UMIN-CTR Clinical Trial

Public title

Study of the improvement effect of the Maintenance treatment of Vonoprazan and Esomeprazole on symptoms in patients with gastro-esophageal reflux disease (GERD)

Acronym

Study of the improvement effect of the Maintenance treatment of Vonoprazan and Esomeprazole on symptoms in patients with gastro-esophageal reflux disease (GERD)

Scientific Title

Study of the improvement effect of the Maintenance treatment of Vonoprazan and Esomeprazole on symptoms in patients with gastro-esophageal reflux disease (GERD)

Scientific Title:Acronym

Study of the improvement effect of the Maintenance treatment of Vonoprazan and Esomeprazole on symptoms in patients with gastro-esophageal reflux disease (GERD)

Region

Japan

Condition

gastro-esophageal reflux disease (GERD)

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study was to administer Vonoprazan 20 mg once a day for patients with gastroesophageal reflux disease for 2 weeks as an initial treatment and then to administer Vonoprazan 10 mg once a day or Esomeprazole 20 mg once a day as maintenance therapy and to clinically evaluate the clinical effect after 2 weeks The GerdQ score which is a patient self-entry questionnaire as an index is compared as an indicator.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

the change in GerdQ total score before and 2,4 weeks after treatment with Vonoprazan and Esomeprazole

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Vonoprazan 20mg orally once a day for two weeks,continued by Vonoprazan 10mg orally once a day for two weeks

Interventions/Control_2

Vonoprazan 20mg orally once a day for two weeks,continued by Esomeprazole 20mg orally once a day for two weeks

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) Patients who have freely given written consent to participating in the study after receiving a full explanation (written and oral) of the study.
2) Patients who had 8 or more of GerdQ score before the registration
3)Patients who were diagnosed with GERD

Key exclusion criteria

1)Patients with warning signs such as
vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia),and sudden weight loss
2)Patients with a confirmed, or suspected, malignant lesion
3)Patients with a history of gastrointestinal resection or vagotomy
4)The patient with Irritable Bowel Syndrome (IBS)
5)Patients whose participation in this study would be contraindicated due to
complications such as serious hepatic
disease, renal disease, or cardiac disease.
6)Women who are pregnant or who may possibly be pregnant, and lactating mothers
7)treated with atazanavir sulfate, Rilpivirine Hydrochloride
8)Other patients whom the investigator
considers unsuitable for admission to the
study

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Koji Nagaike

Organization

Suita municipal hospital

Division name

Gastroenterology

Zip code

Address

2-13-20, Katayamacho, Suita, Osaka, 564-0082, Japan

TEL

06-6387-3311

Email

nagaike7477@mhp.suita.osaka.jp

Name of contact person

1st name
Middle name
Last name	Koji Nagaike

Organization

Suita municipal hospital

Division name

Gastroenterology

Zip code

Address

2-13-20, Katayamacho, Suita, Osaka, 564-0082, Japan

TEL

06-6387-3311

Homepage URL

Email

nagaike7477@mhp.suita.osaka.jp

Institute

Suita municipal hospital

Institute

Department

Personal name

Organization

Suita municipal hospital

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

05

Month

14

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

Preinitiation

Date of protocol fixation

2018

Year

03

Month

01

Day

Date of IRB

Anticipated trial start date

2018

Year

05

Month

14

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

05

Month

07

Day

Last modified on

2018

Year

05

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037049