UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006233 |
|---|---|
| Receipt number | R000007375 |
| Scientific Title | Role of mucosal-protective agents, rebamipide and polaprezinc, in post-gastric endoscopic submucosal dissection ulcer healing, a randomized controlled study |
| Date of disclosure of the study information | 2011/08/25 |
| Last modified on | 2011/08/25 19:15:17 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Role of mucosal-protective agents, rebamipide and polaprezinc, in post-gastric endoscopic submucosal dissection ulcer healing, a randomized controlled study
Acronym
Role of mucosal-protective agents, rebamipide and polaprezinc, in post-gastric endoscopic submucosal dissection ulcer healing, a randomized controlled study
Scientific Title
Role of mucosal-protective agents, rebamipide and polaprezinc, in post-gastric endoscopic submucosal dissection ulcer healing, a randomized controlled study
Scientific Title:Acronym
Role of mucosal-protective agents, rebamipide and polaprezinc, in post-gastric endoscopic submucosal dissection ulcer healing, a randomized controlled study
Region
| Japan |
Condition
Condition
superficial gastrointestinal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We clarify the additive benefits of mucosal protective agents about the acceleration of ESD-induced ulcer healing.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
PPI with mucosal-protective agents, at least in gastric antrum, might contribute to stabilize the efficacy of post-ESD ulcer healing.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PPI
Interventions/Control_2
PPI plus REB
Interventions/Control_3
PPI plus PPZ
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the patients who undergo gastric ESD.
Key exclusion criteria
the patients who undergo additive operation.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masayuki Sawaguchi |
Organization
Hiraka general hospital
Division name
gastroenterology
Zip code
Address
3-1 yatsukuchi maegou yokote city Akita Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hiraka general hospital
Division name
gastroenterology
Zip code
Address
TEL
0182-32-5121
Homepage URL
Sponsor or person
Institute
Hiraka general hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2011 | Year | 08 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2009 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 04 | 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
| 2011 | Year | 08 | Month | 25 | Day |
Last modified on
| 2011 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007375
