UMIN-CTR Clinical Trial

Public 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 -

Acronym

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 -

Scientific 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 -

Scientific Title:Acronym

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

Reflux esophagitis with type 2 diabetes mellitus

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Takanori Kudo

Organization

Hachinohe City Hospital

Division name

Department of Endocrinology and Diabetes

Zip code

Address

Tamukai aza bishamontaira 1, Hachinohe, Aomori

TEL

0178-72-5111

Email

t-ku-do@pb3.so-net.ne.jp

Name of contact person

1st name
Middle name
Last name	Takanori Kudo

Organization

Hachinohe City Hospital

Division name

Department of Endocrinology and Diabetes

Zip code

Address

Tamukai aza bishamontaira 1, Hachinohe, Aomori

TEL

0178-72-5111

Homepage URL

Email

t-ku-do@pb3.so-net.ne.jp

Institute

Hachinohe City Hospital Department of Endocrinology and Diabetes

Institute

Department

Personal name

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

八戸市立市民病院（青森県）

Date of disclosure of the study information

2017

Year

03

Month

06

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

01

Month

10

Day

Date of IRB

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

Other related information

Registered date

2017

Year

03

Month

05

Day

Last modified on

2018

Year

09

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030339