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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000005362 |
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Date of registration:
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01/04/2011 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs).
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Scientific title:
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Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by non-steroidal anti-inflammatory drugs(NSAIDs). - Clinical study for the efficacy of mesalazine for the treatment of small bowel injury caused by NSAIDs. |
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Date of first enrolment:
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2011/04/01 |
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Target sample size:
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13 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006363 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Address:
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Japan |
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Telephone:
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Email:
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hiijima@gh.med.osaka-u.ac.jp |
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Affiliation:
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Osaka University Graduate School of Medicin Department of Gastroenterology and Hepatology |
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Name:
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Hideki Iijima |
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Address:
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2-2 Yamadaoka, Suita, Osaka 565-0871, Japan
Japan |
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Telephone:
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Email:
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Affiliation:
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Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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.
Age minimum:
20years-old
Age maximum:
70years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Patients with rheumatoid arthritis with anemia taking NSAIDs
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Intervention(s)
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Treatment with mesalazine
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Primary Outcome(s)
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Endoscopic findings by capsule endoscopy. Side effects due to the mesalazine treatment.
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Secondary Outcome(s)
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Patients' joint and abdominal symptoms. Serum cytokines. Fecal calprotectin
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Source(s) of Monetary Support
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Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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30/11/2012 |
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URL:
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