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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003258
Receipt No. 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

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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
Email

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
Email msasaki@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003942

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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