Unique ID issued by UMIN | UMIN000031564 |
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Receipt number | R000036039 |
Scientific Title | Non-inferiority study of P-CAB for Cure of Ulcer Resected by ESD |
Date of disclosure of the study information | 2018/03/05 |
Last modified on | 2023/04/13 09:07:33 |
Non-inferiority study of P-CAB for Cure of Ulcer Resected by ESD
P-CURE STUDY
Non-inferiority study of P-CAB for Cure of Ulcer Resected by ESD
P-CURE STUDY
Japan |
early gastric cancer or gastric adenoma
Gastroenterology |
Malignancy
NO
To confirm the non-inferiority of 3 weeks treatment of
Bonopurazan for closure of artificial ulcer after gastric ESD compared to 8 weeks treatment of Bonopurazan.
Efficacy
Proportion of complete closure of post ESD ulcer at 24 weeks after gastric ESD.
1) Proportion of bleeding within 3 weeks after gastric ESD.
2) Proportion of bleeding more than 3 weeks after gastric ESD.
3) Proportion of perforation within 3 weeks after gastric ESD.
4) Proportion of perforation more than 3 weeks after gastric ESD.
5) Proportion of complete closure of post ESD ulcer at 8 weeks after gastric ESD.
6) Status of post ESD ulcer (evaluated based on Sakita Miwa classification) at 8 and 24 weeks after ESD.
7) Medical care cost.
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Dose comparison
YES
2
Treatment
Medicine |
Included subjects take Bonoprazan 20mg per day for 21 days.
Included subjects take Bonoprazan 20mg per day for 56 days.
20 | years-old | <= |
85 | years-old | >= |
Male and Female
Patients aged 20-85 undergoing gastric ESD for early gastric cancer or gastric adenoma.
1) Patients with past history of surgery for upper GI tract.
2) Patients with eGFR<30 or on hemodialysis.
3) Patients with uncompensated liver cirrhosis.
4) Patients with severe bleeding tendency.
5) Patients taking systemic NSAIDs or steroid.
6) Patients taking anti-platelet or coagulant drugs.
7) Patients taking PPI or P-CAB continuously at the time of registry.
8) Patients with perforation during ESD.
9) Patients not fulfilling curative criteria by ESD.
10) Patients taking Atazanavir or Rirupibirin.
11) Patients who attending physicians consider to be inappropriate due to other reasons mentioned above
300
1st name | Takanori |
Middle name | |
Last name | Kanai |
Keio University School of Medicine
Division of Gastroenterology and Hepatology, Department of Internal Medicine
160-8582
35, Shinanomachi, Shinjuku-ku, Tokyo
03-5363-3437
takagast@z2.keio.jp
1st name | Motohiko |
Middle name | |
Last name | Kato |
Keio University School of Medicine
Division of Gastroenterology and Hepatology, Department of Internal Medicine
160-8582
35, Shinanomachi, Shinjuku-ku, Tokyo
03-5363-3437
moto28hiko@icloud.com
Keio University School of Medicine
Keio University School of Medicine
Self funding
Keio University School of Medicine
35, Shinanomachi, Shinjuku-ku, Tokyo
03-3353-1211
med-rinri-jimu@adst.keio.ac.jp
NO
2018 | Year | 03 | Month | 05 | Day |
Unpublished
Main results already published
2018 | Year | 01 | Month | 22 | Day |
2018 | Year | 02 | Month | 23 | Day |
2018 | Year | 03 | Month | 05 | Day |
2021 | Year | 01 | Month | 04 | Day |
2018 | Year | 03 | Month | 04 | Day |
2023 | Year | 04 | Month | 13 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036039
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