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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000658
Receipt No. R000000792
Scientific Title Effects of rebamipide on nonsteroidal anti-inflammatory drugs-induced small bowel injury
Date of disclosure of the study information 2007/03/29
Last modified on 2011/03/31

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Basic information
Public title Effects of rebamipide on nonsteroidal anti-inflammatory drugs-induced small bowel injury
Acronym Effects of rebamipide on NSAIDs-induced small bowel injury
Scientific Title Effects of rebamipide on nonsteroidal anti-inflammatory drugs-induced small bowel injury
Scientific Title:Acronym Effects of rebamipide on NSAIDs-induced small bowel injury
Region
Japan

Condition
Condition Small bowel injuries
Classification by specialty
Gastroenterology Clinical immunology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect of rebamipide on small bowel injury caused by loxoprofen, a nonsteroidal anti-inflammatory drug, in patients with rheumatoid arthritis
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Capsule endoscopic findings (number of ulcers/erosions and red spots)
Key secondary outcomes Symptom assessment (anemia, melena, complications)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Patients in the treatment group receive rebamipide 300 mg/day for 8 weeks.
Interventions/Control_2 Patients in the control group do not receive rebamipide.
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

Not applicable
Gender Male and Female
Key inclusion criteria The rheumatoid arthritis patients taking loxoprofen more than three months
Key exclusion criteria 1. Dysphagia.
2. Pregnant, possibly pregnant, or lactating women.
3. With intestinal stricture or intestinal fistula, diagnosed by diagnostic image or past clinical inspection.
4. Using cardiac pacemaker or other self-contained medical electronics.
5. The subject of any other clinical test/trial which will affect the results this study.
6. Can not comply with the study requirements or cannot follow instructions for the device.
7. Extensive esophageal hiatal hernia.
8. Life-threatening disorder.
9. Abdominal radiotherapy in past.
10. Do not agree to remove the capsule either by endoscopically or surgically when retention occurred.
11. Allergic or idiosyncratic to the drug.
12. Inadequate to entry judged by investigators.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshio Watanabe
Organization Osaka City University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585
TEL 06-6645-3811
Email

Public contact
Name of contact person
1st name
Middle name
Last name Toshio Watanabe
Organization Osaka City University Graduate School of Medicine
Division name Department of Gastroenterology
Zip code
Address 1-4-3 Asahi-machi, Abeno-ku, Osaka 545-8585
TEL 06-6645-3811
Homepage URL
Email watanabet@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University Graduate School of Medicine
Institute
Department

Funding Source
Organization Osaka City University Graduate School of Medicine
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

Other administrative information
Date of disclosure of the study information
2007 Year 03 Month 29 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
2006 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2007 Year 03 Month 01 Day
Last follow-up date
2008 Year 10 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
2007 Year 03 Month 28 Day
Last modified on
2011 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000792

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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