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UMIN-CTR Clinical Trial |
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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 |
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 |
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Acronym | Symptomatic effect and serum gastrin level after treatment with proton pump
inhibitor in GERD investigation in partial responder to potassium-competitive acid blocker |
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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 |
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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 |
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Region |
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Condition | ||
Condition | GERD | |
Classification by specialty |
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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 |
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Interventions/Control_1 | Esomeprazole 20 mg capsule
Orally administered once a day for 4 weeks |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 25 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Ishihara Gastroenterology Clinic | ||||||
Division name | Gastroenterology | ||||||
Zip code | |||||||
Address | Ikano cho 1852-1,Zentsuji city ,Kagawa prefecture | ||||||
TEL | 0877-63-6677 | ||||||
ccy63890@yahoo.co.jp |
Public contact | |||||||
Name of contact person |
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Organization | Ishihara Gastroenterology Clinic | ||||||
Division name | Gastroenterology | ||||||
Zip code | |||||||
Address | Ikano cho 1852-1,Zentsuji city ,Kagawa prefecture | ||||||
TEL | 0877-63-6677 | ||||||
Homepage URL | |||||||
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |