Unique ID issued by UMIN | UMIN000034016 |
---|---|
Receipt number | R000038783 |
Scientific Title | The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study |
Date of disclosure of the study information | 2018/09/03 |
Last modified on | 2020/09/08 00:27:36 |
The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study
STABILITY study
The investigation for maintenance therapy by mesalazine enema after remission induction by budesonide form enema in patients with ulcerative colitis: Multicenter randomized controlled study
STABILITY study
Japan |
ulcerative colitis
Gastroenterology |
Others
NO
The investigation of remission maintenance therapy by mesalazine enema for the efficacy and safety after remission induction by budesonide form enema in patients with ulcerative colitis
Safety,Efficacy
Steroid-free endoscopic mucosal healing at week 48 after randomized allocation
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
2
Treatment
Medicine |
Additional remission maintenance therapy by mesalazine enema with continuation of concomitant treatment at the remission induction by budesonide form enema
The continuation of concomitant treatment at the remission induction by budesonide form enema (control group)
16 | years-old | <= |
Not applicable |
Male and Female
1: The patients with ulcerative colitis who were diagnosed according to the diagnostic criteria of the Research Committee on Inflammatory Bowel Disease in Japan
2: The patients with ulcerative colitis who were induced remission by the treatment of budesonide form enema (4 or more than 4 weeks)
1: The patients who are intolerant for mesalazine
2: The patients who were seemed to perform remission maintenance therapy by mesalazine enema at least 2 times per week during 48 weeks with stability
3: The patients who are difficult to perform 2 times total colonoscopy at the achievement of remission induction by budesonide form enema and week 48
4: The patients who are treated with only budesonide form enema at the randomization
5: The patients who had history of treatment with biologics or JAK inhibitor. However, the patients who were administrated with stable dose more than 6 months or withdrawn more than 4 months before can be enrolled.
6: The patients who were changed the dosage of concomitant immunomodulator within 3 months prior to registration
7: The patients who were changed the dosage of concomitant 5-aminosalicylate within 4 weeks prior to registration
8: The patients who were administrated steroid except budesonide form enema within 4 weeks prior to registration
9: The patients who are treated with topical 5-aminosalicylate (enema or suppository) at the registration. However, the patients who were withdrawn for the topical 5-aminosalicylate (enema or suppository) at the registration can be enrolled.
10: The patients who were indicated the lesion (1 or more than 1 of Mayo endoscopic subscore) at the proximal to splenic flexure by total colonoscopy after remission induction by budesonide form enema.
11: The patients who are treated with cytapheresis
12: The patients who were judged as unsuitable participant for registration of this study by physician
84
1st name | Kenji |
Middle name | |
Last name | Watanabe |
Hyogo College of Medicine
Department of Intestinal Inflammation Research
663-8501
1-1, Mukogawa-cho, Nishinomiya, Hyogo
0798-45-6663
ke-watanabe@hyo-med.ac.jp
1st name | Kenji |
Middle name | |
Last name | Watanabe |
Hyogo College of Medicine
Department of Intestinal Inflammation Research
663-8501
1-1, Mukogawa-cho, Nishinomiya, Hyogo
0798-45-6663
ke-watanabe@hyo-med.ac.jp
Hyogo College of Medicine
Hyogo College of Medicine, Center for Clinical Research and Education
Other
The ethical committee of Hyogo College of Medicine
1-1, Mukogawa-cho, Nishinomiya, Hyogo
0798-45-6066
rinri@hyo-med.ac.jp
NO
2018 | Year | 09 | Month | 03 | Day |
Unpublished
Terminated
2018 | Year | 07 | Month | 13 | Day |
2018 | Year | 10 | Month | 25 | Day |
2018 | Year | 12 | Month | 01 | Day |
2021 | Year | 05 | Month | 13 | Day |
2021 | Year | 05 | Month | 13 | Day |
2018 | Year | 09 | Month | 03 | Day |
2020 | Year | 09 | Month | 08 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038783
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |