UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000016642
Receipt number R000019318
Scientific Title Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer
Date of disclosure of the study information 2015/02/27
Last modified on 2020/07/21 19:29:41

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Basic information

Public title

Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer

Acronym

Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer

Scientific Title

Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer

Scientific Title:Acronym

Effectiveness of Vonoprazan in patients treated with post-ESD gastric ulcer

Region

Japan


Condition

Condition

gastric neoplasm

Classification by specialty

Medicine in general

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

We aimed to evaluate the effectiveness of Vonoprazan in patients with post-ESD gastric ulcer

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

improvement of post-operative gastric ulcer

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

Numbered container method


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

We evalate improvement of post-operative gastric ulcer for pationts treated with endoscopic submucosal dissection for two months.

Interventions/Control_2

We evalate improvement of post-operative gastric ulcer for pationts treated with endoscopic submucosal dissection for two months.

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

Patients with gastric tumors whom concents has been obtained to participate in this study, which has been approved by the ethics committee

Key exclusion criteria

Remnant stomach, administration of antithrombotic agents, non-steroidal anti-inflammatory drugs and steroids, occurrence of complication during ESD, allergy to lansoprazole or vonoprazan, and unwillingness to participate in the study.

Target sample size

180


Research contact person

Name of lead principal investigator

1st name Ryuta
Middle name
Last name Takenaka

Organization

Tsuyama Chuo Hospital

Division name

Department of Gastroenterology

Zip code

708-0841

Address

1756 Kawasaki-Tsuyama-city, Okayama

TEL

0868-21-8111

Email

daicawai@yahoo.co.jp


Public contact

Name of contact person

1st name Daisuke
Middle name
Last name Kawai

Organization

Tsuyama Chuo Hospital

Division name

Department of Gastroenterology

Zip code

708-0841

Address

1756 Kwasaki-Tsuyama-city, Okayama

TEL

0868-21-8111

Homepage URL


Email

daicawai@yahoo.co.jp


Sponsor or person

Institute

Tsuyama Chuo Hospital

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

Tsuyama Chuo Hospital

Address

1756, Kawasaki, Tsuyama City

Tel

0878-21-8111

Email

daicawai@yahoo.co.jp


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 02 Month 27 Day


Related information

URL releasing protocol

A prospective, randomized controlled trial of vonoprazan versus lansoprazole

Publication of results

Partially published


Result

URL related to results and publications

Vonoprazan is not superior to lansoprazole in the healing of artificial gastric ulcer after ESD.

Number of participants that the trial has enrolled

168

Results

A total of 168 patients were analyzed. The 4-week healing rate for artificial ulcer was not significantly higher in Vonoprazan group versus group Lansoprazole (17/85, 20.0% vs. 14/83, 16.9%, respectively). In addition, there were no significant differences between the 4-week shrinkage rates between the two groups.

Results date posted

2020 Year 06 Month 25 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

A total of 168 patients were analyzed.

Participant flow

Patients with gastric tumors were randomly
assigned to the vonoprazan group or lansoprazole group after ESD.

Adverse events

Postoperative bleeding occurred in none of the patients in group V and three in group L. One patient in group V presented delayed perforation 2 days after ESD.

Outcome measures

The 4-week healing rate for artificial ulcer
and the 4-week shrinkage rates

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2015 Year 02 Month 25 Day

Date of IRB

2015 Year 02 Month 01 Day

Anticipated trial start date

2015 Year 03 Month 01 Day

Last follow-up date

2017 Year 03 Month 31 Day

Date of closure to data entry

2017 Year 03 Month 31 Day

Date trial data considered complete

2017 Year 03 Month 31 Day

Date analysis concluded

2017 Year 05 Month 31 Day


Other

Other related information



Management information

Registered date

2015 Year 02 Month 26 Day

Last modified on

2020 Year 07 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019318


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name