UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022006 |
|---|---|
| Receipt number | R000025345 |
| Scientific Title | Potassium-competitive acid blocker versus proton pump inhibitor for the healing effect of gastric ulcer induced by endoscopic submucosal dissection |
| Date of disclosure of the study information | 2016/04/22 |
| Last modified on | 2016/05/05 15:11:08 |
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Basic information
Public title
Potassium-competitive acid blocker versus proton pump inhibitor for the healing effect of gastric ulcer induced by endoscopic submucosal dissection
Acronym
Comparison of vonoprazan and lansoprazole
Scientific Title
Potassium-competitive acid blocker versus proton pump inhibitor for the healing effect of gastric ulcer induced by endoscopic submucosal dissection
Scientific Title:Acronym
Comparison of vonoprazan and lansoprazole
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to compare the healing effect of P-CAB (vonoprazan) and PPI (lansoprazole) on ESD-induced ulcers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoint was to evaluate the shrinking rate of ESD-induced ulcers between vonoprazan (20mg/day) group and lansoprazole (30mg/day) group 28 days after ESD.
Key secondary outcomes
The secondary endpoint was to compare the preventive effect of vonoprazan and lansoprazole for delayed bleeding
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
Patients were prospectively and randomly assigned into either vonoprazan group or lansoprazole group. The day before ESD, patients were admitted. After the ESD,patients in vonoprazan group began to take vonoprazan 20mg daily until the protocol finished. Eight days and 28 days after ESD, patients underwent follow-up EGD and the shrinking rate of the ulcers on day 8th and 28th was evaluated between the 2 groups.
Interventions/Control_2
Patinets in lansoprazole group began to took lansoprazole 30mg daily until the protocol finished.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Thirty consecutive patients, who underwent ESD for early gastric cancer between August 2015 and March 2016 at Sado General Hospital, were enrolled in this study. Patients who had undergone gastric surgery before ESD were not included in this study.
Key exclusion criteria
Those who needed any additional anticancer therapy (surgery and/or chemotherapy) after ESD were excluded.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya Takahashi |
Organization
Niigata University Medical and Dental Hospital, Niigata, Japan
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL
025-223-2207
kazuya911@hotmail.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya Takahashi |
Organization
Niigata University Medical and Dental Hospital, Niigata, Japan
Division name
Division of Gastroenterology and Hepatology
Zip code
Address
757-1, Asahimachidori, Chuo-ku, Niigata-city, Niigata 951-8510, Japan
TEL
025-223-2207
Homepage URL
kazuya911@hotmail.co.jp
Sponsor or person
Institute
Sado general hospital
Institute
Department
Personal name
Funding Source
Organization
not applicable
Organization
Division
Category of Funding Organization
Other
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
| 2016 | Year | 04 | Month | 22 | 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
Our study indicated that lansoprazole was cost-effective and potent enough for the management of ESD ulcers, although vonoprazan is also sufficient.
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 | 08 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 08 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
| 2016 | Year | 05 | Month | 05 | Day |
Date trial data considered complete
| 2016 | Year | 05 | Month | 05 | Day |
Date analysis concluded
| 2016 | Year | 05 | Month | 05 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 04 | Month | 20 | Day |
Last modified on
| 2016 | Year | 05 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025345
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/05/05 | タケキャブ研究計画書.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
| 2016/05/05 | アップロード.xlsx |
