UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028962
Receipt number R000033145
Scientific Title Comparative study of symptom improvement effect of vonoprazan and esomeprazole in patients with reflux esophagitis.
Date of disclosure of the study information 2017/09/01
Last modified on 2017/09/01 17:43:21

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Basic information

Public title

Comparative study of symptom improvement effect of vonoprazan and esomeprazole in patients with reflux esophagitis.

Acronym

Study of symptom improvement effect of gastric secretion inhibitors in patients with reflux esophagitis.

Scientific Title

Comparative study of symptom improvement effect of vonoprazan and esomeprazole in patients with reflux esophagitis.

Scientific Title:Acronym

Study of symptom improvement effect of gastric secretion inhibitors in patients with reflux esophagitis.

Region

Japan


Condition

Condition

Reflex esophagitis

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the clinical symptom improvement effect of Vonoprazan compared with esomeprazole

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The change of total score evaluated using FSSG

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

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

Vonoprazan 20mg oral once a day, 4weeks

Interventions/Control_2

Esomeprazole 20mg oral once a day, 4weeks

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.The patients aged 20 years or older.
2.The patients who are diagnosed as having reflux esophagitis by physician.
3.The patients who have GERD symptom (heartburn or acid regurgitation) at least once a week.

Key exclusion criteria

1.The patients with warning signs such as vomiting, gastrointestinal bleeding and sudden weight loss.
2.The patients with confirmed or suspected malignant diseases.
3.The patients with a history of gastrointestinal resection of vagotomy.
4.The patients with a history of irritable bowel syndrome.
5.The patients whose participation in this study would be contraindicated due to complications such as serious heaptic, renal or heart disease.
6.The Pregnant patients or possibly pregnant patients.
7.The patients prohibited the participant of this study by their attending physicians.
8.The patients who took esomeprazole or vonoprazan within 4 weeks.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tsutomu Masuda

Organization

Ikoma Gastorenteroproctorogy Clinic

Division name

Gastroenterology

Zip code


Address

7-10 Honmachi, Ikoma-shi, Nara

TEL

0743-71-8050

Email

t-masuda@gaia.eonet.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tsutomu Masuda

Organization

Ikoma Gastorenteroproctorogy Clinic

Division name

Gastroenterology

Zip code


Address

7-10 Honmachi, Ikoma-shi, Nara

TEL

0743-71-8050

Homepage URL


Email

t-masuda@gaia.eonet.ne.jp


Sponsor or person

Institute

Ikoma Gastorenteroproctorogy Clinic

Institute

Department

Personal name



Funding Source

Organization

Ikoma Gastorenteroproctorogy 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

2017 Year 09 Month 01 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

Open public recruiting

Date of protocol fixation

2017 Year 05 Month 15 Day

Date of IRB


Anticipated trial start date

2017 Year 06 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

2017 Year 09 Month 01 Day

Last modified on

2017 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033145


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name