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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009697
Receipt No. R000011369
Scientific Title Analysis of factors affecting therapeutic efficacy in intestinal inflammation
Date of disclosure of the study information 2013/01/04
Last modified on 2017/08/07

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Basic information
Public title Analysis of factors affecting therapeutic efficacy in intestinal inflammation
Acronym Analysis of factors affecting therapeutic efficacy in intestinal inflammation
Scientific Title Analysis of factors affecting therapeutic efficacy in intestinal inflammation
Scientific Title:Acronym Analysis of factors affecting therapeutic efficacy in intestinal inflammation
Region
Japan

Condition
Condition inflammatory bowel disease
Classification by specialty
Gastroenterology Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate pharmacokinetics in intestinal mucosa and clinical parameters in patients with inflammatory bowel disease.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Association of concentration of biological drugs in inflammatory/non-inflammatory mucosa with clincal parameters including laboratory data, clinical/endoscopic activity scores
Key secondary outcomes

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 Diagnosis
Type of intervention
Other
Interventions/Control_1 endoscopic biopsy
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patients who are administrating or have a plan to administer biologics for the treatment of inflammatory bowel disease.
2. Patients who gave written informed consent.
Key exclusion criteria 1. Patients who are diagnosed as ileus.
2. Patients who receive anticoagulant and/or antiplatelet agents.
3. Patients whose platelet count was less than 50,000/microl.
4. Patients who are pregnant or suspected of being pregnant.
5. Patients who have psychiatric diseases.
6. Patients who are ineligible for this study as judged by the investigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tetsuo Takehara
Organization Osaka University Graduate School of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 2-2 K1, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3621
Email takehara@gh.med.oska-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichiro Shinzaki
Organization Osaka University Graduate School of Medicine
Division name Gastroenterology and Hepatology
Zip code
Address 2-2 K1, Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-3621
Homepage URL http://www.med.osaka-u.ac.jp/pub/gh/index.html
Email shinzaki@gh.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization None
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
2013 Year 01 Month 04 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2012 Year 12 Month 17 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 01 Month 04 Day
Last modified on
2017 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011369

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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