UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029032
Receipt number R000033210
Scientific Title Study on the symptom control of gastric acid suppressive drugs in reflux esophagitis patients
Date of disclosure of the study information 2017/09/06
Last modified on 2019/12/13 11:12:34

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Basic information

Public title

Study on the symptom control of gastric acid suppressive drugs in reflux esophagitis patients

Acronym

Study on the recurrent symptom after suspension of therapy with gastric acid suppressive drugs in reflux esophagitis patients

Scientific Title

Study on the symptom control of gastric acid suppressive drugs in reflux esophagitis patients

Scientific Title:Acronym

Study on the recurrent symptom after suspension of therapy with gastric acid suppressive drugs in reflux esophagitis patients

Region

Japan


Condition

Condition

Reflux esophagitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the recurrent symptom at 2 weeks after suspension of therapy with vonoprazan or esomeprazole in patients with reflux esophagitis using Gerd Q score of heartburn and acid regurgitation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Gerd Q total score of heartburn and acid regurgitation

Key secondary outcomes

1. Gerd Q each score of heartburn and acid regurgitation
Degrees of heartburn and acid regurgitation
2. Gerd Q each score of epigastralgia, nausea and vomiting
Degrees of epigastralgia, nausea and vomiting
3. Evaluation of treatment response with Gerd Q


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is 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

Suspension of therapy with vonoprazan

Interventions/Control_2

Suspension of therapy with esomeprazole

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. Patients who have freely provided written informed consent for the participation of this study after the oral and written sufficient explanation
2. Patients diagnosed as having reflux esophagitis by physician, and receiving the therapy with vonoprazan or esomeprazole for 4 weeks or longer
3. Patients who check 0 day a week in GerdQ Q1 and Q2

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 confirmed or suspected malignant lesion
3. Patients with a history of gastrointestinal resection or vagotomy
4. Patients in Irritable Bowel Syndrome
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. Other patients whom the investigator considers unsuitable for admission to the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yasuhiro
Middle name
Last name Mizuno

Organization

Marru-clinic Yokosuka

Division name

Department of Gastroenterology

Zip code

238-0011

Address

Kyoritsu Yonegahama Building 5F, 1-8-7, Yonegahamadori, Yokosuka, Kanagawa, Japan

TEL

+81-46-828-5333

Email

mizunoy3000@gmail.com


Public contact

Name of contact person

1st name Yasuhiro
Middle name
Last name Mizuno

Organization

Marru-clinic Yokosuka

Division name

Department of Gastroenterology

Zip code

238-0011

Address

Kyoritsu Yonegahama Building 5F, 1-8-7, Yonegahamadori, Yokosuka, Kanagawa, Japan

TEL

+81-46-828-5333

Homepage URL


Email

mizunoy3000@gmail.com


Sponsor or person

Institute

Marru-clinic Yokosuka
Department of Gastroenterology

Institute

Department

Personal name



Funding Source

Organization

None
Self funding

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

Marru-clinic Yokosuka

Address

Kyoritsu Yonegahama Building 5F, 1-8-7, Yonegahamadori, Yokosuka, Kanagawa, Japan

Tel

+81-46-828-5333

Email

mizunoy3000@gmail.com


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

2017 Year 09 Month 06 Day


Related information

URL releasing protocol

none

Publication of results

Unpublished


Result

URL related to results and publications

none

Number of participants that the trial has enrolled

30

Results

In the results, between the PCAB (5 cases/30 cases, 33%) and PPI (6 cases/30 cases, 40.0%) groups in the proportion of patients with a positive symptom score of at least 1 point at 2 weeks after discontinuation, there was no statistically significant difference (chi-square test, p = 0.705) . Negative symptom scores were not also statistically significantly different between the PCAB (7 cases, 46%) and PPI (4 cases, 26.7%) groups (chi-square test, p = 0.256).

Results date posted

2019 Year 12 Month 12 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2019 Year 11 Month 29 Day

Baseline Characteristics

Patients diagnosed of GERD between December 2017 and April 2018 at the Marru-clinic Yokosuka, who continued oral administration of PCAB or PPI for more than 4 weeks, and whose symptoms subsided.

Participant flow

Patients were examined for GERDQ scores after cessation of oral administration.

Adverse events

symptoms or abnormal findings were collected

Outcome measures

postitive symptom score, total GERD Q score, negative symptom score, positive impact score

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 08 Month 29 Day

Date of IRB

2017 Year 08 Month 23 Day

Anticipated trial start date

2017 Year 09 Month 11 Day

Last follow-up date

2018 Year 03 Month 09 Day

Date of closure to data entry

2019 Year 02 Month 28 Day

Date trial data considered complete

2019 Year 03 Month 31 Day

Date analysis concluded

2019 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2017 Year 09 Month 06 Day

Last modified on

2019 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033210


Research Plan
Registered date File name
2019/12/12 臨床研究実施計画書.docx

Research case data specifications
Registered date File name

Research case data
Registered date File name