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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035382
Receipt No. 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

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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
Email 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
Email k.ishido@kitasato-u.ac.jp

Sponsor
Institute Kitasato University
Institute
Department

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
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
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
URL(English) https://upload.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


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