRB
2017 Year 05 Month 21 Day
Anticipated trial start date
2017 Year 05 Month 21 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 02 Month 01 Day
Last modified on
2019 Year 08 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029845

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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