UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021753 |
|---|---|
| Receipt number | 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 07:09:59 |
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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
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
sakurai@s3.kcn-tv.ne.jp
Sponsor or person
Institute
Hattori clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025085
