UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010772 |
|---|---|
| Receipt number | 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 17:49:37 |
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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
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
in2097@poh.osaka-med.ac.jp
Sponsor or person
Institute
Research Organization for Gastroenterological Disease Treatment
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012592
