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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000031633 |
Receipt No. | R000036110 |
Scientific Title | A randomized controlled trial comparing PCAB and PPI therapy for Los Angeles classification Grade C/D reflux esophagitis patient |
Date of disclosure of the study information | 2018/03/09 |
Last modified on | 2020/02/06 |
Basic information | ||
Public title | A randomized controlled trial comparing PCAB and PPI therapy for Los Angeles classification Grade C/D reflux esophagitis patient | |
Acronym | RCT comparing PCAB and PPI for reflux esophagitis | |
Scientific Title | A randomized controlled trial comparing PCAB and PPI therapy for Los Angeles classification Grade C/D reflux esophagitis patient | |
Scientific Title:Acronym | RCT comparing PCAB and PPI for reflux esophagitis | |
Region |
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Condition | ||
Condition | Reflux esophagitis | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To assess the superiority of PCAB therapy compared to PPI therapy for Los Angeles classification Grade C/D severe reflux esophagitis patient |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Endoscopic cure rate :a rate becoming Las Angeles classification grade M or N. |
Key secondary outcomes | Subjective symptoms disappearance rate :Using questionnaire for GERD symptom: Frequency Scale for the Symptoms of GERD (FSSG, F-scale), the rate is defined as (pre F-scale score - post F-scale score)/(pre F-scale score)*100. F-scale of pre and post 4 weeks and 8 weeks is used. |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Open -no one is blinded |
Control | Active |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Treatment | |
Type of intervention |
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Interventions/Control_1 | PCAB: Vonoprazan 20mg/day 8 weeks |
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Interventions/Control_2 | PPI: Rabeprazole 10mg/day 8 weeks or Esomeprazole 20mg/day 8 weeks |
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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)A patient who was endoscopically diagnosed as Los Angeles classification Grade C/D severe reflux esophagitis. (2)A patient who have treatment history of PPI or PCAB. (3)A patient who is ambulatory and who can answer the questionnaire. (4)A patient who give a written informed consent. |
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Key exclusion criteria | (1)A patient with history of gastrectomy which may cause regurgitation of bile acid or pancreatic juice. (2)A patient who use PPI or H2RA already. (3)A patient with pregnancy. (4)A patient with lactation. (5)Past history of allergy for the drug used in this study. (6)Severe liver dysfunction, severe renal dysfunction, severe heart dysfunction. (7)A patient who is disqualified for the study by physicians. |
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Target sample size | 160 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Yokohama City University Hospital | ||||||
Division name | Gastroenterology | ||||||
Zip code | 236-0004 | ||||||
Address | Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan | ||||||
TEL | 045-787-2326 | ||||||
smaeda@med.yokohama-cu.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Yokohama City University Hospital | ||||||
Division name | Gastroenterology | ||||||
Zip code | 236-0004 | ||||||
Address | Fukuura3-9, Kanazawa, Yokohama, Kanagawa, Japan | ||||||
TEL | 045-787-2326 | ||||||
Homepage URL | |||||||
Tamura.Toshihide@gmail.com |
Sponsor | |
Institute | Yokohama City University (Basic research expenditures) |
Institute | |
Department |
Funding Source | |
Organization | Yokohama City University (Basic research expenditures) |
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 | Yokohama City University Ethics Committee |
Address | Fukuura 3-9, Kanazawa-ku, Yokohama city, Kanagawa |
Tel | 045-370-7627 |
rinri@yokohama-cu.ac.jp |
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 | Open public recruiting | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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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=R000036110 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |