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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007540
Receipt No. R000008909
Scientific Title Small intestinal mucosal adaptation in the long-term administration of a NSAID and the efficacy of irsogladine maleate, a gastroprotective drug, and omeprazole in healthy volunteers: a prospective randomized trial
Date of disclosure of the study information 2012/03/21
Last modified on 2012/10/02

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Basic information
Public title Small intestinal mucosal adaptation in the long-term administration of a NSAID and the efficacy of irsogladine maleate, a gastroprotective drug, and omeprazole in healthy volunteers: a prospective randomized trial
Acronym Comparison of the Efficacy of Irsogladine and Omeprazole Against NSAIDs-Induced Small Intestinal Lesions
Scientific Title Small intestinal mucosal adaptation in the long-term administration of a NSAID and the efficacy of irsogladine maleate, a gastroprotective drug, and omeprazole in healthy volunteers: a prospective randomized trial
Scientific Title:Acronym Comparison of the Efficacy of Irsogladine and Omeprazole Against NSAIDs-Induced Small Intestinal Lesions
Region
Japan

Condition
Condition NSAID induced small intestinal lesions
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate whether a continuous NSAID administration cause further damage or not and the efficacy of irsogladine and omeprazole on such lesions.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes The number of small intestinal mucosal breaks evaluated in the capsule endoscope.
Key secondary outcomes 1. fecal calprotectin
2. hemoglobin
3. occult fecal blood test

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 irsogladine 4mg/day and dicrofenacNa75mg/day for 6weeks in oral administration
Interventions/Control_2 omeprazole 10mg/day and dicrofenacNa75mg/day for 6weeks in oral administration
After that omeprazole 10mg/day, dicrofenacNa75mg/day and irsogladine 4mg/day for another 4weeks in oral administration
Interventions/Control_3 omeprazole 10mg/day and dicrofenacNa75mg/day for 10weeks in oral administration
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Healthy adults who are 20 years or older, and less than 80 years of age at the time of obtaining
consent
2) Subjects from whom fully informed written consent based on their full understanding and their
own voluntary will was obtained when participating this study
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) Subjects with alcohol or chemical dependencies
6) Subjects with a history of intestinal obstruction, or person with suspected gastrointestinal
obstruction on other tests
7)Subjects who cannot agree that surgery may be required if capsule endoscope retained in the body
8) Subjects whom otherwise the investigator determined ineligible as the subject
Target sample size 37

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhide Higuchi
Organization Osaka Medical College
Division name Second Department of Internal Medicine
Zip code
Address 2-7 Daigakumachi Takatsuki Osaka 569-8686 Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka Medical College
Division name Second Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Second Department of Internal Medicine, Osaka Medical College
Institute
Department

Funding Source
Organization Second Department of Internal Medicine, Osaka Medical College
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 03 Month 21 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
2010 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2010 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
2012 Year 03 Month 21 Day
Last modified on
2012 Year 10 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008909

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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