UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009230 |
|---|---|
| Receipt number | R000010839 |
| Scientific Title | Efficacy of irsogladine maleate and for the prevention of gastric mucosal lesions induced by aspirin: a randomized, controlled, prospective study. |
| Date of disclosure of the study information | 2012/10/31 |
| Last modified on | 2013/11/15 22:56:51 |
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Basic information
Public title
Efficacy of irsogladine maleate and for the prevention of gastric mucosal lesions induced by aspirin: a randomized, controlled, prospective study.
Acronym
Preventive efficacy for aspirin induced gastric mucosal lesions by irsogladine
Scientific Title
Efficacy of irsogladine maleate and for the prevention of gastric mucosal lesions induced by aspirin: a randomized, controlled, prospective study.
Scientific Title:Acronym
Preventive efficacy for aspirin induced gastric mucosal lesions by irsogladine
Region
| Japan |
Condition
Condition
Gastritis
Classification by specialty
| Gastroenterology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate whether irsogladine or PPI can prevent gastritis induced by 2 weeks' administration of aspirin in healthy volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
LANZA scores at 2 weeks of the treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Aspirin 100mg/day p.o. for 2 weeks
Interventions/Control_2
Aspirin 100mg/day and Irsogladine 4mg/day p.o. for 2 weeks
Interventions/Control_3
Aspirin 100mg/day and Lansoprazole 15mg/day p.o. for 2 weeks
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
H. pylori negative healthy subjects aged from 20 to 65 years when the written informed consent is obtained
Key exclusion criteria
1)Subjects with a history of peptic ulcer or gastrointestinal bleeding
2)Subjects with significant hepatic disease, renal disease, heart disease, or respiratory disease
3)Subjects with a history of gastrointestinal surgery other than appendectomy
4)Subjects orally taking or planning to orally take drug other than antiulcer drug or NSAIDs
5)Pregnancy or Lactation
6)Subjects whom otherwise the investigator determined ineligible as the subject
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunari Murakami |
Organization
Faculty of Medicine, Oita University
Division name
Department of Gastroenterology
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita
TEL
097-586-6193
murakam@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuhiro Mizukami |
Organization
Faculty of Medicine, Oita University
Division name
Department of Gastroenterology
Zip code
Address
1-1 Idaigaoka, Hasama-machi, Yufu-City, Oita
TEL
097-586-6193
Homepage URL
mizkaz0809@oita-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology,
Faculty of Medicine, Oita University
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
| 2012 | Year | 10 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 10 | Month | 31 | Day |
Last modified on
| 2013 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010839
