Unique ID issued by UMIN | UMIN000014838 |
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Receipt number | R000017111 |
Scientific Title | Study on the efficacy of 5ASA oral formula and suppository against relapse of proctitis |
Date of disclosure of the study information | 2014/08/12 |
Last modified on | 2018/08/15 13:07:20 |
Study on the efficacy of 5ASA oral formula and suppository against relapse of proctitis
Oral vs. suppository 5ASA against relapse of proctitis
Study on the efficacy of 5ASA oral formula and suppository against relapse of proctitis
Oral vs. suppository 5ASA against relapse of proctitis
Japan |
proctitis
Gastroenterology |
Others
NO
To compare the efficacy of remission induction in relapsed proctitis between 5ASA suppository and 5ASA oral formula
Efficacy
Exploratory
Pragmatic
Not applicable
improvement in endoscopic Mayo score 4 weeks after the intervention
proportion of patients without relapse of rectal bleeding after 1 year of maintenance therapy
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
NO
Institution is not considered as adjustment factor.
YES
Numbered container method
2
Treatment
Medicine |
asacol 3.6g t.i.d 4 weeks
pentasa suppository 1g/day 4 weeks
20 | years-old | <= |
85 | years-old | >= |
Male and Female
Having been diagnosed as proctitis by colonoscopy more than 6 months before
Having been on maintenance therapy with oral 5ASA (2.4g/day or less), oral sulfasalazine (3g/day or less), sulfasalazine suppository, or 5ASA suppository(1 in two days or less), or no maintenance therapy, which has not been changed for at least 2 months prior to the study entry
Bleeding Mayo score > 0
Given written informed consent
Eendoscopic Mayo score > 0
No active inflammation in area more than 15cm from the anal verge on colonoscopy
Pregnant or nursing female
Patients who received steroids, immunosuppressants, immunomodulators, anti-TNF alpha, or leucocytapheresis within 3 months before the study entry
Those with severe liver or renal dysfunction
Those with a history of hypersensitivity against mesalazine
Those who were regarded inadequate for this study
140
1st name | |
Middle name | |
Last name | Nobuyuki Matsuhashi |
NTT Medical Center Tokyo
Dept of Gastroenterology
5-9-22 Higashigotanda Shinagawa-ku, Tokyo
03-3448-6245
nmatuha-tky@umin.ac.jp
1st name | |
Middle name | |
Last name | Nobuyuki Matsuhashi |
NTT Medical Center Tokyo
Dept of Gastroenterology
5-9-22 Higashigotanda Shinagawa-ku, Tokyo
03-3448-6245
nmatuha-tky@umin.ac.jp
NTT Medical Center Tokyo
none
Self funding
NO
2014 | Year | 08 | Month | 12 | Day |
Unpublished
Terminated
2014 | Year | 08 | Month | 12 | Day |
2014 | Year | 08 | Month | 12 | Day |
2014 | Year | 08 | Month | 12 | Day |
2018 | Year | 08 | Month | 15 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017111
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