UMIN-CTR Clinical Trial

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

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)
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Address
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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
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Results Delayed
Results Delay Reason
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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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024935

Research Plan
Registered date	File name

Research case data specifications
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Research case data
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