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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028089
Receipt No. R000032158
Scientific Title Prospective cohort study of medication for inflammatory bowel disease
Date of disclosure of the study information 2017/07/06
Last modified on 2017/07/05

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Basic information
Public title Prospective cohort study of medication for inflammatory bowel disease
Acronym Prospective cohort study of medication for inflammatory bowel disease
Scientific Title Prospective cohort study of medication for inflammatory bowel disease
Scientific Title:Acronym Prospective cohort study of medication for inflammatory bowel disease
Region
Japan

Condition
Condition inflammatory bowel disease
Classification by specialty
Medicine in general Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study aimed to evaluate the efficacy and safety of patients treated with inflammatory bowel disease for ulcerative colitis and Crohn's disease patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The rate of clinical efficacy at 8 weeks after initiation of treatment
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1 Ministry of Health, Labor and Welfare Survey Study on Intractable Inflammatory Bowel Disease Disorder Patients newly intervening therapeutically among cases diagnosed as ulcerative colitis or Crohn's disease according to diagnostic criteria.
2 Patient who obtained consent of this study.
3 Patients over 16 years of age.
Key exclusion criteria 1 patients suspected of having intestinal inflammation other than UC and Crohn's disease (infectious enteritis, etc.).
2 Patients with symptomatic digestive tract stenosis.
3 Patient planning resection of colon.
4 Severe infections Patients with complications.
5 Other patients who judged that the physician in charge is inappropriate to incorporate into this study.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Makoto Naganuma
Organization School of Medicine, Keio University
Division name Gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Email nagamakoto@keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Naganuma
Organization School of Medicine, Keio University
Division name Gastroenterology and Hepatology
Zip code
Address 35 Shinanomachi, Shinjuku-ku, Tokyo
TEL 03-3353-1211
Homepage URL
Email nagamakoto@keio.jp

Sponsor
Institute School of Medicine, Keio University
Institute
Department

Funding Source
Organization School of Medicine, Keio University
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

Other administrative information
Date of disclosure of the study information
2017 Year 07 Month 06 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 Open public recruiting
Date of protocol fixation
2017 Year 06 Month 07 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information rate of response and clinical remission, frequency and type of side effects. Albumin, ESR, CRP, WBC, Plt (albumin, CRP, WBC, Plt), the transition of disease activity (partial Mayo score, CDAI), symptomatic transition (stool frequency, nocturia diarrhea, bloody stool, abdominal pain, fever, general evaluation) , Fecal occult blood), transition of endoscopic findings (Mayo score, activity). Side effects, presence or absence of adverse events.

Management information
Registered date
2017 Year 07 Month 05 Day
Last modified on
2017 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032158

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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