UMIN-CTR Clinical Trial

Public title

Symptomatic effect and serum gastrin level after treatment with proton pump
inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker

Acronym

Symptomatic effect and serum gastrin level after treatment with proton pump
inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker

Scientific Title

Symptomatic effect and serum gastrin level after treatment with proton pump
inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker

Scientific Title:Acronym

Symptomatic effect and serum gastrin level after treatment with proton pump
inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker

Region

Japan

Condition

GERD

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The objective of this study was to investigate the effects of Esomeprazole 20 mg once a day for patients with Pcab resistant reflux esophagitis with remnant symptoms even after oral administration of Vonoprazan 20 mg for 4 weeks or more after four weeks of effect on gastrointestinal symptoms Are compared and examined using various scores of FSSG which is a patient self-entry questionnaire as an index.
We will also examine changes in symptoms other than GERD symptoms including safety before and after switching.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

the change in FSSG total score before and 4 weeks after treatment with Esomeprazole

Key secondary outcomes

1. Score change of each of the reflux score and exercise failure score after 2 or 4 weeks evaluated by the FSSG questionnaire
2. Total core change after 2 weeks evaluated by FSSG questionnaire
3. Therapeutic reactivity after 2 or 4 weeks evaluated in the GOS questionnaire
4. Serum gastrin level change before and after esomeprazole administration
5. tolerability during administration of both drugs

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Self control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Esomeprazole 20 mg capsule
Orally administered once a day
for 4 weeks

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1.Patient who gave written consent to study participation by free documentation and verbally enough explanation.
2.Patients aged 20 years and older at 2 years of age
3.Three patients diagnosed as reflux esophagitis.
4. Patients with Pcab resistant reflux esophagitis whose gastrointestinal symptoms remained despite intake of Vonoprazan for 4 weeks or more at the time of registration.
5.Patients with total score of 8 or more in the 5FSSG interview sheet.

Key exclusion criteria

(1) Patients with warning findings such as vomiting subject to endoscopic examination, gastrointestinal bleeding (including findings of hematemesis, venous drainage, anemia, etc.), and rapid weight loss.
(2) Patients with malignant lesions confirmed or suspected of malignant lesions.
(3) A patient with a history of gastrointestinal resection and vagotomy.
(4) Patients with irritable bowel syndrome.
(5) Patients who are difficult to participate in this study due to mergers of severe liver disease, kidney disease, heart disease etc.
(6) Pregnant women, lactating women or lactating women who may be pregnant.
(7) Patients who other doctors judged inappropriate as subjects of this study.

Target sample size

25

Name of lead principal investigator

1st name
Middle name
Last name	Shinichi Ishihara

Organization

Ishihara Gastroenterology Clinic

Division name

Gastroenterology

Zip code

Address

Ikano cho 1852-1,Zentsuji city ,Kagawa prefecture

TEL

0877-63-6677

Email

ccy63890@yahoo.co.jp

Name of contact person

1st name
Middle name
Last name	Shinichi Ishihara

Organization

Ishihara Gastroenterology Clinic

Division name

Gastroenterology

Zip code

Address

Ikano cho 1852-1,Zentsuji city ,Kagawa prefecture

TEL

0877-63-6677

Homepage URL

Email

ccy63890@yahoo.co.jp

Institute

Ishihara Gastroenterology Clinic

Institute

Department

Personal name

Organization

Ishihara Gastroenterology Clinic

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

01

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

05

Month

01

Day

Date of IRB

Anticipated trial start date

2017

Year

07

Month

01

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2018

Year

01

Month

22

Day

Last modified on

2018

Year

01

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035335