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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023525
Receipt No. 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

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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
Email 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
Email pmo@ccr.med.keio.ac.jp

Sponsor
Institute School of Medicine, Keio University
Department of Internal Medicine
Institute
Department

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
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 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
URL(English) https://upload.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


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