UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010398 |
|---|---|
| Receipt number | R000012163 |
| Scientific Title | Clinical effect of polaprezinc on cicatricial stenosis and stomach discharge function accompanied by gastric ulcer healing after endoscopic submucosal dissection. |
| Date of disclosure of the study information | 2013/04/02 |
| Last modified on | 2013/04/03 16:07:28 |
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Basic information
Public title
Clinical effect of polaprezinc on cicatricial stenosis and stomach discharge function accompanied by gastric ulcer healing after endoscopic submucosal dissection.
Acronym
Clinical effect of polaprezinc on cicatricial stenosis and stomach discharge function accompanied by gastric ulcer healing after endoscopic submucosal dissection.
Scientific Title
Clinical effect of polaprezinc on cicatricial stenosis and stomach discharge function accompanied by gastric ulcer healing after endoscopic submucosal dissection.
Scientific Title:Acronym
Clinical effect of polaprezinc on cicatricial stenosis and stomach discharge function accompanied by gastric ulcer healing after endoscopic submucosal dissection.
Region
| Japan |
Condition
Condition
Gastric neoplasm performed ESD
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of polaprezinc on cicatricial stenosis and stomach discharge function at the process of gastric secretion inhibitor for stomach ulcer after endoscopic submucosal dessection.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
level of cicatrical stenosis after endoscopic submucosal dissection
Key secondary outcomes
1 scar transition rate
2 decrease rate in ulcer size
3 level of granulation tuberalis
4 level of food debris
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Promac Tablets 75
Interventions/Control_2
Takepron Tablets 30
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
Inclusion criteria are patients who are administered endoscopic submucosal dissection (ESD) and are over 20 years old.
Key exclusion criteria
1) history of anaphylaxis to PPI
2) history anaphylaxis to polaprezinc
3) patients with zinc excess or doubt to zinc excess
4) patients with copper deficiency or doubt to copper deficiency
5) patients with aspirin asthma
6) patients with cicatrix at antrum of stomach
7) disagreement to the trial
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Osawa |
Organization
Jichi Medical University Hospital
Division name
Department of Gastroenterology
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, 329-0498 Japan
TEL
0285-58-7348
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshimasa Miura |
Organization
Jichi Medical University Hospital
Division name
Department of Gastroenterology
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken, 329-0498 Japan
TEL
0285-58-7348
Homepage URL
y-miura@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Zeria Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
自治医科大学附属病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | Month | 02 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 11 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2015 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 04 | Month | 02 | Day |
Last modified on
| 2013 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012163
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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