Unique ID issued by UMIN | UMIN000010168 |
---|---|
Receipt number | R000011906 |
Scientific Title | Segmental Endoscopic Evaluation of Combined Oral and Topical Mesalazine (Pentasa®) in patients with mild-to-moderate Ulcerative Colitis (UC) |
Date of disclosure of the study information | 2013/03/08 |
Last modified on | 2013/03/05 17:25:29 |
Segmental Endoscopic Evaluation of Combined Oral and Topical Mesalazine (Pentasa®) in patients with mild-to-moderate Ulcerative Colitis (UC)
Segmental Endoscopic Evaluation in patients with mild-to-moderate UC
Segmental Endoscopic Evaluation of Combined Oral and Topical Mesalazine (Pentasa®) in patients with mild-to-moderate Ulcerative Colitis (UC)
Segmental Endoscopic Evaluation in patients with mild-to-moderate UC
Japan |
ulcerative colitis
Gastroenterology |
Others
NO
To investigate endoscopic improvement in UC patients treated with combination of oral and topical mesalazine by segmental endoscopic evaluation
Efficacy
Exploratory
Pragmatic
Not applicable
Mucosal healing defined as Mayo endoscopic score = 0, 1
Endoscopic improvement by segmental endoscopic evaluation
Improvement of disease activity in UCDAI score and/or UCDAI sub-scores
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Combination therapy of oral Pentasa 4g/day with Pentasa enema 1g/day for 8 weeks
15 | years-old | <= |
75 | years-old | >= |
Male and Female
1) Patients with active mild-to-moderate UC
2) Patients treated with oral mesalazine (≤ 4g/day) or oral sulfasalazine (≤ 4.5g/day)
1)Patients receiving topical mesalazine, topical sulfasalazine within 14 days prior to study entry
2)Patients receiving any steroid within 14 days prior to study entry
3)Patients treated with immunosuppressive agents or anti TNF-a antibody during 90 days prior to study enrolment
4)Patients receiving cytapheresis within 14 days prior to study entry
5)Patients who have allergy to salicylates
6)Patients who have experienced serious adverse effect elicited by mesalazine
7)Patients who have complicated malignant disease
8)Patients who are pregnant or possibly pregnant
9)Patients suspected to remain the effect of intervention in other clinical researches
10)Patients who have any condition that might interfere with study assessments, judged by the investigator.
60
1st name | |
Middle name | |
Last name | Yasuo Suzuki |
Toho University Sakura Medical Center
Gastroenterology Center
564-1, Shimosizu Sakura, Chiba 285-8741, Japan
043-462-8811
1st name | |
Middle name | |
Last name | Yasuo Suzuki |
Toho University Sakura Medical Center
Gastroenterology Center
564-1, Shimosizu Sakura, Chiba 285-8741, Japan
043-462-8811
yasuo-suzuki@sakura.med.toho-u.ac.jp
Toho University Sakura Medical Center
None
Self funding
NO
成田赤十字病院(千葉県)
東京慈恵会医科大学付属柏病院(千葉県)
津田沼中央病院
東葛辻仲病院
千葉大学医学部付属病院(千葉県)
東京歯科大学市川総合病院
セコメディック病院
社会保険船橋中央病院
2013 | Year | 03 | Month | 08 | Day |
Partially published
No longer recruiting
2011 | Year | 03 | Month | 05 | Day |
2011 | Year | 03 | Month | 01 | Day |
2012 | Year | 12 | Month | 01 | Day |
2013 | Year | 01 | Month | 01 | Day |
2013 | Year | 02 | Month | 01 | Day |
2013 | Year | 03 | Month | 01 | Day |
2013 | Year | 03 | Month | 05 | Day |
2013 | Year | 03 | Month | 05 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011906
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |