![]() |
UMIN-CTR Clinical Trial |
|
![]() |
![]() |
![]() |
![]() |
Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000016835 |
Receipt No. | R000019537 |
Scientific Title | Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection |
Date of disclosure of the study information | 2015/03/18 |
Last modified on | 2017/08/31 |
Basic information | ||
Public title | Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection
|
|
Acronym | Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection | |
Scientific Title | Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection
|
|
Scientific Title:Acronym | Comparison of PPIand P-CAB in the gastric ulcer healing after endoscopic submucosal dissection | |
Region |
|
Condition | ||
Condition | early gastric cancer, gastric adenoma | |
Classification by specialty |
|
|
Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To compare the reduction rate in artificial ulcers after endoscopic submucosal dissection between a PPI group and a P-CAB group at random. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Reduction of the size of the gastric ulcer after ESD |
Key secondary outcomes | Rate of post-operative bleeding |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | YES |
Dynamic allocation | YES |
Institution consideration | Institution is considered as adjustment factor in dynamic allocation. |
Blocking | NO |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
|
|
Interventions/Control_1 | vonoprazan fumarate20mg+rebamipide300mg | |
Interventions/Control_2 | esomeprazole20mg+rebamipide300mg | |
Interventions/Control_3 | ||
Interventions/Control_4 | ||
Interventions/Control_5 | ||
Interventions/Control_6 | ||
Interventions/Control_7 | ||
Interventions/Control_8 | ||
Interventions/Control_9 | ||
Interventions/Control_10 |
Eligibility | ||||
Age-lower limit |
|
|||
Age-upper limit |
|
|||
Gender | Male and Female | |||
Key inclusion criteria | Patients who undergo ESD for gastric cancer or gastric adenoma.
Patients who give a written informed consent. |
|||
Key exclusion criteria | Pregnancy or lactation.
Past history of allergy for the drugs used in this therapy. Patients on some form of antithrombotic therapy or NSAIDs, adrenocorticosteroid. Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction. Patients who are disqualified for the study by physicians. |
|||
Target sample size | 72 |
Research contact person | |||||||
Name of lead principal investigator |
|
||||||
Organization | Yokohama City University Hospital | ||||||
Division name | Gastroenterology | ||||||
Zip code | |||||||
Address | Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan | ||||||
TEL | 0452615656 | ||||||
smaeda@med.yokohama-cu.ac.jp |
Public contact | |||||||
Name of contact person |
|
||||||
Organization | Yokohama City University Hospital | ||||||
Division name | Gastroenterology | ||||||
Zip code | |||||||
Address | Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan | ||||||
TEL | 045-261-5656 | ||||||
Homepage URL | |||||||
t146009d@yokohama-cu.ac.jp |
Sponsor | |
Institute | Yokohama City University Hospital |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Self funding |
Nationality of Funding Organization |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | |
Address | |
Tel | |
Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
Institutions |
Other administrative information | |||||||
Date of disclosure of the study information |
|
Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
URL related to results and publications | |
Number of participants that the trial has enrolled | |
Results | In the healing of artificial ulcer after gastric ESD, both P - CAB and PPI worked well, and no significant difference was found between the differences. |
Results date posted | |
Results Delayed | |
Results Delay Reason | |
Date of the first journal publication of results | |
Baseline Characteristics | |
Participant flow | |
Adverse events | |
Outcome measures | |
Plan to share IPD | |
IPD sharing Plan description |
Progress | |||||||
Recruitment status | Completed | ||||||
Date of protocol fixation |
|
||||||
Date of IRB | |||||||
Anticipated trial start date |
|
||||||
Last follow-up date |
|
||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
|
Other | |
Other related information |
Management information | |||||||
Registered date |
|
||||||
Last modified on |
|
Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019537 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |