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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028502
Receipt No. R000032552
Scientific Title Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients -Randomized controlled comparative test of vonoprazan and esomeprazole-
Date of disclosure of the study information 2017/08/04
Last modified on 2019/06/04

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Basic information
Public title Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients
-Randomized controlled comparative test of vonoprazan and esomeprazole-
Acronym Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients
Scientific Title Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients
-Randomized controlled comparative test of vonoprazan and esomeprazole-
Scientific Title:Acronym Study of the symptom improvement effect of gastric acid secretion inhibitors for refluxe esophagitis patients
Region
Japan

Condition
Condition Reflux esophagitis patients
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The symptom improvement effect and endoscopic improvement of gastric acid secretion inhibitors for reflux esophagitis patients
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Consideration of the symptom improvement value using the interview sheet after4,8 week treatment and the endoscopic improvement effect of after 8 week treatment
Key secondary outcomes The safety value of the treatment

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Vonopurazan 20mg P.o.once daily,8weeks
Interventions/Control_2 Esomeprazole 20mg P.o.once daily,8weeks
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 1.Patients who have freely provided written informed consent for the participation of this study after the oral or written sufficient explanation.
2.Patients who were confirmed reflux esophagitis with grade A-D of LA classification at the entry.
Key exclusion criteria 1.Patients with a history of gastrointestinal resection or vagotomy.
2.Patients with confirmed or susupected malignant disease.
3.Pregnancy or lactation.
4.Past history of allergy for the drugs used in this therapy.
5.Ptients with sever liver dysfunction,sever renal dysfunction,sever hert dysfunction.
6.Ptients who are disqualifid for the study by physicians.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Syuji Inoue
Organization National Hospital Organization National Kochi Hospital
Division name gastroenterology
Zip code
Address 1-2-25, Asakuranishimachi, Kochi, 780-8077, japan
TEL 088-844-3111
Email inouesh@kochi2.hosp.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Syuji Inoue/Sizuka Eguthi
Organization National Hospital Organization National Kochi Hospital
Division name gastroenterology
Zip code
Address 1-2-25, Asakuranishimachi, Kochi, 780-8077, japan
TEL 088-844-3111
Homepage URL
Email inouesh@kochi2.hosp.go.jp

Sponsor
Institute National Hospital Organization National Kochi Hospital
Institute
Department

Funding Source
Organization National Hospital Organization National Kochi Hospital
Organization
Division
Category of Funding Organization Other
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 独立行政法人国立病院機構高知病院

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 04 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 08 Month 03 Day
Date of IRB
2019 Year 04 Month 10 Day
Anticipated trial start date
2017 Year 08 Month 04 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 03 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 31 Day
Date analysis concluded
2019 Year 06 Month 09 Day

Other
Other related information

Management information
Registered date
2017 Year 08 Month 02 Day
Last modified on
2019 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032552

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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