UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002554 |
|---|---|
| Receipt number | R000003120 |
| Scientific Title | Evaluation of selective COX-2 inhibitor for the protection of intestinal mucosal damage in comparison to NSAID in patients with rheumatoid arthritis (Investigation by capsule endoscopy and measurement of biomarkers for rheumatoid arthritis) |
| Date of disclosure of the study information | 2009/09/28 |
| Last modified on | 2013/09/28 09:16:28 |
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Basic information
Public title
Evaluation of selective COX-2 inhibitor for the protection of intestinal mucosal damage in comparison to NSAID in patients with rheumatoid arthritis (Investigation by capsule endoscopy and measurement of biomarkers for rheumatoid arthritis)
Acronym
Evaluation of selective COX-2 inhibitor for the protection of intestinal mucosal damage in comparison to NSAID in rheumatoid arthritis
Scientific Title
Evaluation of selective COX-2 inhibitor for the protection of intestinal mucosal damage in comparison to NSAID in patients with rheumatoid arthritis (Investigation by capsule endoscopy and measurement of biomarkers for rheumatoid arthritis)
Scientific Title:Acronym
Evaluation of selective COX-2 inhibitor for the protection of intestinal mucosal damage in comparison to NSAID in rheumatoid arthritis
Region
| Japan |
Condition
Condition
Patients with rheumatoid arthritis
Classification by specialty
| Gastroenterology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Non-steroidal anti-inflammatory drugs(NSAIDs) are popularly used for the pain control in rheumatoid arthritis, but have several side effects influding mucosal damage in the stomach.A selective cyclooxygenage(COX)-2 selective inhibitor(Celecoxib;Celecox(R)) has a characteristics of decreasing mucosal damage compared to NSAIDs and was introduced in clinical usage in Japan last year. However, there is no clinical trial about the effect of the COX-2 selective inhibitor on the mucosal damage of the small intestine of Japanese population.Recently, capsule endoscopy (CE) can be used for the visualization of the whole small intestine non-invasively.In this study, patients with rheumatoid arthritis with long-term usage of NSAIDs are evaluated for the mucosal damage of the small intestine by CE.After this, NSAIDs are changed to Celecoxib and reevaluate for the mucosal injury in the small intestine by CE.In addition, several serologic markers related to rheumatoid arthritis are measured before and after the treatment with Celecoxib.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of mucosal damage in the small intestine by capsule endoscopy
Key secondary outcomes
1)Changes in the serologic markers of rheumatoid arthritis
2)Pain control
3)Adverse events and side effects of Celecoxib
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients with reumatoid arthritis treated with NSAID are administered with Celacox after the discontinuation of NSAID.Celecox is given twice daily 200mg each and capsule endoscopy is performed before and after the treatment with Celecox.
Interventions/Control_2
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
Patients with rheumatoid arthritis treated with NSAID more than 3 months.
Key exclusion criteria
1.Patients treated with biologics (anti-TNF antibody, anti-IL-6R antibody, etc)
2.Patients treated with corticosteroid(>10mg of prednisolone)
3.Patients treated with aspirin.
4.Patients treated with anti-ulcer drugs (misoprostol,teprenone,rebamipide,etc)
5. Patients with active peptic ulcer in stomach or duodenum
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Tsujii |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3621
mt@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Iijima |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
TEL
06-6879-3621
Homepage URL
hiijima@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University
Institute
Department
Personal name
Funding Source
Organization
Osaka University Graduate School of Medicine
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
| 2009 | Year | 09 | 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
| 2008 | Year | 11 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2011 | Year | 10 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2013 | Year | 09 | Month | 17 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 28 | Day |
Last modified on
| 2013 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003120
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