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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000010772
Receipt No. R000012592
Scientific Title Study on effect of Helicobacter pylori eradication therapy on ulcer healing after endoscopic submucosal dissection for gastric tumor
Date of disclosure of the study information 2013/05/24
Last modified on 2016/03/04

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Basic information
Public title Study on effect of Helicobacter pylori eradication therapy on ulcer healing after endoscopic submucosal dissection for gastric tumor
Acronym Study on effect of Helicobacter pylori eradication therapy on ulcer healing after endoscopic submucosal dissection for gastric tumor
Scientific Title Study on effect of Helicobacter pylori eradication therapy on ulcer healing after endoscopic submucosal dissection for gastric tumor
Scientific Title:Acronym Study on effect of Helicobacter pylori eradication therapy on ulcer healing after endoscopic submucosal dissection for gastric tumor
Region
Japan

Condition
Condition H. pylori-positive gastric tumor (early gastric cancer or gastric adenoma)
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study will examine whether or not H. pylori eradication therapy immediately after ESD will affect artificial ulcer healing.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ulcer scarring rate at 8 weeks (56 days) after the start of allocation treatment.
Key secondary outcomes

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 Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After ESD, 20 mg of omeprazole will be intravenously administered twice a day for 2 days. After that, esomeprazole 20 mg, amoxicillin 750 mg, and clarithromycin 400 mg will be orally administered twice a day for 7 days. Subsequently, esomeprazole 20 mg will be orally administered once daily for 7 weeks.
Interventions/Control_2 After ESD, 20 mg of omeprazole will be intravenously administered twice a day for 2 days. After that, esomeprazole 20 mg will be orally administered once daily for 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) early gastric cancer (absolute indication for ESD in the Gastric Cancer Treatment Guidelines) or gastric adenoma (=< 20 mm)
(2) a single gastric tumor
(3) no histry of medication or radiotherapy for other cancer within past 3 years
(4) H. pylori positive
(5) twenty years or older
(6) voluntary written informed consent to participate in the study
Key exclusion criteria (1) history of H. pylori eradication therapy
(2) concurrent gastric or duodenal ulcer, except for ulcer scarring
(3) history of upper gastrointestinal tract resection or vagotomy
(4) gastrointestinal tract warning symptoms
(5) serious hepatic disease
(6) serious renal disease
(7) currently receiving antithrombotic therapy
(8) contraindication or hypersensitivity to the study drugs
(9) pregnant, possibly pregnant and lactating woman
(10) determined as inappropriate to participate in the study by the investigator
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide Higuchi
Organization Osaka Medical College
Division name Second department of internal medicine
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL 072-683-1221
Email higuchi@poh.osaka-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshihisa Takeuchi
Organization Osaka Medical College
Division name Endoscopic Center
Zip code
Address 2-7 Daigaku-machi, Takatsuki, Osaka, Japan
TEL 072-683-1221
Homepage URL
Email in2097@poh.osaka-med.ac.jp

Sponsor
Institute Research Organization for Gastroenterological Disease Treatment
Institute
Department

Funding Source
Organization AstraZeneca K.K
Daiichi Sankyo Company, Limited
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
2013 Year 05 Month 24 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 No longer recruiting
Date of protocol fixation
2013 Year 05 Month 08 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 24 Day
Last follow-up date
2016 Year 04 Month 30 Day
Date of closure to data entry
2016 Year 06 Month 30 Day
Date trial data considered complete
2016 Year 07 Month 31 Day
Date analysis concluded
2016 Year 09 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 21 Day
Last modified on
2016 Year 03 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012592

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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