UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009697 |
|---|---|
| Receipt number | 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 23:22:16 |
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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
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
shinzaki@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011369
