UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030941
Receipt number R000035335
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
Date of disclosure of the study information 2018/01/23
Last modified on 2018/01/22 22:24:04

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Basic information

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

Condition

GERD

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

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


Assessment

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


Base

Study type

Interventional


Study design

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



Intervention

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



Eligibility

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


Research contact person

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


Public contact

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


Sponsor or person

Institute

Ishihara Gastroenterology Clinic

Institute

Department

Personal name



Funding Source

Organization

Ishihara Gastroenterology Clinic

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

2018 Year 01 Month 23 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

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

Other related information



Management 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name