UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005314 |
|---|---|
| Receipt number | R000006319 |
| Scientific Title | Evaluation of Mucosal healing effects of Intensive GCAP on in patients with ulcerative colitis |
| Date of disclosure of the study information | 2011/03/25 |
| Last modified on | 2013/09/25 13:39:19 |
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Basic information
Public title
Evaluation of Mucosal healing effects of Intensive GCAP on in patients with ulcerative colitis
Acronym
Evaluation of Mucosal healing effects of Intensive GCAP on in patients with ulcerative colitis
Scientific Title
Evaluation of Mucosal healing effects of Intensive GCAP on in patients with ulcerative colitis
Scientific Title:Acronym
Evaluation of Mucosal healing effects of Intensive GCAP on in patients with ulcerative colitis
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of present study is to clarify the effects of Intensive GCAP on the mucosal healing in patients with ulcerative colitis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Mucosal healing rate(Endoscopic Score of Mayo index)
Key secondary outcomes
-Remission rate(Mayo and CAI score)
-Efficacy(Mayo and CAI score)
-Expression of mRNA level of inflammatory cytokines and regenerating factors in mucosa
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
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients receive GCAP eleven times at most, twice per a week
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Moderate, severe and fulminating active ulcerative colitis
Key exclusion criteria
-Granulocyte count is not more than 2,000/mm3
-Serious infectious disease
-Proctitis
-Use of enema, suppository(Mesalazine,sulfasalazine stroids) within last 2 weeks
-Introduce or increase the dosage of Mesalazine,sulfasalazine within the last 4 weeks
-Introduce or increase the dosage of Steroids (intravenous infusion,oral) within the last 2 weeks
-Use of total parental nutrition within last 4 weeks
-Introduce or increase the dosage of Cycrosporine,tacrolimus within the last 4 weeks
-Introduce or increase the dosage of 6-mercaptopurine, azathioprine within the last 4 weeks
-Use of Infliximab with in last 6 weeks
-Use of GCAP,LCAP with in last 8 weeks
-History of colectomy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Soichiro Miura |
Organization
National Defense Medical College
Division name
Second Department of Internal Medicine
Zip code
Address
3-2 Namiki, Tokorozawa, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
National Defense Medical College
Division name
Second Department of Internal Medicine
Zip code
Address
TEL
04-2995-1211
Homepage URL
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
JIMRO co, Ltd
Organization
Division
Category of Funding Organization
Profit organization
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
岩下悦郎消化器内科クリニック(埼玉県)、大森敏秀胃腸科クリニック(埼玉県)、埼玉医科大学総合医療センター(埼玉県)、埼玉医科大学国際医療センター(埼玉県)、自治医科大学附属さいたま医療センター(埼玉県)、さいたま赤十字病院(埼玉県)、つづきクリニック(東京都)、埼玉社会保険病院内科(埼玉県)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 03 | Month | 25 | 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
Completed
Date of protocol fixation
| 2011 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 03 | Month | 01 | 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
| 2011 | Year | 03 | Month | 25 | Day |
Last modified on
| 2013 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006319
