UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027069
Receipt No. R000031032
Scientific Title Symptom relief of gastric acid suppressants in patients with reflux esophagitis - Randomized controlled comparative study of vonoprazan and esomeprazole -
Date of disclosure of the study information 2017/04/20
Last modified on 2017/04/19

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Symptom relief of gastric acid suppressants in patients with reflux esophagitis
- Randomized controlled comparative study of vonoprazan and esomeprazole -
Acronym Symptom relief of gastric acid suppressants in patients with reflux esophagitis
Scientific Title Symptom relief of gastric acid suppressants in patients with reflux esophagitis
- Randomized controlled comparative study of vonoprazan and esomeprazole -
Scientific Title:Acronym Symptom relief of gastric acid suppressants in patients with reflux esophagitis
Region
Japan

Condition
Condition Reflex esophagitis patients
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate GERD related symptom relief of vonoprazan and esomeprazole
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes GOS Questionnaire after 84-week treatment
Key secondary outcomes 1:The Change of individual score and the improvement of symptom (heartburn,regurgitation) evaluated using GOS/FSSG after4,8-week treatment
2:The improvement of symptom (epigastric pain, nausea, vomiting) evaluated using GOS/FSSG after 4,8-week treatment
3:Treatment response evaluated by GOS/FSSG after 4,8-week 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 Vonoprazan 20mg p.o. once daily, 4weeks,and Vonoprazan 10mg p.o. once daily, 4weeks
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 or in the past.
3:Patients who answered score of 4 (moderate problem) or severer in questions about heartburn, Q2 and/or regurgitation, Q3.
Key exclusion criteria 1:Patients with warning signs such as vomiting, gastrointestinal bleeding and sudden weight loss.
2:Patients with confirmed or suspected malignant diseases.
3:Patients with a history of gastrointestinal resection of vagotomy.
4:Patients with a history of irritable bowel syndrome.
5:Patients whose participation in this study would be contraindicated due to complications such as serious hepatic, renal or heart disease.
6:Pregnant patients, possibly pregnant or lactating women.
7:Patients judged as inadequate in participation 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 Masahiro Hirano
Organization Hirano Gastroenterology Clinic
Division name Gastroenterology
Zip code
Address 2-3029-2,Onuki town, Nobeoka city, Miyazaki prefecture
TEL 0982-26-7070
Email gihirano@gaea.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Hirano
Organization Hirano Gastroenterology Clinic
Division name Gastroenterology
Zip code
Address 2-3029-2,Onuki town, Nobeoka city, Miyazaki prefecture
TEL 0982-26-7070
Homepage URL
Email gihirano@gaea.ocn.ne.jp

Sponsor
Institute Hirano Gastroenterology Clinic
Institute
Department

Funding Source
Organization Hirano Gastroenterology Clinic
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 平野消化器内科(Hirano Gastroenterology Clinic)

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 20 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
2017 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 04 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 04 Month 19 Day
Last modified on
2017 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031032

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.