UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028089 |
|---|---|
| Receipt number | 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 22:25:11 |
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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
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
nagamakoto@keio.jp
Sponsor or person
Institute
School of Medicine, Keio University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032158
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
