UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007540 |
|---|---|
| Receipt number | 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 10:44:43 |
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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
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
Sponsor or person
Institute
Second Department of Internal Medicine, Osaka Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008909
