UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study of symptom improvement effect of gastric acid suppressive drugs in reflux esophagitis patients with type 2 diabetes mellitus -a randomized comparative study of vonoprazan vs esomeprazole -
Title of the study (Brief title)	Study of symptom improvement effect of gastric acid suppressive drugs in reflux esophagitis patients with type 2 diabetes mellitus -a randomized comparative study of vonoprazan vs esomeprazole -
Region	Japan

Condition
Condition	Reflux esophagitis with type 2 diabetes mellitus
Classification by specialty	Medicine in general
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the clinical effect of vonoprazan 20mg/day vs. esomeprazole 20mg/day after 4 weeks of treatment in patients with reflux esophagitis with type 2 diabetes mellitus using GerdQ
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Treatment response rate in the GerdQ after 4 weeks of treatment. Comparison of the effects of treatment between groups.
Key secondary outcomes	1) Complete resolution rate in the GerdQ(heartburn, regurgitation) after 4 weeks of treatment. Comparison of the effects of treatment between groups. 2) Change of GSRS score (average score, reflux syndrome, abdominal pain, constipation syndrome, diarrhea syndrome, indigestion syndrome) at 4 weeks after treatment. 3) Rate of change GSRS score (average score, reflux syndrome, abdominal pain, constipation syndrome, diarrhea syndrome, indigestion syndrome) . Comparison of the effects of treatment between groups. 4)Sub analysis of treatment response by patient demographics(including drugs, gender, age, BMI, Neuropathy). 5)Adverse event

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 20mg orally once a day for 4 weeks
Interventions/Control_2	Esomeprazole 20mg orally once a day for 4 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	80 years-old >
Gender	Male and Female
Key inclusion criteria	1)Patients aged 20-79 years at the time of providing informed consent 2)Patients who are diagnosed as having reflux esophagitis by physician 3)Patients who scored 8 or above score in GerdQ
Key exclusion criteria	1)The patients with warning signs such as vomiting, gastrointestinal bleeding and sudden weight loss 2)The patients with confirmed or suspected malignant disease 3)The patients with a history of gastrointestinal resection or vagotomy 4)The patients with a history of irritable bowel syndrome 5)The patients whose participation in this study would be contraindicated due to complications such as serious hepatic, renal or heart disease 6)The pregnant patients or possibly pregnant patients 7)Patients unsuited for this study at a physician's discretion 8)Current treatment with gastric secretion inhibitors 9)Type 1 diabetes mellitus
Target sample size	40

Research contact person
Name of lead principal investigator	Takanori Kudo
Organization	Hachinohe City Hospital
Division name	Department of Endocrinology and Diabetes
Address	Tamukai aza bishamontaira 1, Hachinohe, Aomori
TEL	0178-72-5111
Email	t-ku-do@pb3.so-net.ne.jp

Public contact
Name of contact person	Takanori Kudo
Organization	Hachinohe City Hospital
Division name	Department of Endocrinology and Diabetes
Address	Tamukai aza bishamontaira 1, Hachinohe, Aomori
TEL	0178-72-5111
Homepage URL
Email	t-ku-do@pb3.so-net.ne.jp

Sponsor
Institute	Hachinohe City Hospital Department of Endocrinology and Diabetes
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)

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	八戸市立市民病院（青森県）

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 01 Month 10 Day
Anticipated trial start date	2017 Year 03 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 05 Day
Last modified on	2018 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030339