UMIN-CTR Clinical Trial

Unique ID issued by UMIN	UMIN000016637
Receipt number	R000019284
Scientific Title	Study of the improvement effect of potassium competitive acid blocker and proton pump inhibitors on symptoms in patients with reflux esophagitis (RE): 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	2015/02/26
Last modified on	2017/02/27 14:42:14

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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 reflux esophagitis (RE): a randomized comparative study of vonoprazan 20mg vs. rabeprazole 10mg using the time (number of days) to improvement in symptoms as an index

Acronym

Scientific Title

Scientific Title:Acronym

Region

Japan

Condition

patients with reflux esophagitis

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To compare the clinical effect of vonoprazan 20mg/day vs. rabeprazole 10mg/day after 1 week of treatment in patients with reflux esophagitis 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

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 diagnosed endoscopically in the past 12 months with Grade A-D (Los Angeles classification) reflux esophagitis
(4) Patients with 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

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 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 anti-inflammatory 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

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2015 Year 02 Month 26 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

2015 Year 02 Month 20 Day

Date of IRB

Anticipated trial start date

2015 Year 02 Month 26 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

2015 Year 02 Month 25 Day

Last modified on

2017 Year 02 Month 27 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019284