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Recruitment status Completed
Unique ID issued by UMIN UMIN000006625
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email

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
Email m-kato@med.hokudai.ac.jp

Sponsor
Institute Hokkaido small bowel disease conference
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007838


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