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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005362
Receipt No. R000006363
Scientific Title Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs).
Date of disclosure of the study information 2011/04/01
Last modified on 2013/04/01

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Basic information
Public title Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs).
Acronym Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by NSAIDs.
Scientific Title Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs).
Scientific Title:Acronym Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by NSAIDs.
Region
Japan

Condition
Condition Patients with rheumatoid arthritis with anemia taking NSAIDs
Classification by specialty
Gastroenterology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine the efficacy of mesalazine for the treatment of intestinal injury caused by NSAIDs
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Endoscopic findings by capsule endoscopy.
Side effects due to the mesalazine treatment.
Key secondary outcomes Patients' joint and abdominal symptoms. Serum cytokines. Fecal calprotectin

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treatment with mesalazine
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
70 years-old >=
Gender Male and Female
Key inclusion criteria 1)Rheumatoid arthritis patients aged older than 20y and younger than 70 y who were taking NSAIDs for more than 3 mo and will take NSAIDs for the additional 8 w.
2)The patients with anemia (Hg levels lower than 13.8 g/dl (men) 12.0 g/dl(women) and without abnormalities in the liver and renal function tests.
Key exclusion criteria Patients treated with mesalazine or salicylic acid 2 weeks proior to the entry of this study.
Patients with escalating the dose of anti-rheumatoid arthritis drugs such as aspirins or proton pump inhitors.
Patients took gastroprotective agents such as rebamipide, ecabet sodium, misoprostol.
Patients being treated with high-dose corticosteroids (more than 15 mg/day of prednisolone.
Patients treated with biologics 90 days prior to the entry of this study.
Patients who were allergic to or suffered from side effects by mesalazine of salicylic acids.
Patients incapable of swallowing capsule endoscopy.
Patients suspicious of intestinal strictures.
Patients with malignancies.
Pregnancy or possible pregnancy.
Patients with side effects by other previous clinical studies.
Patients who were considered unsuitable for this study by doctors.
Target sample size 13

Research contact person
Name of lead principal investigator
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
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Medicin
Division name Department of Gastroenterology and Hepatology
Zip code
Address
TEL
Homepage URL
Email hiijima@gh.med.osaka-u.ac.jp

Sponsor
Institute Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Department of Gastroenterology and Hepatology, 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
2011 Year 04 Month 01 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
2011 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2012 Year 11 Month 30 Day
Date of closure to data entry
2012 Year 11 Month 30 Day
Date trial data considered complete
2013 Year 03 Month 28 Day
Date analysis concluded
2013 Year 03 Month 28 Day

Other
Other related information

Management information
Registered date
2011 Year 04 Month 01 Day
Last modified on
2013 Year 04 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006363

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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