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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000019372
Receipt No. R000022398
Scientific Title Comparing P-CAB to PPI of the effect of Helicobacter pylori testing(urea breath test, stool antigen), and ulcer healing effect after ESD, compared to the post-bleeding
Date of disclosure of the study information 2015/10/15
Last modified on 2015/10/15

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Basic information
Public title Comparing P-CAB to PPI of the effect of Helicobacter pylori testing(urea breath test, stool antigen), and ulcer healing effect after ESD, compared to the post-bleeding
Acronym P-CAB effects on helicopter flights in antigen -UBT, Japan
Scientific Title Comparing P-CAB to PPI of the effect of Helicobacter pylori testing(urea breath test, stool antigen), and ulcer healing effect after ESD, compared to the post-bleeding
Scientific Title:Acronym P-CAB effects on helicopter flights in antigen -UBT, Japan
Region
Japan

Condition
Condition Gastric Adenoma ,Early Gastric Cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Clarify UBT of P-CAB and the influence on antigen during the flight (false-negative rate in particular) in comparison with the PPI, and clarify bleeding protective efficacy more after an ulcer healing promotion.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The P-CAB-administered group when compared to the PPI administered group
1.UBT and fecal proof of inspection accuracy of the superiority of antigen
2.evaluation of the superiority of ulcer healing after ESD
Key secondary outcomes Classify and evaluate in
1.Projectile bleeding
2.Gush-related bleeding
3.Exposure blood vessel
4.Blood clot adhesion
5.Black ulcer
6.Beautiful ulcer
Use a major forceps in Day7 and day28, and find an ulcer area with the approximate value of the area of the oval, and evaluate the reduction ratio, at the time of the endoscope enforcement greater curvature by LCI (Linked color image: Fuji Film Corporation) and perform one place of biopsy and evaluate atrophy, inflammatory cell permeation by Sydney classification

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
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 Device,equipment Maneuver
Interventions/Control_1 PPI treatment (Takepron) after the ESD(A group)
Interventions/Control_2 P-CAB treatment (Takecab) after the ESD(B group)
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 who have been diagnosed (including suspected)gastric adenoma or early gastric cancer in the treatment before endoscopic diagnosis, (including suspected)
To be an adaptive one of the following case of early gastric cancer.
1) 2cm no differentiated cancer of the following ulcer, gross intra mucosal cancer
2)ulcer without differentiated more than 2cm, gross intramucosal cancer
3)3cm following ulcer of a differentiated, gross intramucosal cancer
4)2cm following ulcer without undifferentiated, gross intra mucosal cancer
2.Patients without Helicobacter pylori history.
3.Gender:unquestioned, Age: patient age at the time of consent acquisition is greater than or equal to 20 years old.
4.Patients Performance Status (PS) is either 0, 1, 2.
5.Patients are able to follow a minimum of 6 months after treatment.
6. Patients who meet the ALT/ALT=<100 IU/L, Cr=<2.0 mg/dl, PT-INR>=80%
7. Patients can receive informed consent from the person
Key exclusion criteria 1.acute abdomen
2.Patients with eradication history of Helicobacter pylori.
3.Patients who are already oral proton pump inhibitor (PPI).
4.Patients of the remaining stomach cancer
5.Patients with gastric tube cancer
6.Patients with endoscopic treatment history with respect to the upper gastrointestinal tract lesions within registered 28 days prior to.
7.Patients with endoscopic therapy plans with respect to the upper gastrointestinal tract lesions within 28 days after treatment.
8.Patients with poorly controlled diabetes (HbA1c> 8.0%)
9.Female patient who during pregnancy or possibility of pregnancy or breastfeeding
10.Patient has been merged with psychosis or psychiatric symptoms, to participate in the test it seems to be difficult
11.Patients complicated with respiratory disease and receiving administration of clarithromycin.
12.Patient corresponding to the contraindication matters of study drug.
13.Other patients principal investigator or researcher has determined to be inappropriate as a target.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Osawa,M.D.,Ph.D
Organization Jichi Medical University
Division name Department of Internal Medicine
Zip code
Address 3311-1 Yakushiji,Shimomituke,Tochigi, JAPAN
TEL 0285-58-7539
Email osawa@jichi.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshimasa Miura,M.D
Organization Jichi Medical University
Division name Department of Internal Medicine
Zip code
Address 3311-1 Yakushiji,Shimomituke,Tochigi, JAPAN
TEL 0285-58-7539
Homepage URL
Email y-miura@jichi.ac.jp

Sponsor
Institute Jichi Medical University
Institute
Department

Funding Source
Organization FUJIILM Medical Corporation
Organization
Division
Category of Funding Organization Profit organization
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
2015 Year 10 Month 15 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
2015 Year 05 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 10 Month 31 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
2015 Year 10 Month 15 Day
Last modified on
2015 Year 10 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022398

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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