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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026407
Receipt No. R000030339
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 -
Date of disclosure of the study information 2017/03/06
Last modified on 2018/09/11

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Basic information
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
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
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

Public contact
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

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)

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 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

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 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
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/ctr_e/ctr_view.cgi?recptno=R000030339

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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