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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000021753
Receipt No. R000025085
Scientific Title Comparative study of Potassium Competitive acid blocker (P-CAB) and Classic proton pomp inhibitor in clinical effectiveness for gastro-esophageal reflux symptoms :Randomized Comparative study of venoprazan and esomeprazole
Date of disclosure of the study information 2016/04/02
Last modified on 2018/04/24

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Basic information
Public title Comparative study of Potassium Competitive acid blocker (P-CAB) and Classic proton pomp inhibitor in clinical effectiveness for gastro-esophageal reflux symptoms :Randomized Comparative study of venoprazan and esomeprazole
Acronym Comparative study of venoprazan and esomeprazol in clinical effectiveness for gastro-esophageal reflux symptoms.
Scientific Title Comparative study of Potassium Competitive acid blocker (P-CAB) and Classic proton pomp inhibitor in clinical effectiveness for gastro-esophageal reflux symptoms :Randomized Comparative study of venoprazan and esomeprazole
Scientific Title:Acronym Comparative study of venoprazan and esomeprazol in clinical effectiveness for gastro-esophageal reflux symptoms.
Region
Japan

Condition
Condition Patients of gastro-esophageal reflux symptoms
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We evaluate the clinical effectiveness of P-CAB compared with classical PPI in GERD patients, who are administered venoprazan 20mg/day or esomeprazole 20mg/day.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes The clinical improvement of GERD symptoms (heartburn, acid reflux) evaluated using self-assessment interview sheet, GerdQ, 4 weeks after treatment.
Key secondary outcomes i) The early efficacy of medication, on 1,3,7 day after treatment.
ii) The incidence of side effects.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are 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 oral once a day in the evning, 4weeks
Interventions/Control_2 Esomeprazole 20mg oral once a day in the evning, 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

Not applicable
Gender Male and Female
Key inclusion criteria i) The patients who have freely provided written informed consent for the participation of this study after the oral or written sufficient explanation.
ii) The patients with heartburn and/or acid reflux during 2-3days/week or 4-7days/week in GerdQ.
Key exclusion criteria i) The patients with warning signs such as vomiting, gastrointestinal bleeding and sudden weight loss.
ii) The patients with confirmed or suspected malignant diseases.
iii) The patients with a history of gastrointestinal resection of vagotomy.
iv) The patients with a history of irritable bowel syndrome.
v) The patients whose participation in this study would be contraindicated due to complications such as serious heaptic, renal or heart disease.
vi) The Pregnant patients or possibly pregnant patients.
vii) The patients prohibited the participant of this study by their attending physicians.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouichi Sakurai
Organization Hattori clinic
Division name Hattori clinic
Zip code
Address 2-12-35 Shinmachi, Tyuuouku, Kumamoto City, Kumamoto 860-0047
TEL 096-325-2300
Email sakurai@s3.kcn-tv.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kouichi Sakurai
Organization Hattori clinic
Division name Hattori clinic
Zip code
Address 2-12-35 Shinmachi, Tyuuouku, Kumamoto City, Kumamoto 860-0047
TEL 096-325-2300
Homepage URL
Email sakurai@s3.kcn-tv.ne.jp

Sponsor
Institute Hattori clinic
Institute
Department

Funding Source
Organization others
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 熊本服部胃腸科

Other administrative information
Date of disclosure of the study information
2016 Year 04 Month 02 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 02 Month 16 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 02 Day
Last follow-up date
2017 Year 07 Month 31 Day
Date of closure to data entry
2017 Year 07 Month 31 Day
Date trial data considered complete
2017 Year 07 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 04 Month 02 Day
Last modified on
2018 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025085

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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