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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030941
Receipt No. R000035335
Scientific Title Symptomatic effect and serum gastrin level after treatment with proton pump inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker
Date of disclosure of the study information 2018/01/23
Last modified on 2018/01/22

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Basic information
Public title Symptomatic effect and serum gastrin level after treatment with proton pump
inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker
Acronym Symptomatic effect and serum gastrin level after treatment with proton pump
inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker
Scientific Title Symptomatic effect and serum gastrin level after treatment with proton pump
inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker
Scientific Title:Acronym Symptomatic effect and serum gastrin level after treatment with proton pump
inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker
Region
Japan

Condition
Condition GERD
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective of this study was to investigate the effects of Esomeprazole 20 mg once a day for patients with Pcab resistant reflux esophagitis with remnant symptoms even after oral administration of Vonoprazan 20 mg for 4 weeks or more after four weeks of effect on gastrointestinal symptoms Are compared and examined using various scores of FSSG which is a patient self-entry questionnaire as an index.
We will also examine changes in symptoms other than GERD symptoms including safety before and after switching.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes the change in FSSG total score before and 4 weeks after treatment with Esomeprazole
Key secondary outcomes 1. Score change of each of the reflux score and exercise failure score after 2 or 4 weeks evaluated by the FSSG questionnaire
2. Total core change after 2 weeks evaluated by FSSG questionnaire
3. Therapeutic reactivity after 2 or 4 weeks evaluated in the GOS questionnaire
4. Serum gastrin level change before and after esomeprazole administration
5. tolerability during administration of both drugs

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Esomeprazole 20 mg capsule
Orally administered once a day
for 4 weeks
Interventions/Control_2
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.Patient who gave written consent to study participation by free documentation and verbally enough explanation.
2.Patients aged 20 years and older at 2 years of age
3.Three patients diagnosed as reflux esophagitis.
4. Patients with Pcab resistant reflux esophagitis whose gastrointestinal symptoms remained despite intake of Vonoprazan for 4 weeks or more at the time of registration.
5.Patients with total score of 8 or more in the 5FSSG interview sheet.
Key exclusion criteria (1) Patients with warning findings such as vomiting subject to endoscopic examination, gastrointestinal bleeding (including findings of hematemesis, venous drainage, anemia, etc.), and rapid weight loss.
(2) Patients with malignant lesions confirmed or suspected of malignant lesions.
(3) A patient with a history of gastrointestinal resection and vagotomy.
(4) Patients with irritable bowel syndrome.
(5) Patients who are difficult to participate in this study due to mergers of severe liver disease, kidney disease, heart disease etc.
(6) Pregnant women, lactating women or lactating women who may be pregnant.
(7) Patients who other doctors judged inappropriate as subjects of this study.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shinichi Ishihara
Organization Ishihara Gastroenterology Clinic
Division name Gastroenterology
Zip code
Address Ikano cho 1852-1,Zentsuji city ,Kagawa prefecture
TEL 0877-63-6677
Email ccy63890@yahoo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinichi Ishihara
Organization Ishihara Gastroenterology Clinic
Division name Gastroenterology
Zip code
Address Ikano cho 1852-1,Zentsuji city ,Kagawa prefecture
TEL 0877-63-6677
Homepage URL
Email ccy63890@yahoo.co.jp

Sponsor
Institute Ishihara Gastroenterology Clinic
Institute
Department

Funding Source
Organization Ishihara 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

Other administrative information
Date of disclosure of the study information
2018 Year 01 Month 23 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 05 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 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
2018 Year 01 Month 22 Day
Last modified on
2018 Year 01 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035335

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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