UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023525 |
|---|---|
| Receipt number | R000027096 |
| Scientific Title | Phase I/II clinical trial for aGalCer resembling medicine,OCH in patients with Crohn s disease |
| Date of disclosure of the study information | 2016/08/08 |
| Last modified on | 2019/03/08 13:41:13 |
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Basic information
Public title
Phase I/II clinical trial for aGalCer resembling medicine,OCH in patients with Crohn s disease
Acronym
OCH NCNP1
Scientific Title
Phase I/II clinical trial for aGalCer resembling medicine,OCH in patients with Crohn s disease
Scientific Title:Acronym
OCH NCNP1
Region
| Japan |
Condition
Condition
Crohn disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The safety of tolerability of OCH is evaluated in patients with Crohn s disease
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I,II
Assessment
Primary outcomes
Adverse event
Key secondary outcomes
Clinical efficacy
Pharmacokinetics of OCH
Pharmacodynamics of OCH
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cohort A (0.3mg daily) 4 cases
Interventions/Control_2
Cohort B (3mg daily) 4 cases
Interventions/Control_3
Cohort C (6mg daily) 4 cases
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) The patient who has been diagnosed as Crohn s disease
2) Patients whose CDAI is 150-450
others criteria can not uploaded due to the space.
Key exclusion criteria
1) The patient who is suspected as other inflammatory bowel disease except Crohn s disease
2) Patient who will need bowel resection within 12 weeks after the entry of clinical trial.
3) Patient who is entering to another clinical trial or who receive medical treatment in any other clinical trial within 12 weeks prior to entry of the present clinical trial.
others criteria can not uploaded due to the space.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takanori Kanai and Makoto Naganuma |
Organization
School of Medicine, Keio University
Division name
Department of Internal Medicine
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan
TEL
03-3353-1211
nagamakoto@z7.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoko Ito |
Organization
Keio University Hospital
Division name
Planning and Management Office Clinical and Translational Research Center
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582 Japan
TEL
03-5315-4278
Homepage URL
pmo@ccr.med.keio.ac.jp
Sponsor or person
Institute
School of Medicine, Keio University
Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
慶應義塾大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 08 | 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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 08 | Month | 06 | Day |
Last modified on
| 2019 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027096
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
