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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name