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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000009230
Receipt No. 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

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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
Email 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
Email mizkaz0809@oita-u.ac.jp

Sponsor
Institute Department of Gastroenterology,
Faculty of Medicine, Oita University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010839

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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