UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016687 |
|---|---|
| Receipt number | R000019351 |
| Scientific Title | Comparison of the healing effect of Vonoprazan and Lansoprazole in ulcer after gastric endoscopic submucosal dissection: A prospective, randomized controlled trial |
| Date of disclosure of the study information | 2015/03/02 |
| Last modified on | 2017/11/25 15:46:14 |
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Basic information
Public title
Comparison of the healing effect of Vonoprazan and Lansoprazole in ulcer after gastric endoscopic submucosal dissection: A prospective, randomized controlled trial
Acronym
Vonoprazan ESD study
Scientific Title
Comparison of the healing effect of Vonoprazan and Lansoprazole in ulcer after gastric endoscopic submucosal dissection: A prospective, randomized controlled trial
Scientific Title:Acronym
Vonoprazan ESD study
Region
| Japan |
Condition
Condition
gastric adenoma, early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
comparison of Vonoprazan Fumarate and Lansoprazole for efficacy and safety on four and eight weeks administration after ESD of gastric tumor
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gastric ulcer healing rate of post-ESD ulcers after four and eight weeks of gastric ESD
Key secondary outcomes
postoperative bleeding rate after four and eight weeks of gastric ESD
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are 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 Fumarate
Interventions/Control_2
Lansoprazole
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
gastric tumor which meet indication of Gastric Cancer Treatment Guidelines 2014
Key exclusion criteria
1) Patients with difficulty in drug dosing or endoscope insertion due to a stricture or deformity in the upper gastrointestinal tract
2) Patients with an active malignant tumor or other serious systemic complications
3) Patients concurrently treated with an antithrombotic drug
4) Patients with an active ulcer
5) Patients having a problem with their hemostatic ability
6) Patients with a serious complication (heart failure, renal failure, liver failure, respiratory failure)
7) Patients undergoing dialysis
8) Patients with a history of allergy to the investigational product
9) Patients treated with atazanavir sulfate (Reyataz) or rilpivirine hydrochloride (Edurant)
10) Patients in pregnancy or lactation
11) Having a previous history of irradiation to the upper abdomen
12) Scheduled to concurrently receive endoscopic therapy for both esophageal and duodenal lesions
13) Having a history of enrollment in this trial
14) Patients whose consent to participate in this clinical study has not been obtained
15) Other patients judged to be inappropriate as a subject by the principal investigator or a subinvestigator
Target sample size
124
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Higuchi Kazuhide |
Organization
Osaka Medical College
Division name
Second Department of Internal Medicine
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
TEL
072-683-1221
higuchi@poh.osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihisa Takeuchi |
Organization
Osaka Medical College
Division name
Second Department of Internal Medicine
Zip code
Address
2-7 Daigaku-machi, Takatsuki, Osaka 569-8686, Japan
TEL
072-683-1221
Homepage URL
in2097@poh.osaka-med.ac.jp
Sponsor or person
Institute
Osaka Medical College
Institute
Department
Personal name
Funding Source
Organization
Osaka Medical College, Second Department of Internal Medicine
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 | 03 | 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 | 03 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 02 | Day |
Last modified on
| 2017 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019351
