UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003258 |
|---|---|
| Receipt number | R000003942 |
| Scientific Title | The evaluation of intestinal permeability for damage of mucosal injury from NSAIDS |
| Date of disclosure of the study information | 2010/04/01 |
| Last modified on | 2012/03/27 13:34:51 |
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Basic information
Public title
The evaluation of intestinal permeability for damage of mucosal injury from NSAIDS
Acronym
Evaluation of intestinal permeability
Scientific Title
The evaluation of intestinal permeability for damage of mucosal injury from NSAIDS
Scientific Title:Acronym
Evaluation of intestinal permeability
Region
| Japan |
Condition
Condition
Volunteer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the permeability change from severity of intestinal injury
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the correlation between various sugars permeability of Stomach, Small intestine and Large intestine and injury by observation of CE
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Dicrofenac sodium 25mg 3times/day
+Placebo 3times/day
+Omeprazole20mg/day for 7days
Interventions/Control_2
Dicrofenac25mg 3times/day
+Rebamipide300mg/day
+Omeprazole20mg/day for 7days
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients who have no mucosal injury
2) Patients who have signed the informed consent
Key exclusion criteria
1) Patients who have allergy for study drugs.
2) Patients who got intestinal operation.
3) Patients who suffer from ileus.
4) Patients who fit the pacemaker.
5) Patients who take calcium antagonist, nitrous acid drug, NSAIDS, anti ulcer drug, and alcohol ordinary before 2weeks.
6) Patients who have diabetes.
7) Patients who have renal failure and liver failure.
8) Patients who have heart failure.
9) Patients who have (have been suspected) renal infection.
10) Patients whom doctor judged as inadequate.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Sasaki |
Organization
Aichi Medical University
Division name
Gastroenterology
Zip code
Address
21, Karimata, Yasagoaza, Ooaza, Nagakute-cho, Aichi-gun, Aichi 480-1195, Japan
TEL
+81-561-62-3311
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Sasaki |
Organization
Aichi Medical University
Division name
Gastroenterology
Zip code
Address
21, Karimata, Yasagoaza, Ooaza, Nagakute-cho, Aichi-gun, Aichi 480-1195, Japan
TEL
+81-561-62-3311
Homepage URL
msasaki@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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
| 2010 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 02 | Month | 25 | Day |
Last modified on
| 2012 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003942
| 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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| Registered date | File name |
