UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006625 |
|---|---|
| Receipt number | R000007838 |
| Scientific Title | Proof of rebamipide induced mucosal effect for NSAIDs injuries of small bowel |
| Date of disclosure of the study information | 2011/10/28 |
| Last modified on | 2012/04/30 16:37:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Proof of rebamipide induced mucosal effect for NSAIDs injuries of small bowel
Acronym
Treatment of NSAIDs induced small bowel injuries
Scientific Title
Proof of rebamipide induced mucosal effect for NSAIDs injuries of small bowel
Scientific Title:Acronym
Treatment of NSAIDs induced small bowel injuries
Region
| Japan |
Condition
Condition
NSAIDs induced mucosal injuries of small bowel
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the healing effect of rebamipide in patients with NSAID and/or low-dose aspirin-induced small intestinal injuries.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Capsule endoscopic findings (ulcer, erosion, erythema, bleeding spot, denuded mucosa)
Key secondary outcomes
adverse effect
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
rebamipide
Interventions/Control_2
placebo
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
| 95 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)Patients who diagnosed small intestinal mucosal damages by balloon endoscopy, capsule endoscopy, esophagogastroduodenal endoscopy, and colonoscopy
(2)Patients who took NSAIDs and/or low-dose aspirin without bleeding
Key exclusion criteria
(1)Patients who need active treatment for small bowel lesion
(2)Patients who have hitstory of small bowel disease such as Crohn's disease
(3)Patients whose lesions are associated with other factors except NSAIDs
(4)Patients who need high-dose streoid therapy
(5)Contraindication of capsule endoscopy
(6)Patients who have severe liver, renal, and cardiopulmonary dysfunctions, malignant diseases
(7)Pregnant patients
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mototsugu KATO |
Organization
Hokkaido University Hospital
Division name
Endoscopy
Zip code
Address
W-5,N-14, Kita-ku, Sapporo, Japan
TEL
+81-11-716-1161
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mototsugu KATO |
Organization
Hokkaido University Hospital
Division name
Endoscopy
Zip code
Address
W-5,N-14, Kita-ku, Sapporo, Japan
TEL
+81-11-716-1161
Homepage URL
m-kato@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido small bowel disease conference
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
北海道大学病院（北海道）
札幌医科大学病院（北海道）
小樽掖済会病院（北海道）
札幌厚生病院（北海道）
市立旭川病院（北海道）
札幌整形循環器科病院（北海道）
士別市立病院（北海道）
富良野協会病院（北海道）
北海道がんセンター（北海道）
岩見沢市立総合病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 28 | 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 | 09 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 28 | Day |
Last modified on
| 2012 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007838
