UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027069
Receipt number R000031032
Scientific Title Symptom relief of gastric acid suppressants in patients with reflux esophagitis - Randomized controlled comparative study of vonoprazan and esomeprazole -
Date of disclosure of the study information 2017/04/20
Last modified on 2017/04/19 20:12:05

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Basic information

Public title

Symptom relief of gastric acid suppressants in patients with reflux esophagitis
- Randomized controlled comparative study of vonoprazan and esomeprazole -

Acronym

Symptom relief of gastric acid suppressants in patients with reflux esophagitis

Scientific Title

Symptom relief of gastric acid suppressants in patients with reflux esophagitis
- Randomized controlled comparative study of vonoprazan and esomeprazole -

Scientific Title:Acronym

Symptom relief of gastric acid suppressants in patients with reflux esophagitis

Region

Japan


Condition

Condition

Reflex esophagitis patients

Classification by specialty

Hepato-biliary-pancreatic medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate GERD related symptom relief of vonoprazan and esomeprazole

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

GOS Questionnaire after 84-week treatment

Key secondary outcomes

1:The Change of individual score and the improvement of symptom (heartburn,regurgitation) evaluated using GOS/FSSG after4,8-week treatment
2:The improvement of symptom (epigastric pain, nausea, vomiting) evaluated using GOS/FSSG after 4,8-week treatment
3:Treatment response evaluated by GOS/FSSG after 4,8-week treatment


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Vonoprazan 20mg p.o. once daily, 4weeks,and Vonoprazan 10mg p.o. once daily, 4weeks

Interventions/Control_2

Esomeprazole 20mg p.o. once daily, 8weeks

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 or written sufficient explanation.
2:Patients who were confirmed reflux esophagitis with grade A-D of LA classification at the entry or in the past.
3:Patients who answered score of 4 (moderate problem) or severer in questions about heartburn, Q2 and/or regurgitation, Q3.

Key exclusion criteria

1:Patients with warning signs such as vomiting, gastrointestinal bleeding and sudden weight loss.
2:Patients with confirmed or suspected malignant diseases.
3:Patients with a history of gastrointestinal resection of vagotomy.
4:Patients with a history of irritable bowel syndrome.
5:Patients whose participation in this study would be contraindicated due to complications such as serious hepatic, renal or heart disease.
6:Pregnant patients, possibly pregnant or lactating women.
7:Patients judged as inadequate in participation of this study by their attending physicians.

Target sample size

60


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masahiro Hirano

Organization

Hirano Gastroenterology Clinic

Division name

Gastroenterology

Zip code


Address

2-3029-2,Onuki town, Nobeoka city, Miyazaki prefecture

TEL

0982-26-7070

Email

gihirano@gaea.ocn.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masahiro Hirano

Organization

Hirano Gastroenterology Clinic

Division name

Gastroenterology

Zip code


Address

2-3029-2,Onuki town, Nobeoka city, Miyazaki prefecture

TEL

0982-26-7070

Homepage URL


Email

gihirano@gaea.ocn.ne.jp


Sponsor or person

Institute

Hirano Gastroenterology Clinic

Institute

Department

Personal name



Funding Source

Organization

Hirano 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

平野消化器内科(Hirano Gastroenterology Clinic)


Other administrative information

Date of disclosure of the study information

2017 Year 04 Month 20 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 01 Month 01 Day

Date of IRB


Anticipated trial start date

2017 Year 01 Month 04 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 04 Month 19 Day

Last modified on

2017 Year 04 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031032


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name