UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021621
Receipt number R000024935
Scientific Title Study of the improvement effect of potassium competitive acid blocker and proton pump inhibitors on symptoms in patients with gastro-esophageal reflux disease (GERD): a randomized comparative study of vonoprazan 20mg vs. rabeprazole 10mg using the time (number of days) to improvement in symptoms as an index
Date of disclosure of the study information 2016/04/01
Last modified on 2016/03/26 10:06:34

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Basic information

Public title

Study of the improvement effect of
potassium competitive acid blocker and
proton pump inhibitors on symptoms in
patients with gastro-esophageal reflux disease (GERD): a randomized comparative study of vonoprazan 20mg vs. rabeprazole 10mg using the time (number of days) to improvement in symptoms as an index

Acronym

Study of the improvement effect of
potassium competitive acid blocker and
proton pump inhibitors on symptoms in
patients with gastro-esophageal reflux disease (GERD): a randomized comparative study of vonoprazan 20mg vs. rabeprazole 10mg

Scientific Title

Study of the improvement effect of
potassium competitive acid blocker and
proton pump inhibitors on symptoms in
patients with gastro-esophageal reflux disease (GERD): a randomized comparative study of vonoprazan 20mg vs. rabeprazole 10mg using the time (number of days) to improvement in symptoms as an index

Scientific Title:Acronym

Study of the improvement effect of
potassium competitive acid blocker and
proton pump inhibitors on symptoms in
patients with gastro-esophageal reflux disease (GERD): a randomized comparative study of vonoprazan 20mg vs. rabeprazole 10mg

Region

Japan


Condition

Condition

gastro-esophageal reflux disease (GERD)

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare the clinical effect of vonoprazan
20mg/day vs. rabeprazole 10mg/day after 1 week of treatment in patients with gastro-esophageal reflux disease (GERD) using the time (number of days) to improvement in reflux symptoms as an index

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time (number of days) to improvement in reflux symptoms after 1 week of treatment

Key secondary outcomes

i Change in reflux symptom score after
treatment
ii. Improvement rates in reflux symptoms
after 2 and 4 weeks of treatment
iii. Frequency of heartburn, acid regurgitation
(sensation of gastric acid reflux), stomach
pain, heavy stomach feeling, early satiety,
nausea, burping, and bloating in subjects prior
to treatment assignment
iv. Improvement rate in individual symptoms
after 2 and 4 weeks of treatment
v. Improvement rate in overall symptoms
after 2 and 4 weeks of treatment
vi. Factors such as patient background and
morbidity period which affect change in score
after treatment


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 (Takecab) 20mg orally once a day in the morning

Interventions/Control_2

Rabeprazole (Pariet) 10mg orally once a day in the morning

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 given written
consent to participating in the study after
receiving a full explanation (written and oral) of the study.
(2) Patients of either sex who are at least 20 years of age.
(3) Patients with FSSG>7 and a Global Overall Severity (GOS) score of 4 troublesome to a moderate degree) for heartburn and/or acid regurgitation (sensation of gastric acid reflux) in the Epigastric Symptom Questionnaire
(4) Patients diagnosed endoscopically in the
past 6 months with Grade A-D (Los Angeles
classification) reflux esophagitis

Key exclusion criteria

(1)Patients with a history of gastrointestinal resection or vagotomy
(2)Patients with warning signs such as
vomiting, gastrointestinal bleeding (including findings of hematemesis, melena, and anemia),and sudden weight loss
(3)Patients with peptic ulcer (except those in scarring stage)
(4)Patients with a history of, or who currently have, any of the following diseases Zollinger-Ellison syndrome Inflammatory Bowel Disease (IBD) Irritable Bowel Syndrome (IBS) Esophageal stricture
Esophageal achalasia Malabsorption Cerebrovascular disorders such as cerebral
hemorrhage and cerebral infarction
(5)Patients whose participation in this study would be contraindicated due to
complications such as serious hepatic
disease, renal disease, or cardiac disease.
(6)Patients with a confirmed, or suspected,
malignant lesion
(7)Women who are pregnant or who may possibly be pregnant, and lactating mothers
(8)Patients who require continued treatment
with drugs (atazanavir sulfate, diazepam,
phenytoin, warfarin, tacrolimus hydrate,
digoxin, methyldigoxin, itraconazole, gefitinib, voriconazole, and antacids containing aluminium hydroxide gel and magnesium hydroxide) which may interact with the study drugs
(9)Patients receiving treatment with potassium competitive acid blocker, proton
pump inhibitors, H2-receptor antagonists,
prokinetic agents, gastric mucosa protective
agents, anticholinergics, antacids,
antidepressants, antianxiety agents, antidiabetic drugs, steroids (excluding
external preparations), non-steroid antiinflammatory drugs (NSAIDs), aspirin
preparations including low-dose aspirin
and/or bisphosphonate drugs. However,
patients who discontinue using these drugs
for at least 1 week prior to the symptom
survey or switch to another treatment, may
enrol in the study.
(10)Other patients whom the investigator
considers unsuitable for admission to the
study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Daisuke Asaoka

Organization

Juntendo University School of Medicine, Tokyo, Japan

Division name

Department of Gastroenterology

Zip code


Address

2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

+81338133111

Email

daisuke@juntendo.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Daisuke Asaoka

Organization

Juntendo University School of Medicine, Tokyo, Japan

Division name

Department of Gastroenterology

Zip code


Address

2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan

TEL

+81338133111

Homepage URL


Email

daisuke@juntendo.ac.jp


Sponsor or person

Institute

Department of Gastroenterology, Juntendo
University School of Medicine, Tokyo, Japan

Institute

Department

Personal name



Funding Source

Organization

None

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

2016 Year 04 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

Preinitiation

Date of protocol fixation

2016 Year 03 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 04 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

2016 Year 03 Month 26 Day

Last modified on

2016 Year 03 Month 26 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024935


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name