UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031633 |
|---|---|
| Receipt number | 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 13:26:31 |
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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
| Japan |
Condition
Condition
Reflux esophagitis
Classification by specialty
| Gastroenterology |
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
| Medicine |
Interventions/Control_1
PCAB:
Vonoprazan 20mg/day 8 weeks
Interventions/Control_2
PPI:
Rabeprazole 10mg/day 8 weeks
or
Esomeprazole 20mg/day 8 weeks
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)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.
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.
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Shin |
| Middle name | |
| Last name | Maeda |
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
| 1st name | Toshihide |
| Middle name | |
| Last name | Tamura |
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 or person
Institute
Yokohama City University (Basic research expenditures)
Institute
Department
Personal name
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
| 2018 | Year | 03 | Month | 09 | 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
| 2016 | Year | 01 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 04 | 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 | 03 | Month | 08 | Day |
Last modified on
| 2020 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036110
