UMIN-CTR Clinical Trial

Basic information
Public title	A randomized controlled trial comparing PCAB and PPI therapy for Los Angeles classification Grade C/D reflux esophagitis patient
Acronym	RCT comparing PCAB and PPI for reflux esophagitis
Scientific Title	A randomized controlled trial comparing PCAB and PPI therapy for Los Angeles classification Grade C/D reflux esophagitis patient
Scientific Title:Acronym	RCT comparing PCAB and PPI for reflux esophagitis
Region	Japan

Condition
Condition	Reflux esophagitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess the superiority of PCAB therapy compared to PPI therapy for Los Angeles classification Grade C/D severe reflux esophagitis patient
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Endoscopic cure rate :a rate becoming Las Angeles classification grade M or N.
Key secondary outcomes	Subjective symptoms disappearance rate :Using questionnaire for GERD symptom: Frequency Scale for the Symptoms of GERD (FSSG, F-scale), the rate is defined as (pre F-scale score - post F-scale score)/(pre F-scale score)*100. F-scale of pre and post 4 weeks and 8 weeks is used.

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	PCAB: Vonoprazan 20mg/day 8 weeks
Interventions/Control_2	PPI: Rabeprazole 10mg/day 8 weeks or Esomeprazole 20mg/day 8 weeks
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)A patient who was endoscopically diagnosed as Los Angeles classification Grade C/D severe reflux esophagitis. (2)A patient who have treatment history of PPI or PCAB. (3)A patient who is ambulatory and who can answer the questionnaire. (4)A patient who give a written informed consent.
Key exclusion criteria	(1)A patient with history of gastrectomy which may cause regurgitation of bile acid or pancreatic juice. (2)A patient who use PPI or H2RA already. (3)A patient with pregnancy. (4)A patient with lactation. (5)Past history of allergy for the drug used in this study. (6)Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. (7)A patient who is disqualified for the study by physicians.
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shin Maeda
Organization	Yokohama City University Hospital
Division name	Gastroenterology
Zip code
Address	Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL	045-787-2326
Email	smaeda@med.yokohama-cu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Toshihide Tamura
Organization	Yokohama City University Hospital
Division name	Gastroenterology
Zip code
Address	Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan
TEL	045-787-2326
Homepage URL
Email	Tamura.Toshihide@gmail.com

Sponsor
Institute	Yokohama City University (Basic research expenditures)
Institute
Department

Funding Source
Organization	Yokohama City University (Basic research expenditures)
Organization
Division
Category of Funding Organization	Other
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	2018 Year 03 Month 09 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	2016 Year 01 Month 21 Day
Date of IRB
Anticipated trial start date	2017 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	2018 Year 03 Month 08 Day
Last modified on	2018 Year 03 Month 08 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036110

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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