UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005823 |
|---|---|
| Receipt number | R000006886 |
| Scientific Title | Examination of efficacy and safety of new 5-ASA preparation for ulcerative colitis, and new method of evaluating disease condition by measuring fecal concentration of calprotectin. |
| Date of disclosure of the study information | 2011/06/21 |
| Last modified on | 2013/12/24 12:30:06 |
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Basic information
Public title
Examination of efficacy and safety of new 5-ASA preparation for ulcerative colitis, and new method of evaluating disease condition by measuring fecal concentration of calprotectin.
Acronym
Establishing the efficacy evaluating method of Asacol for ulcerative colitis by measuring fecal concentration of calprotectin.
Scientific Title
Examination of efficacy and safety of new 5-ASA preparation for ulcerative colitis, and new method of evaluating disease condition by measuring fecal concentration of calprotectin.
Scientific Title:Acronym
Establishing the efficacy evaluating method of Asacol for ulcerative colitis by measuring fecal concentration of calprotectin.
Region
| Japan |
Condition
Condition
Ulcerative colitis
Classification by specialty
| Medicine in general | Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The condition of ulcerative colitis is evaluated by measuring fecal concentration of calprotection, and the consistency of evaluation with an endoscope diagnosis is investigated. The calprotectin concentration in fecal is tested, in order to determine the efficacy of the Asacol.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
non-relapse rate by CAI score after three months
Key secondary outcomes
Clinical Activity Index
Patient Diary
Non-relapse rate after 1,2,3 months
Inflammatory response score (WBC,Plt, ESR, CRP)
Safety
Remission period (month)
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
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The efficacy and the safety of the Asacol is examined by administering Asacol 2.4g/day switching from Pentasa 3g/day, and the medication of Asacol is continued for 12 weeks if at all possible.
Interventions/Control_2
The efficacy and the safety of the Asacol is examined by administering Asacol 3.6g/day switching from Pentasa 4g/day, and the medication of Asacol is continued for 12 weeks if at all possible.
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
Mild and moderate ulcerative colitis patients taking Pentasa medication in combination with the steroid preparation or the topical formulation.
Key exclusion criteria
(1)Patients without agreement of this study
(2)Pregnant women and women suspected of being pregnant
(3)Patients with history of total or partial colectomy operation.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taro Osada |
Organization
Juntendo University
Division name
Department of Gastroenterology,
Zip code
Address
2-1-1 Hongo,Bunkyo-ku,Tokyo,Japan
TEL
03-3813-3111
otaro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taro Osada |
Organization
Juntendo University
Division name
Department of Gastroenterology,
Zip code
Address
2-1-1 Hongo,Bunkyo-ku,Tokyo,Japan
TEL
03-3813-3111
Homepage URL
otaro@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 06 | Month | 21 | 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
Open public recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 06 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 06 | Month | 21 | Day |
Last modified on
| 2013 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006886
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