UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010958 |
|---|---|
| Receipt number | R000012793 |
| Scientific Title | Study of the improvement effect of proton pump inhibitors for gastric ulcers after endoscopic submucosal dissection (ESD): a randomized comparative study of omeprazole iv vs. esomeprazole po |
| Date of disclosure of the study information | 2013/06/13 |
| Last modified on | 2013/11/29 13:33:10 |
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Basic information
Public title
Study of the improvement effect of proton pump inhibitors for gastric ulcers after endoscopic submucosal dissection (ESD): a randomized comparative study of omeprazole iv vs. esomeprazole po
Acronym
Study of the improvement effect of proton pump inhibitors for gastric ulcers after endoscopic submucosal dissection (ESD): a randomized comparative study of omeprazole iv vs. esomeprazole po
Scientific Title
Study of the improvement effect of proton pump inhibitors for gastric ulcers after endoscopic submucosal dissection (ESD): a randomized comparative study of omeprazole iv vs. esomeprazole po
Scientific Title:Acronym
Study of the improvement effect of proton pump inhibitors for gastric ulcers after endoscopic submucosal dissection (ESD): a randomized comparative study of omeprazole iv vs. esomeprazole po
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy between esomeprazole and omeprazole on prevention of delayed bleeding from ulcer after ESD for early gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Retio of delayed bleeding
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
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 |
Interventions/Control_1
In the esomeprazole group, taking one tablets of esomeprazole from one day before ESD
Interventions/Control_2
In the omeprazole group, intravenous drip infusion of omeprazole for 2days after ESD,and taking 1 tablets of omeprazole from 2days after ESD
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 with gastric cancer treated by ESD
2.No previous chemotherapy or radiotherapy or operation for gastric cancer
3.ECOG Performance status(PS): 0, 1, 2
4.Sufficient organ functions
5.Written infromed consent
Key exclusion criteria
1.Active gastric or duodenal ulcers
2.Taking continuous systemic steroids
3.Taking NSAIDs
4.Psychiatric disease that is inappropriate for entry into this study
5.Patients whom the doctor decide as not proper for the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisashi Doyama |
Organization
Ishikawa Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-1 Kuratukihigashi, Kanazawa-shi, Ishikawa
TEL
076-237-8211
doyama.134@ipch.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinya Yamada |
Organization
Ishikawa Prefectural Central Hospital
Division name
Department of Gastroenterology
Zip code
Address
2-1 Kuratukihigashi, Kanazawa-shi, Ishikawa
TEL
076-237-8211
Homepage URL
s.yamada@ipch.jp
Sponsor or person
Institute
Department of Gastroenterology, Ishikawa Prefectural Central Hospital
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
| 2013 | Year | 06 | Month | 13 | 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
Completed
Date of protocol fixation
| 2012 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | 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
| 2013 | Year | 06 | Month | 13 | Day |
Last modified on
| 2013 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012793
