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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005314
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute National Defense Medical College
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006319

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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