Unique ID issued by UMIN | UMIN000008352 |
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Receipt number | R000009822 |
Scientific Title | Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative Colitis |
Date of disclosure of the study information | 2012/08/01 |
Last modified on | 2018/01/02 21:47:15 |
Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative Colitis
Once Daily Oral Mesalazine Swich Trial in UC-Patients
Switch Trial from Several Times to Once Daily Oral Mesalazine Administration in Patients with Quiescent Ulcerative Colitis
Once Daily Oral Mesalazine Swich Trial in UC-Patients
Japan |
Ulcerative Colitis
Medicine in general | Gastroenterology |
Others
NO
Evaluation of adherence and efficacy of maintenance of remission by switching from several times to once daily oral mesalazine administration in patients with quiescent ulcerative colitis
Safety,Efficacy
Changes of clinical activity index (CAI)in week 48
Changes of adherece in week 48
Changes of stool calprotectin concentration in week 48
Remission rates in week 48
Changes of CRP titer in week 48
Changes of stool number and bloody stoolin week 48
Safety
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Switch from several times to once daily oral mesalazine administration
15 | years-old | <= |
70 | years-old | > |
Male and Female
Patients who keeps remission state more than 8 weeks by several times oral mesarazine administration
CAI score is 4 and less
Patients who have informed consent
Patients refractory to oral mesalazine
Patients treated by infliximab within 12 weeks
Patients treated by azathiopurine and 6MP within 12 weeks
Patients treated by tacrolimus within 12 weeks
Patients treated by leukocyteapheresis within 12 weeks
Patients in maternity and lactation
Patients treated by surgery within 6 months
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
NO
2012 | Year | 08 | Month | 01 | Day |
Unpublished
Completed
2012 | Year | 07 | Month | 31 | Day |
2012 | Year | 08 | Month | 01 | Day |
2017 | Year | 03 | Month | 31 | Day |
2012 | Year | 07 | Month | 05 | Day |
2018 | Year | 01 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009822
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