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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002554
Receipt No. 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

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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
Email 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
Email hiijima@gh.med.osaka-u.ac.jp

Sponsor
Institute Osaka University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003120

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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