Unique ID issued by UMIN | UMIN000004505 |
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Receipt number | R000005385 |
Scientific Title | Randomized controlled trial of 5 sessions per week and 2 sessions per week therapies of Adacolum |
Date of disclosure of the study information | 2010/12/01 |
Last modified on | 2018/01/02 21:27:39 |
Randomized controlled trial of 5 sessions per week and 2 sessions per week therapies of Adacolum
Randomized controlled trial of 5 sessions per week and 2 sessions per week therapies of Adacolum
Randomized controlled trial of 5 sessions per week and 2 sessions per week therapies of Adacolum
Randomized controlled trial of 5 sessions per week and 2 sessions per week therapies of Adacolum
Japan |
Ulcerative colitis
Gastroenterology |
Others
NO
To compare the efficacy and safety between 5 sessions and 2 sessions per week with Adocolumn in a prospective, randomized, controlled, non-blinded study for active ulceratie colitis
Safety,Efficacy
Confirmatory
Explanatory
Not applicable
The primary measure of response was clinical remission after one week by the evaluation of the CAI score
clinical remission at week 3
clinical response at week 1 and 3
safety
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
NO
NO
Institution is not considered as adjustment factor.
NO
2
Treatment
Device,equipment |
Patients in five sessions receive five Adacolumn sessions in first week, and two Adacolumn sessions in second and third weeks.
Patients in two sessions receive two Adacolumn sessions each in three weeks.
Not applicable |
Not applicable |
Male and Female
Patients who needs Adacolumn treatment and whose CAI score is over 6 degrees.
Patients whose granulocyte number is under 2,000/mm3, as well as who has or is suspected severe infections. However patients who recovered from infections can be enrolled.
50
1st name | |
Middle name | |
Last name | Shingo Kato |
Saitama Medical Center, Saitama Medical University
Department of Gastroenterology and Hepatology
1981 Kamoda, Kawagoe City, Saitama, Japan
049-228-3564
skato@saitama-med.ac.jp
1st name | |
Middle name | |
Last name | Shingo Kato |
Saitama Medical Center, Saitama Medical University
Department of Gastroenterology and Hepatology
1981 Kamoda, Kawagoe City, Saitama, Japan
049-228-3564
skato@saitama-med.ac.jp
Saitama Medical Center, Saitama Medical University
Saitama Medical Center, Saitama Medical University
Other
Japan
NO
2010 | Year | 12 | Month | 01 | Day |
Unpublished
Completed
2010 | Year | 12 | Month | 01 | Day |
2010 | Year | 12 | Month | 01 | Day |
2017 | Year | 03 | Month | 31 | Day |
2010 | Year | 11 | Month | 04 | Day |
2018 | Year | 01 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005385
Research Plan | |
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Research case data | |
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