UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035382 |
|---|---|
| Receipt number | R000040313 |
| Scientific Title | Compare the efficacy of diagnostic treatment with P-CAB and PPI before to do endoscopy for GERD patients. |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2018/12/27 16:32:57 |
* 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
Compare the efficacy of diagnostic treatment with P-CAB and PPI before to do endoscopy for GERD patients.
Acronym
Compare the efficacy of treatment with P-CAB and PPI in patients with GERD.
Scientific Title
Compare the efficacy of diagnostic treatment with P-CAB and PPI before to do endoscopy for GERD patients.
Scientific Title:Acronym
Compare the efficacy of treatment with P-CAB and PPI in patients with GERD.
Region
| Japan |
Condition
Condition
Gastroesophageal reflux disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of Vonoprazan(20mg/day) vs Esomeprazole(20mg/day) for 1week treatment in patients with GERD by assessing the time(days) to be GERD symptom relief before to do endoscopy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time(days) to GERD symptom relief.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are 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
Vonoprazan(Takecab)20mg once a day in the mornimg.
Interventions/Control_2
Esomeprazole(Nexium)20mg once a day in the mornimg.
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 whose chief complain are heartburn or acetic acid more than 2days in a week.
2.Patients who are at least 20 years of age.
3.Patients whose main organs work.
4.Patients who have given written consent to participate in the study.
Key exclusion criteria
1.Patients with a history of hypersensitivity to components of Vonoprazan and Esomeprazole.
2.Patients taking PPI including Vonoprazan and Esomeprazole.
3.Patients taking Atazanavir sulfate and Rilpivirine hydrochloride.
4.Patients who are diagnosed Zollinger-Ellison syndrome and Pernicious anemia.
5.Patients who have complicated other severe diseases and whose clinical trials can not be safety performed or whose effect judgment is difficult.
6.Patients with malignant tumor complications.
7.Patients with a history of surgery of the upper gastrointestinal tract including the stomach and esophagus.
8.Patients who may be pregnant or pregnant.
9.Patients who judged by physician inappropriate to participate in clinical trials.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akihiro Tamaki |
Organization
Kitasato University
Division name
Internal gastroenterology
Zip code
Address
1-15-1 Kitasato Minami,Sagamihara,Kanagawa,Japan
TEL
042-778-8111
a.tamaki@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kengi Ishido |
Organization
Kitasato University
Division name
Internal gastroenterology
Zip code
Address
1-15-1 Kitasato Minami,Sagamihara,Kanagawa,Japan
TEL
042-778-8111
Homepage URL
k.ishido@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University
Institute
Department
Personal name
Funding Source
Organization
None
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
| 2019 | Year | 03 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 03 | 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 | 12 | Month | 27 | Day |
Last modified on
| 2018 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040313
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
