UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017386 |
|---|---|
| Receipt number | R000020176 |
| Scientific Title | A prospective randomized trial of potassium competitive acid blocker vs proton pump inhibitors on effect of ulcer healing after endoscopic submucosal dissection of gastric neoplasia |
| Date of disclosure of the study information | 2015/05/02 |
| Last modified on | 2016/06/01 09:11:51 |
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Basic information
Public title
A prospective randomized trial of potassium competitive acid blocker vs proton pump inhibitors on effect of ulcer healing after endoscopic submucosal dissection of gastric neoplasia
Acronym
Comparison of P-CAB and PPI on effect of ulcer healing after endoscopic submucosal dissection of gastric neoplasia
Scientific Title
A prospective randomized trial of potassium competitive acid blocker vs proton pump inhibitors on effect of ulcer healing after endoscopic submucosal dissection of gastric neoplasia
Scientific Title:Acronym
Comparison of P-CAB and PPI on effect of ulcer healing after endoscopic submucosal dissection of gastric neoplasia
Region
| Japan |
Condition
Condition
Patients with gastric neoplasia (gastric adenoma, early gastric cancer)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of vonoprazan fumarate 20mg/day and rabeprazole 10mg/day on ulcer healing after endoscopic submucosal dissection of gastric neoplasia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastric ulcer stage and ulcer size reduction rate after 4 weeks treatment
Key secondary outcomes
Rate of post-operative bleeding
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Vonoprazan (Takecab) 20mg orally once a day in the morning
Interventions/Control_2
Rabeprazole (Pariet) 10mg orally once a day in the morning
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who undergo ESD for early gastric cancer or gastric adenoma.
2.Patients who give a written informed consent.
Key exclusion criteria
1.Pregnancy or lactation.
2.Past history of allergy for the drugs used in this therapy.
3.Patients on some form of antithrombotic therapy or NSAIDs, adrenocorticosteroid.
4.Severe liver dysfunction, Severe renal dysfunction, Severe heart dysfunction.
5.Patients who are disqualified for the study by physicians.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroya Ueyama |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1 Hongo, Bunkyo-Ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
psyro@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroya Ueyama |
Organization
Juntendo University School of Medicine
Division name
Department of Gastroenterology
Zip code
Address
2-1-1 Hongo, Bunkyo-Ku, Tokyo 113-8421, Japan
TEL
03-3813-3111
Homepage URL
psyro@juntendo.ac.jp
Sponsor or person
Institute
Department of Gastroenterology, Juntendo University School of Medicine, Tokyo, Japan
Institute
Department
Personal name
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
| 2015 | Year | 05 | Month | 02 | Day |
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
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
| 2015 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 07 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2016 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020176
